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Find Breast Cancer Clinical Trials That Are Right For You
The clinical trials listed below are open in the U.S. for people with DCIS (stage 0), stage 1, stage 2, stage 3, or stage 4 (metastatic)
breast cancer. Clinical trials are available for people who are newly diagnosed with breast cancer, currently in treatment, experiencing
breast cancer recurrence, living with metastatic disease, as well as breast cancer survivors who have completed treatment.
Use the search box and filters to find a trial that’s right for you.
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(Last updated: May 08, 2024)
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Treatment
Brain Mets
BRCA1/2 (inherited)
Chemotherapy
Hormone Therapy
Leptomeningeal Disease
Radiation Oncology
Surgery
Surgery: Reconstruction
Targeted Therapy: All
Targeted Therapy: ADC
Targeted Therapy: Anti-HER2 Therapy
Targeted Therapy: CDK Inhibitors
Targeted Therapy: PARP Inhibitors
Targeted Therapy: Tumor Mutations
Targeted Therapy: Other Targeted Therapy
Vaccines and Immunotherapy
Other Treatment
Non-Treatment
Activities
Complementary and Integrative Medicine
Decision Support
Diagnosing Breast Cancer
Genetics/Family History
Having Children
Healthy/High Risk
Imaging
Lymphedema
Managing Side Effects
No Travel Required
Predicting Response to Treatment
Preventing Breast Cancer
Preventing Recurrence
Support/Education
Surveys/Interviews/Registries
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AKT
ALK
AR
BARD1
BRCA1/2 (tumor)
BRIP1
CD205
CD70
CHEK2 or CHEK1
dMMR/MSI-H
ESR1
FGFR
HER2/ERBB2
HLA
MET or C-Met
NTRK
PALB2
PIK3CA or PI3K
PTEN
RAD51
RAF (including BRAF)
RAS (KRAS or NRAS)
RB
ROS1
TP53
1
NEAREST SITE: 2 miles
Zuckerberg San Francisco General Hospital
San Francisco,CA
VISITS: 1 visit every 3 weeks, for 10 months
PHASE: III
NCT ID: NCT04457596
Two Therapies for People with Stage II-III HER2+ Breast Cancer Who Had Leftover Tumor after Receiving Neoadjuvant Therapy and Surgery
The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib Scientific Title
Purpose
To study the anti-cancer activity and side-effects of giving the antibody-drug conjugate trastuzumab emtansine/T-DM1 (Kadcyla®) and the anti-HER2 targeted therapy tucatinib (Tukysa®) after surgery.
Who is this for?
People with stage II or stage III HER2-positive breast cancer who received chemotherapy and trastuzumab (or pertuzumab and margetuximab) before surgery. During your surgery, leftover tumor must have been found in your breast or lymph node (residual disease).
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups and receive the following for up to 10 months: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, twice daily, </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, twice daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is an anti-HER2-targeted therapy approved for use with specific other therapies. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody -— the HER2-targeted therapy trastuzumab (Herceptin®) -- to directly deliver the chemotherapy DM1 to the cancer cells. It is approved for use in people who had some leftover tumor (residual disease) after receiving neoadjuvant (before surgery) therapies, but its use in this trial is considered experimental.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04457596' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/residual-disease' target='_blank'>NCI Dictionary of Cancer Terms: Residual Disease</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/kadcyla-fda-breast-her2-adjuvant' target='_blank'>NCI Cancer Currents Blog: T-DM1 Approval Expanded to Include Some Women with Early-Stage HER2-Positive Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Kadcyla (Trastuzumab emtansine/T-DM1)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/druglist/tukysa' target='_blank'>Breastcancer.org: Tukysa (Tucatinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/personalizing-her2-targeted-treatment-strategies-in-early-stage-and-advanced-breast-cancer' target='_blank'>OncLive: Personalizing HER2-Targeted Treatment Strategies in Early-Stage and Advanced Breast Cancer</a> </li></ul>
2
NEAREST SITE: 3 miles
Sutter Cancer Research Consortium
San Francisco,CA
VISITS: Coincides with targeted therapy
PHASE: II
NCT ID: NCT02693535
Choosing Targeted Therapy Based on a Tumor's Genetic Makeup for Advanced Breast Cancer (TAPUR)
A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of using a tumor's genetic profile to select an FDA-approved targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer with no standard treatment options. You must have results from a genomic or immunohistochemistry test approved by TAPUR.
Full eligibility criteria
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<p class="seamTextPara"> You will receive an FDA-approved targeted therapy based on your tumor's genetic profile.</p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy you receive will be selected based on your tumor's genetic profile.</li> <li class="seamTextUnorderedListItem">Your treatment may include one or more of the following: Abemaciclib, Futibatinib, Nivolumab, Ipilimumab, Olaparib, Palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, Trastuzumab, Pertuzumab, Vemurafenib, Cobimetinib</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ALK, ATM, BRAF, BRAF V600E/D/K/R, BRCA1/2, CDK4, CDK6, CDKN2A, CSF1R, FGFR1/2/3/4, HER2 (ERBB2), high mutational load and others, KIT, MET, MSI-H, mTOR, NRG1, PALB2, PDGFR, POLD1, POLE, RAF-1, RET, ROS1, TSC, VEGFR</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02693535' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.tapur.org/' target='_blank'>ASCO: TAPUR Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/clinical-trials/what-tapur-study' target='_blank'>Cancer.Net (Video): What is the TAPUR Study?</a> </li><li class='seamTextUnorderedListItem'><a href='https://old-prod.asco.org/research-data/tapur-study/study-participation' target='_blank'>ASCO: TAPUR Study Participation</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/conference-coverage/asco-2016/dr-edward-kim-on-ascos-tapur-trial' target='_blank'>OncLive (Video): About TAPUR</a> </li></ul>
3
NEAREST SITE: 3 miles
Research Site
San Francisco,CA
VISITS: 1 visit every month, ongoing
PHASE: II
NCT ID: NCT04829604
Antibody-Drug Conjugate ARX788 for Metastatic HER2 Positive Breast Cancer
A Global, Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM-1 or T-DXd, and/or Tucatinib-containing Regimens Scientific Title
Purpose
To study the safety, anti-cancer activity, and side effects of the investigational antibody-drug conjugate ARX788.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who have already received tucatinib (Tukysa®), T-DM1 (Kadcyla®), or trastuzumab deruxtecan (Enhertu®) in the metastatic setting.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARX788, by IV, once a month, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibody-drug conjugates (ADCs) are therapies that contain an antibody linked to a specific type of chemotherapy. They are designed to deliver high doses of chemotherapy to cancer cells while sparing normal cells. </li> <li class="seamTextUnorderedListItem">ARX788 is an investigational antibody-drug conjugate -- this means it is only available in clinical trials. </li> <li class="seamTextUnorderedListItem">ARX788 targets HER2 to deliver the chemotherapy AS269 directly to cancer cells.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04829604' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Getting to the Target, Antibody Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/fda-grants-fast-track-status-to-adc-arx788-for-her2-metastatic-breast-cancer' target='_blank'>OncLive: FDA Grants Fast Track Status to ADC ARX788 for HER2+ Metastatic Breast Cancer</a> </li></ul>
4
NEAREST SITE: 3 miles
University of California San Francisco (UCSF)
San Francisco,CA
VISITS: 1 visit every week for 3-6 months
PHASE: II
NCT ID: NCT01042379
I-SPY 2: Personalized Treatment Before Surgery for Stage II-III Breast Cancer
I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of standard of care therapy compared to standard of care therapy with an experimental drug chosen based on your tumor's biomarkers.
Who is this for?
People with stage II or stage III breast cancer who have not yet received treatment and whose cancer is high-risk for recurrence.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups and receive the following before surgery: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> <li class="seamTextUnorderedListItem">At least 1 experimental therapy chosen based on your tumor's biomarkers</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">4 MRIs</li> <li class="seamTextUnorderedListItem">2 biopsies</li> <li class="seamTextUnorderedListItem">Blood draws</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy is treatment specific to an individual's tumor type, which are called biomarkers.</li> <li class="seamTextUnorderedListItem">This clinical trial has an adaptive design. This means that experimental drugs will be added during the trial, and experimental drugs that are not more effective than standard of care therapy will be removed.</li> <li class="seamTextUnorderedListItem">At least 80% of people who enroll will receive an experimental drug.</li> <li class="seamTextUnorderedListItem">All drugs will be given before surgery (neoadjuvant therapy). This allows researchers to see how your tumor is responding to the drugs.</li> <li class="seamTextUnorderedListItem">For this trial, cancer is considered high-risk for recurrence if it tests MammaPrint Low (only if your tumor is ER- or ER+, HER2+) or MammaPrint High.</li> <li class="seamTextUnorderedListItem">MammaPrint is a genomic test that identifies genes in your tumor and gives two types of recurrence risk scores: low risk or high risk.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01042379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ispypatient.org/' target='_blank'>Quantum Leap Healthcare Collaborative: I-SPY Patient Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/32701140/' target='_blank'>Journal Article: Three-Year Follow-Up Analysis for the I-SPY 2 Adaptively Randomized Clinical Trial</a> </li></ul>
5
NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA
VISITS: 1 visit every 3 weeks, for 1 year
PHASE: II
NCT ID: NCT04893109
Trastuzumab by Injection with Chemotherapy or an Antibody-Drug Conjugate for Stage I HER2 Positive Breast Cancer
A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab Versus Paclitaxel in Combination With Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0) Scientific Title
Purpose
To study and compare the safety, side effects, and anti-cancer activity of giving Herceptin Hylecta (trastuzumab by injection) with chemotherapy to giving it with an antibody-drug conjugate.
Who is this for?
People with stage I HER2-positive (HER2+) breast cancer who have already had surgery and completed radiation therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, for 4.5 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®)/Herceptin Hylecta, by injection, every 3 weeks, for 7.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week, for 3 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®)/Herceptin Hylecta, by injection, every 3 weeks, for 11.5 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody -— the HER2-targeted therapy trastuzumab (Herceptin®) -— to deliver the chemotherapy DM1 directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2 positive breast cancer. </li> <li class="seamTextUnorderedListItem">Herceptin Hylecta is a form of trastuzumab that is given by injection instead of by IV. </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04893109' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-new-formulation-herceptin-subcutaneous-use' target='_blank'>FDA Drug Approvals and Database: FDA Approves New Formulation of Herceptin for subcutaneous Use</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab Emtansine/T-DM1 (Kadcyla®)</a> </li></ul>
6
NEAREST SITE: 3 miles
Kaiser Permanente-San Francisco
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT05705401
Anti-HER2 Targeted Therapy With or Without Radiation for Women with DCIS and Stage I-III HER2 Positive Breast Cancer
A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of standard of care anti-HER2 targeted therapy with and without adjuvant (after surgery) radiation.
Who is this for?
People at least 40 years old with stage 0 (DCIS), stage I, stage II, or some stage III HER2 positive (HER2+) breast cancer who have received a lumpectomy, chemotherapy, and anti-HER2 targeted therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care With Radiation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue standard of care anti-HER2 targeted therapy</li> <li class="seamTextUnorderedListItem">Radiation</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care Without Radiation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue standard of care anti-HER2 targeted therapy</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Due to the low risk of recurrence (cancer coming back) of people in this trial, researchers think there may be a low benefit of radiation in addition to anti-HER2 targeted therapy after surgery.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), trastuzumab (Herceptin®), and pertuzumab (Perjeta®) are examples of anti-HER2 targeted therapies used to treat HER2 positive (HER2+) breast cancer.</li> <li class="seamTextUnorderedListItem">A lumpectomy is sometimes called a partial mastectomy.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05705401' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-anti-her2-therapies' target='_blank'>Breastcancer.org: Anti-HER2 Targeted Therapy</a> </li></ul>
7
NEAREST SITE: 3 miles
University of California San Francisco Medical Center
San Francisco,CA
VISITS: 1 visit every 3 weeks
PHASE: I
NCT ID: NCT04042701
Trastuzumab Deruxtecan ADC and Pembrolizumab Immunotherapy for Advanced HER2 Positive and HER2 Low Breast Cancer
A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, In Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC) Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of trastuzumab deruxtecan (Enhertu®) antibody drug conjugate (ADC) with pembrolizumab (Keytruda®) PD-1 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who have received trastuzumab emtansine/T-DM1 (Kadcyla®) or standard of care therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy directly to the cancer cells. It is approved for use to treat people with metastatic HER2+ breast cancer who have already received two anti-HER2 therapies. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking PD-1 allows the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of solid tumors.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04042701' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2-positive-breast-cancer' target='_blank'>FDA: FDA Approves Fam-Trastuzumab Deruxtecan-nxki</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/fam-trastuzumab-deruxtecan' target='_blank'>NCI Drug Dictionary: Fam-Trastuzumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/news/february-2020/trastuzumab-deruxtecan-in-her2-low-expressing-previously-treated-advanced-breast-cancer/' target='_blank'>ASCO Post: Trastuzumab Deruxtecan in HER2–Low-Expressing, Previously Treated Advanced Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda)</a> </li></ul>
8
NEAREST SITE: 28 miles
Stanford University
Palo Alto,CA
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT04278144
BDC-1001 With or Without Keytruda for People With Advanced HER2 Positive Breast Cancer
Phase 1 Study of BDC-1001 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced and HER2-Expressing Solid Tumors Scientific Title
Purpose
To study the anti-cancer activity and effects (good and bad) of giving the new immunotherapy drug BDC-1001 alone and with the PD-1 inhibitor pembrolizumab (Keytruda®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have no other treatment options available.
Full eligibility criteria
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<p class="seamTextPara"> This is a 2-part study. Depending upon which part of the trial is open when you enroll, you will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001 is an investigational drug called an Immune Stimulating Antibody Conjugate. It combines an anti-HER2 drug with a drug that targets the TLR7/8 proteins. </li> <li class="seamTextUnorderedListItem">Researchers think targeting the TLR7/8 proteins can help make tumors more likely to respond to pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Pembrolizumab is another type of immunotherapy called a PD-1 inhibitor. It works by getting the immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04278144' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://boltbio.com/#ourscience' target='_blank'>Drug Company Information Page: BDC-1001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytru' target='_blank'>Merck Oncology: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nationalbreastcancer.org/breast-cancer-targeted-therapy' target='_blank'>National Breast Cancer Foundation: Targeted Therapy (Monoclonal Antibodies)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Immune_stimulating_antibody_conjugate' target='_blank'>Wikipedia: Immune Stimulating Antibody Conjugate</a> </li></ul>
9
NEAREST SITE: 47 miles
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville,CA
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT04266249
Neoadjuvant (Before Surgery) Chemotherapy and Targeted Therapies for Stage II-III, HER2+ Breast Cancer
(CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response (EA1181) Scientific Title
Purpose
To determine if chemotherapy after surgery can be avoided for people who have no tumor remaining after receiving chemotherapy and targeted therapy before surgery.
Who is this for?
People with stage II or stage III, HER2 positive (HER2+) breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> Before surgery, you will receive the following, for 3 months: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, either once a week or every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every week (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, once every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Followed by surgery (lumpectomy or mastectomy)</i> </p> <p class="seamTextPara"> After surgery, you will be assigned to 1 of 2 groups depending upon if you had any tumor remaining: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: No tumor remaining</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, once every 3 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Pertuzumab, (Perjeta®), by IV, once every 3 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Radiation therapy and/or hormone therapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Tumor remaining</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, for 10 months</li> <li class="seamTextUnorderedListItem">Radiation therapy, hormone therapy and/or chemotherapy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant chemotherapy and targeted therapy (treatment given before surgery) is used to shrink tumors.</li> <li class="seamTextUnorderedListItem">Sometimes the tumor will disappear completely and sometimes there will still be some tumor remaining at the time of surgery. </li> <li class="seamTextUnorderedListItem">Your doctor will decide which neoadjuvant chemotherapy to give you: docetaxel (Taxotere®), nab-paclitaxel (Abraxane®), or paclitaxel (Taxol®). </li> <li class="seamTextUnorderedListItem">Everyone will receive the same anti-HER2 targeted therapies of trastuzumab (Herceptin®) and pertuzumab (Perjeta®).</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04266249' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ecog-acrin.org/clinical-trials/ea1181-educational-materials' target='_blank'>Cancer Research Group: CompassHER2 Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healthline.com/health/breast-cancer/chemotherapy-for-her2-positive-breast-cancer#chemotherapy-side-effects' target='_blank'>Healthline: Chemotherapy and Targeted Therapy for HER2-Positive Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/diagnosis/her2' target='_blank'>Breastcancer.org: HER2 Status</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hematologyandoncology.net/archives/may-2019/how-we-treat-locally-advanced-her2-positive-breast-cancer/' target='_blank'>Clinical Advances in Hematology & Oncology: How We Treat Locally Advanced HER2-Positive Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://esmoopen.bmj.com/content/4/3/e000515' target='_blank'>Journal Article: Neoadjuvant Treatment for Intermediate/High-Risk HER2 Positive and Triple Negative Breast Cancers</a> </li></ul>
10
NEAREST SITE: 158 miles
California Cancer Associate for Research & Excellence
Fresno,CA
VISITS: 1 visit every 3 weeks, for 10 months
PHASE: III
NCT ID: NCT04873362
Additional Treatment for People with Stage I-III HER2+ Breast Cancer Who had Tumor Remaining after Receiving Treatment Before Surgery
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy Scientific Title
Purpose
To study and compare the anti-cancer activity, side effects, and safety of giving trastuzumab emtansine (Kadcyla®) alone or with atezolizumab (Tecentriq®) after neoadjuvant therapy and surgery.
Who is this for?
People with stage I, stage II, or stage III HER2 positive (HER2+) breast cancer who received chemotherapy and an anti-HER2 targeted therapy before surgery (neoadjuvant treatment). During surgery, your doctors must have found remaining tumor or cancer cells in your breast or lymph nodes (residual disease). Additionally, you must not have already received trastuzumab emtansine, atezolizumab, or any other checkpoint inhibitor.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, for 10 months</li> <li class="seamTextUnorderedListItem">Placebo for atezolizumab (Tecentriq®), by IV, every 3 weeks, for 10 months. </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, for 10 months</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, for 10 months.</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like chemotherapy or targeted therapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies. </li> <li class="seamTextUnorderedListItem">Residual disease is when, during surgery, doctors find some remaining tumor in the breast or lymph nodes of a person who received neoadjuvant therapy. </li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody — the HER2-targeted therapy trastuzumab — to deliver the chemotherapy DM1 directly to cancer cells.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor or a checkpoint inhibitor.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04873362' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab Emtansine (Kadcyla®)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/atezolizumab.aspx' target='_blank'>Chemocare: Atezolizumab (Tecentriq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/january-25-2020/residual-cancer-burden-is-prognostic-of-outcomes-across-breast-cancer-subtypes/' target='_blank'>The ASCO Post: Residual Cancer Burden Is Prognostic of Outcomes Across Breast Cancer Subtypes</a> </li></ul>
11
NEAREST SITE: 336 miles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles,CA
VISITS: 1 visit every week
PHASE: I-II
NCT ID: NCT05319873
Targeted Therapy for HER2 Positive Stage II-IV Breast Cancer
A Phase 1B Trial Evaluating the Safety of Ribociclib, Tucatinib, and Trastuzumab in Patients With Metastatic, HER2+ Breast Cancer and a Multicenter, Randomized, Open-Label, Phase 2 Study of Preoperative Treatment With Ribociclib,Ttrastuzumab, Tucatinib, and Fulvestrant Versus Docetaxel, Carboplatin,Ttrastuzumab, and Pertuzumab in HR+/HER2+ Breas... Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ribociclib (Kisqali®), trastuzumab (Herceptin®), and tucatinib (Tukysa®) targeted therapies alone or with fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with stage II, stage III, or stage IV (metastatic) HER2 positive (HER2+) or HER2 low breast cancer. If you have stage II or some stage III breast cancer, you must not have received treatment or surgery. If you have advanced (some stage III) or metastatic (stage IV) breast cancer, you must have received at least 1 line of anti-HER2 targeted therapy for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on your type of cancer: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. It blocks two enzymes, CDK 4 and CDK 6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05319873' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
12
NEAREST SITE: 336 miles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles,CA
VISITS: 1 visit every 3 weeks
PHASE: II
NCT ID: NCT04553770
Trastuzumab Deruxtecan Alone or With Hormone Therapy for Stage II-III HER2 Low, HR Positive Breast Cancer
A Phase II, Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan (DS-8201a) With or Without Anastrozole for HER2 Low Hormone Receptor Positive (HR+) Breast Cancer in the Neoadjuvant Setting Scientific Title
Purpose
To study and compare the anti-cancer acitivity and safety of giving trastuzumab deruxtecan-nxki (Enhertu®) alone or with the anti-estrogen therapy anastrozole (Arimidex®) before surgery (neoadjuvant).
Who is this for?
People with stage II or stage III hormone positive (ER+ and/or PR+), HER2 low expression (defined below) breast cancer whose tumor is 2 cm or larger and who have not yet started treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups and recieve the following before surgery: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, over 4.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, over 4.5 months</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily, for 4.5 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC). It uses a HER2 antibody to deliver a chemotherapy directly to cancer cells.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®) is type of anti-estrogen therapy called an aromatase inhibitor. It is commonly used to treat early stage and metastatic hormone positive (ER+ and/or PR+) breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04553770' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Trastuzumab_deruxtecan' target='_blank'>Wikipedia: Trastuzumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.enhertuhcp.com/en/?utm_source=google&utm_medium=cpc&utm_campaign=branded+general_2020%3bs%3bph%3bbr%3bonc%3bhcp%3bbr&utm_content=branded+general_2020_exact&utm_term=enhertu&gclid=cj0kcqia48j9brc-arisamqu3wqel0xz_rkoi7g8nk-ckknd1pfqh_i4wknawmwg' target='_blank'>Daiichi-Sankyo Drug Information Page: Enhertu®</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/her2-low-expressing-a-new-subcategory-of-her2-negative-breast-cancer/' target='_blank'>Metastatic Trial Talk: HER2-Low Expressing, A New Subcategory of HER2 Negative Breast Cancer?</a> </li></ul>
13
NEAREST SITE: 339 miles
UCLA Department of Medicine - Hematology & Oncology
Santa Monica,CA
VISITS: 1 visit every 3 weeks
PHASE: III
NCT ID: NCT05132582
Tucatinib, Trastuzumab, and Pertuzumab Targeted Therapies for Advanced HER2+ Breast Cancer (HER2CLIMB-05)
A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of tucatinib (Tukysa®), trastuzumab (Herceptin®) , and pertuzumab (Perjeta®) anti-HER2 targeted therapies compared to trastuzumab (Herceptin®) and pertuzumab (Perjeta®) alone.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer with and without evidence of disease. You must be receiving or have received treatment with trastuzumab (Herceptin®), pertuzumab (Herceptin®), and a taxane chemotherapy for advanced/metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV or injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for tucatinib (Tukysa®), by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV or injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imaging scans, every 2 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), trastuzumab (Herceptin®), and pertuzumab (Perjeta®) are anti-HER2 targeted therapies used to treat HER2 positive (HER2+) breast cancer.</li> <li class="seamTextUnorderedListItem">The placebo is a pill that looks the same as tucatinib (Tukysa®) but does not contain the medication.</li> <li class="seamTextUnorderedListItem">Some blood tests may be completed locally instead of at the trial research site.</li> <li class="seamTextUnorderedListItem">The imaging scan costs are covered by the clinical trial.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05132582' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.her2climb05.com/' target='_blank'>Seagen: Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/perjeta' target='_blank'>Breastcancer.org: Pertuzumab (Perjeta®)</a> </li></ul>
14
NEAREST SITE: 341 miles
Lawrence J. Ellison Institute for Transformative Medicine
Los Angeles,CA
VISITS: 1 visit every 3 weeks
PHASE: III
NCT ID: NCT05894239
Inavolisib and Phesgo for Advanced HER2 Positive Breast Cancer with a PIK3CA Mutation
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer... Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of inavolisib, an experimental PI3K inhibitor, with Phesgo anti-HER2 targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer with a PIK3CA mutation who have not received treatment for advanced disease (except for hormone therapy if HR+).
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy (optional, if relevant)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for inavolisib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy (optional, if relevant)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will first receive induction therapy (initial therapy used when treating a disease) with Phesgo and chemotherapy.</li> <li class="seamTextUnorderedListItem">Inavolisib is an experimental targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Phesgo is a combination of two anti-HER2 targeted therapies: Perjeta® (pertuzumab) and Herceptin® (trastuzumab). It also includes a protein called hyaluronidase which helps your body absorb the targeted therapies.</li> <li class="seamTextUnorderedListItem">Pertuzumab and trastuzumab are typically given by IV. With Phesgo, you can receive these therapies by injection, which shortens the length of time it takes to receive treatment.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05894239' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/medical-professionals/pipeline/inavolisib-gdc-0077' target='_blank'>Genentech: Inavolisib Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/phesgo' target='_blank'>Breastcancer.org: Phesgo</a> </li></ul>
15
NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA
VISITS: 1 visit every 1-2 months
PHASE: III-IV
NCT ID: NCT05376878
PET/MRI Scan to Determine Response to Treatment for People with Metastatic HER2+ Breast Cancer with Brain or Leptomeninges Metastasis
Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan Scientific Title
Purpose
To find HER2+ breast cancer that has spread to the brain and predict response to treatment with trastuzumab deruxtecan (Enhertu®), an antibody drug conjugate (ADC).
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain or leptomeninges (brain or leptomeningeal metastasis) who are planning to receive treatment with trastuzumab deruxtecan (Enhertu®).
Full eligibility criteria
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- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">64Cu-DOTA-trastuzumab, by IV, 1 time</li> <li class="seamTextUnorderedListItem">PET/MRI scan, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI scan, every 1.5 months for 6 months, then every 2 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">64Cu-DOTA-trastuzumab is an experimental tracer that detects cancer cells during imaging scans.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive tracer to look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy.</li> <li class="seamTextUnorderedListItem">The results of your PET/MRI scan will find the cancer in your brain and may predict your response to treatment.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a type of anti-HER2 targeted therapy used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05376878' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cedars-sinai.org/programs/imaging-center/exams/nuclear-medicine/pet-mri.html' target='_blank'>Cedars-Sinai: PET/MRI Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab deruxtecan (Enhertu®)</a> </li></ul>
16
NEAREST SITE: 362 miles
Innovative Clinical Research Institute
Whittier,CA
VISITS: 1 visit every 3 weeks
PHASE: I
NCT ID: NCT05593094
ZN-A-1041 Targeted Therapy for Advanced HER2 Positive or HER2 Low Breast Cancer
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid Tumors Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ZN-A-1041, an experimental anti-HER2 targeted therapy, with other anti-HER2 targeted therapies.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low (IHC 2+) breast cancer who have no standard treatment options available. You must have received treatment with trastuzumab (Herceptin®) and chemotherapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-A-1041, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-A-1041, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-Dxd), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-A-1041, by mouth, daily</li> <li class="seamTextUnorderedListItem">Pertuzumab/trastuzumab (PHESGO®), by injection, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-A-1041 is an experimental anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®) and trastuzumab deruxtecan (T-Dxd, Enhertu®) are antibody drug conjugates (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine and trastuzumab deruxtecan target HER2 and deliver anti-cancer drugs.</li> <li class="seamTextUnorderedListItem">Pertuzumab/trastuzumab (PHESGO®) is a combination of two anti-HER2 targeted therapies, pertuzumab (Perjeta®) and trastuzumab (Herceptin®). You may also receive the two drugs separately.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05593094' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.businesswire.com/news/home/20200907005109/en/Zion-Pharma-Announces-Initiation-of-Phase-1-Study' target='_blank'>Zion Pharma Press Release: ZN-A-1041</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab emtansine (T-DM1, Kadcyla®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab deruxtecan (T-Dxd, Enhertu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/phesgo' target='_blank'>Breastcancer.org: Pertuzumab/trastuzumab (PHESGO®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-anti-her2-therapies' target='_blank'>Breastcancer.org: Anti-HER2 Targeted Therapy</a> </li></ul>
17
NEAREST SITE: 366 miles
Cancer and Blood Specialty Clinic
Los Alamitos,CA
VISITS: 1 visit every 3 weeks
PHASE: II
NCT ID: NCT06188559
BB-1701 Antibody Drug Conjugate for Advanced HER2+ or HER2 Low Breast Cancer
An Open-label, Multicenter, Phase 2 Dose Optimization and Expansion Study to Evaluate the Safety and Efficacy of BB-1701, an Anti-human Epidermal Growth Factor Receptor 2 (Anti-HER2) Antibody-drug Conjugate (ADC), in Previously Treated Subjects With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of BB-1701, an experimental antibody drug conjugate (ADC).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who have received trastuzumab deruxtecan (Enhertu®). You must have received 1-3 lines of chemotherapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BB-1701, by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BB-1701 is an experimental targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">BB-1701's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called eribulin.</li> <li class="seamTextUnorderedListItem">In this trial, HER2+ is defined as IHC 3+ or IHC 2+/ISH+.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/ISH -.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06188559' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.blissbiopharma.com/Innovation?_l=en#Pipeline' target='_blank'>Eisai/Bliss Biopharmaceutical: BB-1701 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
18
NEAREST SITE: 383 miles
Arrowhead Regional Medical Center
Colton,CA
VISITS: About 1 visit a week for 5 to 6 months
PHASE: II
NCT ID: NCT03412643
Chemotherapy and HER2-Targeted Therapies Before Surgery for Stage I-III, HER2 Negative Breast Cancer That Shows Other HER2 Activity
An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected With a Test Measuring Live Cell HER2 Signaling Transduction (FACT 1) Scientific Title
Purpose
To study the effects (good and bad) of chemotherapy combined with the anti-HER2 targeted therapies trastuzumab (Herceptin®) and pertuzumab (Perjeta®) on HER2 negative (HER2-) cancer cells that test positive for other types of HER2 activity.
Who is this for?
Women with stage II or stage III HER2 negative (HER2-) breast cancer whose cancer has HER2 activity based on the Celcuity CELx HER2 (HSF) test and who have not yet started treatment for breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following before surgery over 5-6 months: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®), by IV, every 2 or 3 weeks, for 2-3 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">followed by</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks, for 2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 biopsy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies commonly used to treat HER2 positive (HER2+) breast cancer. </li> <li class="seamTextUnorderedListItem">They are not approved for use on HER2 negative (HER2-) breast cancer. Their use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">The Celcuity CELx HER2 Signaling Function (HSF) test checks breast cancer cells for activity called abnormal HER2 signaling. </li> <li class="seamTextUnorderedListItem">To be eligible for this trial, your cancer cells must test positive for abnormal HER2 signaling.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03412643' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/TumorCharacteristics.html' target='_blank'>Susan G. Komen: Tumor Characteristics</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies' target='_blank'>Breastcancer.org: Targeted Therapies</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/32036454' target='_blank'>Journal Abstract: New HER2 Negative Breast Cancer Subtype Responsive to Anti-HER2 Therapy Identified</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncotarget.com/article/12480/text/' target='_blank'>Journal Article: HER2 Signaling Activity Test</a> </li></ul>
19
NEAREST SITE: 386 miles
City of Hope
Irvine,CA
VISITS: 1 visit every 1-2 weeks for 2 years
PHASE: II
NCT ID: NCT05954143
BDC-1001 ADC for Metastatic HER2 Positive or HER2 Amplified Breast Cancer
Phase 2, Multi-Center, Randomized, Open-Label Trial of BDC-1001 as a Single Agent and in Combination With Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab Deruxtecan Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of BDC-1001, an experimental antibody-drug conjugate (ADC), alone or with pertuzumab (Perjeta®) anti-HER2 targeted therapy.
Who is this for?
People with stage IV (metastatic) HER2 positive (HER2+) or HER2 amplified breast cancer who have received 2 lines of anti-HER2 targeted therapy including trastuzumab deruxtecan (Enhertu®).
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001, by IV, every 2 weeks for 2 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001, by IV, every 2 weeks for 2 years</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks for 2 years</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001 is an experimental antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">BDC-1001's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) is an anti-HER2 targeted therapy commonly used to treat HER2 positive breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05954143' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.boltbio.com/pipeline-new/#bdc-1001' target='_blank'>Bolt Biotherapeutics: BDC-1001 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
20
NEAREST SITE: 538 miles
Providence Cancer Institute
Portland,OR
VISITS: Approximately 1 visit every 3 weeks
PHASE: II
NCT ID: NCT05163223
AST-301 Vaccine After Surgery for Stage I-III HR-, HER2 Low Breast Cancer
A Phase 2 Study to Evaluate the Efficacy and Safety of an Adjuvant Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Low Breast Cancer (Cornerstone-001) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of AST-301, an experimental adjuvant (after surgery) vaccine.
Who is this for?
People with stage I, stage II, or stage III hormone receptor negative (ER- and/or PR-), HER2 low breast cancer with residual disease after neoadjuvant (before surgery) treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AST-301, by injection, every 3 weeks for 9 weeks plus a booster 6 months later</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks or capecitabine (Xeloda®), by mouth, 2 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for AST-301, by injection, every 3 weeks for 9 weeks plus a booster 6 months later</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks or capecitabine (Xeloda®), by mouth, 2 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AST-301 is an experimental vaccine that may stimulate the immune system to attack and kill cancer cells that express HER2.</li> <li class="seamTextUnorderedListItem">AST-301 and the placebo for AST-301 include sargramostim (Leukine®) which helps the vaccine work better.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells that are present after treatment.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+ and ISH-.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05163223' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pngvl3-hicd-vaccine-ast-301' target='_blank'>National Cancer Institute: AST-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/search?search=capecitabine' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/novel-her2-hicd-vaccine-to-be-investigated-for-treatment-of-her2-low-breast-cancer' target='_blank'>Targeted Oncology: Novel Vaccine to be Investigated for Treatment of HER2 Low Breast Cancer</a> </li></ul>
21
NEAREST SITE: 538 miles
Providence Portland Medical Center
Portland,OR
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05323955
Adding Tucatinib Targeted Therapy to Standard of Care Therapy for Metastatic HER2+ Breast Cancer with Brain Metastases
Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib (BRIDGET) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of adding tucatinib (Tukysa®) tyrosine kinase inhibitor to standard of care trastuzumab (Herceptin®) or pertuzumab (Perjeta®) anti-HER2 targeted therapy or trastuzumab emtansine (Kadcyla®, T-DM1) antibody drug conjugate.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain (brain metastasis) who are receiving their first line of metastatic treatment with trastuzumab (Herceptin®) or pertuzumab (Perjeta®) or second line of metastatic treatment with trastuzumab emtansine (Kadcyla®, T-DM1). You must not have received whole brain radiation therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue standard of care trastuzumab (Herceptin®), pertuzumab (Perjeta®), or trastuzumab emtansine (Kadcyla®, T-DM1)</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (Kadcyla®, T-DM1) is an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An ADC is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (Kadcyla®, T-DM1)'s antibody targets HER2 and delivers an anti-cancer drug called emtansine.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are anti-HER2 targeted therapies used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme that helps cancer cells grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05323955' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/featured-clinical-trials/#toggle-id-1' target='_blank'>MBCBrainMets.org: BRIDGET Trial Video with Dr. Sarah Sammons</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab Emtansine (Kadcyla®, T-DM1)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/perjeta' target='_blank'>Breastcancer.org: Pertuzumab (Perjeta®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li></ul>
22
NEAREST SITE: 602 miles
University of Utah
Salt Lake City,UT
VISITS: At least 1 visit every 3 weeks
PHASE: I
NCT ID: NCT05765851
DS-1103a Targeted Therapy with ADC for Advanced HER2 Low Breast Cancer
A Phase 1, 2-Part, Multicenter, First-In-Human Dose-Escalation and Dose-Expansion Study of DS-1103a Combination Therapy in Subjects With Advanced Solid Tumors Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of DS-1103a, an experimental SIRPa inhibitor, alone or with trastuzumab deruxtecan (Enhertu®) antibody drug conjugate (ADC).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 low breast cancer who have received up to 2 lines of chemotherapy for advanced disease. You must not have received anti-HER2 targeted therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-1103a, by IV</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-1103a is an experimental targeted therapy called a SIRPa inhibitor. Inhibiting SIRPa may stimulate the immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/ISH-.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05765851' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.daiichisankyo.com/rd/pipeline/' target='_blank'>Daiichi Sankyo: Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (Enhertu®)</a> </li></ul>
23
NEAREST SITE: 679 miles
Swedish Cancer Institute
Issaquah,WA
VISITS: 1 visit every 1-2 weeks
PHASE: II
NCT ID: NCT05458674
Targeted Therapy and Chemotherapy for Advanced HER2+ Breast Cancer
A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination With Eribulin and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of trastuzumab (Herceptin®) anti-HER2 targeted therapy, tucatinib (Tukysa®) tyrosine kinase inhibitor, and eribulin (Halaven®) chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received treatment with trastuzumab (Herceptin®) and chemotherapy for advanced/metastatic disease.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug approved to treat metastatic breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05458674' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/halaven' target='_blank'>Breastcancer.org: Eribulin (Halaven®)</a> </li></ul>
24
NEAREST SITE: 682 miles
University of Washington Fred Hutchinson Cancer Care
Seattle,WA
VISITS: 1 visit every week for 3 months
PHASE: II
NCT ID: NCT04425018
Chemo and Anti-HER2 Therapy Before Surgery for Stage II-III HER2 Positive Breast Cancer
MARGetuximab Or Trastuzumab (MARGOT): A Phase II Study Comparing Neoadjuvant Paclitaxel/Margetuximab/Pertuzumab to Paclitaxel/Trastuzumab/Pertuzumab in Patients With Stage II-III HER2-positive Breast Cancer Scientific Title
Purpose
To study and compare the anti-cancer activity, safety and side effects of giving paclitaxel (Taxol®) and pertuzumab (Perjeta®) with the anti-HER2 therapy margetuximab (Margenza®) or with trastuzumab (Herceptin®) before surgery.
Who is this for?
People with stage II or stage III, HER2 positive (HER2+) breast cancer who have a tumor that is at least 1.5 cm and who have not yet had surgery.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups, and receive the following for 3 months before surgery: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) by IV, once every week</li> <li class="seamTextUnorderedListItem">Margetuximab (Margenza®) by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) by IV, once every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) by IV, once every week</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) by IV, once every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 biopsies</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">All therapies will be given before surgery (neoadjuvant therapy), this allows researchers to see how your tumor is responding.</li> <li class="seamTextUnorderedListItem">Margetuximab (Margenza®) has been approved for use in metastatic HER2 positive breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are anti-HER2 targeted therapies commonly used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Your tumor must test positive for a CD16 inherited genotype of FF or FV.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04425018' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/clinical-trials2/detail/20-068/' target='_blank'>Dana-Farber Cancer Institute: Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.macrogenics.com/margetuximab-anti-her2/' target='_blank'>MacroGenics Drug Information Page: Margetuximab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/trastuzumab' target='_blank'>NCI Drug Dictionary: Trastuzumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/perjeta' target='_blank'>Breastcancer.org: Perjeta® (Pertuzumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: Targeted Drug Therapy for HER2 Positive Breast Cancer</a> </li></ul>
25
NEAREST SITE: 682 miles
University of Washington-
Seattle,WA
VISITS: 1 visit every 3 weeks, ongoing
PHASE: I-II
NCT ID: NCT03368729
Niraparib and Herceptin in Women With Metastatic HER2+ Breast Cancer
A Phase 1b/2 Study of the PARP Inhibitor Niraparib in Combination With Trastuzumab in Patients With Metastatic HER2+ Breast Cancer Scientific Title
Purpose
To look at the safety, effects (good and bad), and anti-cancer activity of combining niraparib (Zejula®) with trastuzumab (Herceptin®).
Who is this for?
Women with metastatic (stage IV) HER2 positive (HER2+) breast cancer who have already been treated with a HER2 targeted therapy, have not been treated with a PARP inhibitor, and do not have a hereditary BRCA1/2 mutation.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zejula is at type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA. It is approved to treat women with certain types of reproductive cancers. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Herceptin is a HER2-targeted therapy approved to treat HER2 positive breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03368729' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zejula.com/en' target='_blank'>Drug Company Information Page: Zejula® (Niraparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/herceptin?gclid=Cj0KCQiAyKrxBRDHARIsAKCzn8zEHqEyTfwjNEW138WZ4GeUdB3CVmQfk-GJ5zPldOhQ2p6lEMBu1fsaAt6rEALw_wcB' target='_blank'>Breastcancer.org: Herceptin</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-breast-cancer-treatment/parp-inhibitors-in-breast-cancer-treatment' target='_blank'>Breast Cancer Now: PARP Inhibitors in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedaily.com/releases/2012/09/120917084946.htm' target='_blank'>ScienceDaily: PARP Inhibitors May Have Clinical Utility in HER2-positive Breast Cancers</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/25128455' target='_blank'>PubMed Abstract: Poly (ADP-ribose) Polymerase Inhibition Enhances Trastuzumab Antitumour Activity in HER2 Overexpressing Breast Cancer.</a> </li></ul>
26
NEAREST SITE: 682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle,WA
VISITS: 1 or 2 visits a week, for 3 months before surgery
PHASE: II
NCT ID: NCT04329065
WOKVAC Vaccine with Chemotherapy and Two Anti-HER2 Targeted Therapies Before Surgery for Stage I-III, HER2 Positive, HR Negative Breast Cancer
A Phase II Study of Concurrent WOKVAC Vaccination With Neoadjuvant Chemotherapy and HER2-Targeted Monoclonal Antibody Therapy Scientific Title
Purpose
To study the anti-cancer activity, safety and side effects of giving the WOKVAC vaccine in combination with the chemotherapy paclitaxel (Taxol®) and the anti-HER2 targeted therapies trastuzumab (Herceptin®) and pertuzumab (Perjeta®) before surgery.
Who is this for?
People with stage I, stage II or stage III, HER2 positive (HER2+), hormone negative (ER- and PR-) breast cancer who have not yet had surgery. If you have already started chemotherapy before surgery, you will be allowed to enroll but will not receive the vaccine.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following for three months before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">WOKVAC vaccine, by injection, 3 times</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week (2 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pertuzumab, (Perjeta®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">WOKVAC is an experimental vaccine designed to stimulate your immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are HER2-targeted therapies used to treat HER2 positive (HER2+) breast cancer.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) is approved to treat early-stage HER2 positive breast cancer with tumors 2 cm or larger or with positive lymph nodes. It's use in this trial may be considered experimental depending upon the size of your tumors and if your lymph nodes are positive for cancer cells.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04329065' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.wingsofkaren.org/dr-king---dr-disis' target='_blank'>Wings of Karen: WOKVAC Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/neoadjuvant-therapy/' target='_blank'>Susan G. Komen: Neoadjuvant Therapies for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/perjeta-plus-herceptin-and-chemo-shows-benefits' target='_blank'>Breastcancer.org: Adding Perjeta to Herceptin and Chemotherapy After Surgery Shows Benefits in Early-Stage HER2-Positive Breast Cancer</a> </li></ul>
27
NEAREST SITE: 941 miles
University of Colorado Cancer Center
Aurora,CO
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05230810
Targeted Therapy for Metastatic HER2+ Breast Cancer with a PIK3CA Mutation
This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable or Metastatic Breast Cancer. Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of alpelisib (Piqray®) PI3K inhibitor and tucatinib (Tukysa) anti-HER2 targeted therapy with or without fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer with a PIK3CA mutation who have received 2+ anti-HER2 targeted therapies.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection (for people with HR positive breast cancer)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps HER2+ cancer cells grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors. You will only receive fulvestrant (Faslodex®) if you have HR+ (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women with HR+ breast cancer will also be given a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05230810' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
28
NEAREST SITE: 941 miles
University of Colorado - Anschutz Medical Campus - PPDS
Aurora,CO
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT05650879
ELVN-002 Targeted Therapy for Advanced HER2 Positive or HER2 Mutated Breast Cancer
A Phase 1a/1b Study of ELVN-002 for the Treatment of Patients With HER2 Mutant Non-Small Cell Lung Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ELVN-002, an experimental anti-HER2 targeted therapy, alone or with trastuzumab emtansine (Kadcyla®, T-DM1) antibody drug conjugate (ADC).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 mutated breast cancer who have received at least 1 line of therapy for advanced/metastatic disease.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ELVN-002, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ELVN-002, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (Kadcyla®, T-DM1), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ELVN-002 is an experimental anti-HER2 targeted therapy that targets the HER2 protein on breast cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (Kadcyla®, T-DM1) is an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (Kadcyla®, T-DM1)'s antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called emtansine.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05650879' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.enliventherapeutics.com/pipeline/' target='_blank'>Enliven Therapeutics: ELVN-002 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab Emtansine (Kadcyla®, T-DM1)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
29
NEAREST SITE: 1479 miles
Mary Crowley Cancer Research
Dallas,TX
VISITS: 1 visit every week for 1 year
PHASE: I
NCT ID: NCT05076591
IMM2902 Bispecific Antibody for Advanced HER2 Positive or HER2 Low Breast Cancer
A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients With HER2-Expressing Advanced Solid Tumors Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of IMM2902, an experimental targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who have received at least 2 lines of therapy. You must have at least 1 tumor that has not been treated with radiation.
Full eligibility criteria
Contact research site
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMM2902, by IV, weekly for 1 year</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMM2902 is an experimental targeted therapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">IMM2902 is a bispecific antibody that targets HER2 and CD47.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05076591' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.immuneonco.com/display.php?id=120' target='_blank'>ImmuneOnco Biopharmaceuticals Press Release: IMM2902</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/bispecific-antibodies-for-mbc/' target='_blank'>Metastatic Trial Talk: Bispecific Antibodies: An Emerging Class Of MBC Drugs</a> </li></ul>
30
NEAREST SITE: 1584 miles
University of Minnesota Masonic Cancer Center
Minneapolis,MN
VISITS: 1 visit every 3 weeks
PHASE: I
NCT ID: NCT05868226
PRE-I-SPY: Targeted Therapy and ADC for People with Advanced HER2+ or HER2 Low Breast Cancer
PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial (PRE-I-SPY-PI) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of evorpacept (ALX148) CD47 inhibitor with trastuzumab deruxtecan (T-DXd, Enhertu®) antibody drug conjugate (ADC).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who have received no more than 1 line of therapy for advanced disease.
Full eligibility criteria
Contact research site
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evorpacept (ALX148), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evorpacept (ALX148) is an experimental targeted therapy called a CD47 inhibitor. Blocking CD47 may help stimulate the immune system.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is a type of immunotherapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) uses the HER2-targeted antibody trastuzumab to deliver the chemotherapy DM1 directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH -.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05868226' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://alxoncology.com/science/' target='_blank'>ALX Oncology: Evorpacept (ALX148) Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (T-DXd, Enhertu®)</a> </li></ul>
31
NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05673928
Tucatinib and T-DM1 for HER2-Positive Breast Cancer with Brain Metastasis
A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB) Scientific Title
Purpose
To study the anti-cancer activity, safety and side effects of tucatinib and adotrastuzumab emtansine (T-DM1) for controlling brain metastases (breast cancer that has spread to the brain).
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 1 year</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1; Kadcyla®), by injection, every 3 weeks for 1 year</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps HER2+ cancer cells grow.</li> <li class="seamTextUnorderedListItem">T-DM1 is an antibody-drug conjugate (ADC). It uses the HER2-targeted therapy trastuzumab to deliver the chemotherapy DM1 directly to cancer cells.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05673928' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>breastcancer.org: Tucatinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: T-DM1</a> </li></ul>
32
NEAREST SITE: 1643 miles
The University of Texas MD Anderson Cancer Center
Houston,TX
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT05514717
XMT-2056 ADC for Advanced HER2+ or HER2 Mutated Breast Cancer
A Phase 1, First in Human, Dose Escalation and Expansion, Multicenter Study of XMT-2056 in Participants With Advanced/Recurrent Solid Tumors That Express HER2 Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of XMT-2056, an experimental antibody drug conjugate (ADC).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer or breast cancer with a HER2 mutation who have received standard treatment.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XMT-2056, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XMT-2056 is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">XMT-2056's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called Immunosynthen.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HER2</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05514717' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mersana.com/pipeline/overview/' target='_blank'>Mersana Therapeutics Drug Information Page: XMT-2056</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mersana.com/our-technology-platforms/about-adcs/' target='_blank'>Mersana Therapeutics: About ADCs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mersana.com/our-technology-platforms/immunosynthen/' target='_blank'>Mersana Therapeutics: Immunosynthen</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
33
NEAREST SITE: 1643 miles
MD Anderson Cancer Center
Houston,TX
VISITS: 1 visit every 3 weeks, over 1 year
PHASE: II
NCT ID: NCT04569747
Phesgo & Anti-Estrogen Therapy for Stage I HER2+, HR+ Breast Cancer
20-347 NCT Number Title A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer (ADEPT) Scientific Title
Purpose
To study the anti-cancer activity and side effects of giving a combination of anti-HER2 therapies by injection (instead of by IV) in combination with an anti-estrogen therapy.
Who is this for?
People with stage I node-negative, HER2 positive (HER2+), hormone positive (ER+ and/or PR+) breast cancer who have already had surgery.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) by injection, every 3 weeks, for one year</li> <li class="seamTextUnorderedListItem">Doctor's choice of anti-estrogen therapy, by mouth, daily, five years</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo is a combination of two anti-HER2 therapies-- Perjeta® (pertuzumab) and Herceptin® (trastuzumab). It also includes a protein called hyaluronidase which helps your body absorb the targeted therapies.</li> <li class="seamTextUnorderedListItem">Pertuzumab and trastuzumab are typically given by IV. With Phesgo, you can receive these therapies by injection, which shortens the length of time it takes to receive treatment. </li> <li class="seamTextUnorderedListItem">Phesgo is approved to treat early-stage and metastatic HER2+ breast cancer in combination with chemotherapy, but its use in this trial is considered experimental.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04569747' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/phesgo' target='_blank'>Breastcancer.org: Phesgo</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.phesgo.com/about-phesgo/what-is-phesgo.html?c=phe-172a973f1cf&gclid=Cj0KCQiAjKqABhDLARIsABbJrGnxbgo39_l5XXQbx8yILiLlmUh9lCEU_oytPfswusesUSR_aVudTBMaAknqEALw_wcB&gclsrc=aw.ds' target='_blank'>Genentech Drug Information Page: Phesgo</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/hormone-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: Hormone Therapy for Breast Cancer</a> </li></ul>
34
NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05243641
Targeted Therapy for Metastatic HER2- Breast Cancer with Abnormal HER-family and c-Met Signaling Activity
Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER2 and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of neratinib (Nerlynx®) anti-HER2 targeted therapy and capmatinib (Tabrecta®) MET/c-MET inhibitor.
Who is this for?
Phase Ib: People with metastatic (stage IV) breast cancer with any ER, PR, and HER2 status who have received 1-6 lines of therapy for metastatic disease.
Phase IIb: People with metastatic (stage IV) HER2 negative (HER2-) breast cancer with abnormal HER-family and c-Met signaling activity who have received 1-6 lines of therapy for metastatic disease.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth</li> <li class="seamTextUnorderedListItem">Capmatinib (Tabrecta®), by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is a type of anti-HER2 targeted therapy used to treat early-stage and metastatic HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Capmatinib (Tabrecta®) is a type of targeted therapy called a MET/c-Met inhibitor. Blocking MET/c-Met may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Your HER-family and c-Met signaling activity will be determined by CELsignia MP Test results.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with inflammatory breast cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HER-family, c-Met</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05243641' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/capmatinib-oral-route/side-effects/drg-20488162?p=1' target='_blank'>Mayo Clinic: Capmatinib (Tabrecta®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2020-0198.html' target='_blank'>MD Anderson Cancer Center Trial Information Page</a> </li></ul>
35
NEAREST SITE: 1643 miles
University of Texas MD Anderson Cancer Center
Houston,TX
VISITS: At least 8 visits within 6 months, then 1 visit every 6 months after surgery
PHASE: II
NCT ID: NCT05795101
TRUDI: Trastuzumab Deruxtecan ADC and Durvalumab Immunotherapy for Stage III HER2+ or HER2 Low Inflammatory Breast Cancer
TRUDI: A Phase II Study of Neoadjuvant Trastuzumab Deruxtecan and Durvalumab for Stage III, HER2-expressing Inflammatory Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) trastuzumab deruxtecan (Enhertu®) antibody drug conjugate (ADC) with durvalumab (Imfinzi®) PD-1 inhibitor.
Who is this for?
People with newly diagnosed stage III HER2 positive (HER2+) or HER2 low inflammatory breast cancer who have not yet received treatment.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks, 8 times</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks, 8 times</li> <li class="seamTextUnorderedListItem">Chest X-rays, every 1.5 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertru®) has been approved to treat HER2+ and HER2 low breast cancer. Its use in inflammatory breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) has been approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+ and ISH- or ISH untested.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05795101' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (Enhertu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/treatment/drugs/durvalumab' target='_blank'>Cancer Research UK: Durvalumab (Imfinzi®)</a> </li></ul>
36
NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT05633979
Valemetostat Targeted Therapy for Advanced HER2 Low, HER2 Ultra Low, or HER2 Null Breast Cancer
Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of valemetostat, an experimental EZH1/2 inhibitor, alone or with trastuzumab deruxtecan (Enhertu®) antibody drug conjugate (ADC).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 low, HER2 ultra low, or HER2 null breast cancer who have received at least 1 line of chemotherapy for advanced/metastatic disease. You must not have received treatment with any anti-HER2 targeted therapy.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Valemetostat, by mouth</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Valemetostat, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Valemetostat is an experimental targeted therapy called a EZH1/2 inhibitor. Blocking EZH1 and EZH2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) uses the HER2 targeted antibody trastuzumab to deliver the chemotherapy DM1/deruxtecan directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+/ISH- or IHC 1+/ISH- or undefined.</li> <li class="seamTextUnorderedListItem">HER2 ultra low is defined as IHC 0 with faint ISH staining.</li> <li class="seamTextUnorderedListItem">HER2 null is defined as IHC 0 with no ISH staining.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05633979' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2022-0315.html' target='_blank'>MD Anderson Cancer Center: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.daiichisankyo.com/rd/pipeline/' target='_blank'>Daiichi-Sankyo: Valemetostat Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (Enhertu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/her2-status/' target='_blank'>Metastatic Trial Talk: Why Knowing Your HER2 Status is Important</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/special-topics/enhertu-her2-low/' target='_blank'>Metastatic Trial Talk: FDA Approves Enhertu® for HER2-Low MBC</a> </li></ul>
37
NEAREST SITE: 1761 miles
University of Wisconsin
Madison,WI
VISITS: Every 3 weeks for 6 months
PHASE: II
NCT ID: NCT04886531
Targeted Therapy and Hormone Therapy Before Surgery for Stage I-III Triple Positive Breast Cancer
An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in Triple Positive Breast Cancers Hoosier Cancer Research Network BRE17-141 Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of neratinib (Nerlynx®) and trastuzumab (Herceptin®) anti-HER2 targeted therapies with letrozole (Femara®) or anastrozole (Arimidex®) hormone therapies before surgery (neoadjuvant).
Who is this for?
Postmenopausal women and men with stage I, stage II, or some stage III triple positive (ER+, PR+, HER2+) breast cancer who have not yet received surgery.
Full eligibility criteria
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- What's being studied?
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-
<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 3 weeks</li> </ul> <p class="seamTextPara"> followed 3 weeks later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> </ul> <p class="seamTextPara"> followed 3 weeks later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 3 weeks</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> </ul> <p class="seamTextPara"> followed 3 weeks later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 6 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) and trastuzumab (Herceptin®) are anti-HER2 targeted therapies used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) and anastrozole (Arimidex®) are a type of hormone therapy called aromatase inhibitors. They are commonly used to treat hormone receptor positive breast cancer.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04886531' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li></ul>
38
NEAREST SITE: 1851 miles
Northwestern University
Evanston,IL
VISITS: Approximately 22 visits over the first 2.5 months; then 1 visit every 2 weeks, ongoing
PHASE: I-II
NCT ID: NCT04588545
Radiation Therapy and HER2-Targeted Therapies Infused Directly into the Brain for HER2+ Breast Cancer with Leptomeningeal Metastases
Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease Scientific Title
Purpose
To study the anti-cancer activity and side effects of giving two anti-HER2 targeted therapies directly into the brain after giving radiation therapy to the brain or spine.
Who is this for?
People with metastatic (stage IV) HER2-positive (HER2+) breast cancer with leptomeningeal disease -- breast cancer that has spread to the leptomeninges (see below for the definition).
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy to the brain or spine, 5 to 10 times</li> <li class="seamTextUnorderedListItem">Surgery to place a device (Ommaya reservoir) similar to a chemotherapy port under your scalp</li> <li class="seamTextUnorderedListItem">followed by pertuzumab (Perjeta®) and trastuzumab (Herceptin®), by Ommaya reservoir, twice a week for one month, then once a week for one month, then every two weeks, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery or other times in the treatment process. </li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) is a HER2 targeted therapy commonly used to treat HER2-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer. </li> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">Ommaya reservoirs are very small plastic devices put under the scalp to give access to cerebrospinal fluid (CSF) -- the fluid or liquid surrounding your brain and spinal cord.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2+ cancer that have spread to the leptomeninges.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04588545' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: What are Leptomeningeal Metastases?</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/cancers/brain-tumor/leptomeningeal-disease/' target='_blank'>Moffitt Cancer Center: Leptomeningeal Disease</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/faq-about-ommaya-reservoirs-and-ommaya-taps' target='_blank'>Memorial Sloan Kettering Cancer Center: Frequently Asked Questions About Ommaya Reservoirs and Ommaya Taps</a> </li></ul>
39
NEAREST SITE: 1959 miles
SCRI Oncology Partners
Nashville,TN
VISITS: 1 visit every month
PHASE: II
NCT ID: NCT05748834
Tucatinib Targeted Therapy and Doxil Chemotherapy for Advanced HER2+ Breast Cancer
Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for the Treatment of HER2+ Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of tucatinib (Tukysa®) tyrosine kinase inhibitor with doxorubicin (Doxil®) chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received anti-HER2 targeted therapy.
Full eligibility criteria
Contact research site
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, monthly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps HER2+ cancer cells grow.</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) is a chemotherapy drug commonly used to treat breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05748834' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/doxil' target='_blank'>Breastcancer.org: Doxorubicin (Doxil®)</a> </li></ul>
40
NEAREST SITE: 2352 miles
University of Rochester
Rochester,NY
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT04965064
Neratinib Targeted Therapy with Capecitabine Chemotherapy for Metastatic HER2 Negative Breast Cancer with Abnormally Active HER2 Signaling and Brain Metastases
An Open-Label Phase II Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of neratinib (Nerlynx®) anti-HER2 targeted therapy with capecitabine (Xeloda®) chemotherapy.
Who is this for?
People with metastatic (stage IV) HER2 negative (HER2-) breast cancer with abnormally active HER2 signaling that has spread to the brain (brain metastasis).
Full eligibility criteria
Contact research site
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 day off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells from growing by targeting and blocking the HER2 proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an oral drug approved by the U.S. Food and Drug Administration (FDA) to treat HER2 positive breast cancer. It is considered investigational in this study because your breast cancer was determined to be HER2 negative by the standard method of testing. However, the CELsignia test showed that your breast cancer cells have HER2 pathway activity that might respond to HER2-targeted treatment.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug that may slow or stop breast cancer cells from growing.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04965064' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li></ul>
41
NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL
VISITS: 1 visit every week
PHASE: II
NCT ID: NCT05325632
Dendritic Cell Vaccine With Neoadjuvant Therapy for HER2 Positive Breast Cancer
A Phase II Study of Human Epidermal Growth Factor Receptor 2 (HER-2) Directed Dendritic Cell (DC1) Vaccine Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of a dendritic cell vaccine, an experimental immunotherapy, with targeted therapy and chemotherapy before surgery (neoadjuvant).
Who is this for?
People with stage I, stage II, or some stage III HER2 positive (HER2+) breast cancer who have not received surgery.
Full eligibility criteria
Contact research site
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to remove white blood cells</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, weekly for 6 weeks, then 3 times within 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 5 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks for 5 months</li> </ul> <p class="seamTextPara"> followed 2 months later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Abraxane®), by IV, weekly for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove tumor</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is an experimental immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">You will receive a dendritic cell vaccine made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The white blood cells, called dendritic cells, are removed from your body during a procedure called apheresis. These cells are processed in a lab so that they will see and go after HER2+ cancer cells, and then they will be injected as a vaccine.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are types of anti-HER2 targeted therapy used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Abraxane®) is a chemotherapy drug commonly used for breast cancer.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like hormone therapy or targeted therapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05325632' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/vaccines-to-treat-cancer' target='_blank'>Cancer Research UK: Dendritic Cell Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cancer-vaccines' target='_blank'>Breastcancerorg: Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancerorg: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/perjeta' target='_blank'>Breastcancerorg: Pertuzumab (Perjeta®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancerorg: Paclitaxel (Abraxane®)</a> </li></ul>
42
NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL
VISITS: May require hospital stay
PHASE: I
NCT ID: NCT05378464
T-Cell Therapy, Dendritic Cell Vaccine & Targeted Therapy for HER2+ Metastatic Breast Cancer
Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of T-cell therapy after dendritic cell vaccines with pepinemab, an experimental targeted therapy, and trastuzumab (Herceptin®), a HER2-targeted therapy.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that progressed on trastuzumab (Herceptin®). You must not have received more than 3 lines of therapy for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, weekly for 6 weeks</li> <li class="seamTextUnorderedListItem">Pepinemab, by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> followed by (2 weeks after last vaccine): </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">T-cell therapy, by IV, 2 sessions over 2 weeks</li> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, every 3 weeks for at least 2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis to collect your T cells</li> <li class="seamTextUnorderedListItem">May require hospital stay</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-cell therapy is a type of immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your T-cells are removed from your body during a process called leukapheresis, modified with CD4+ that allows them to attack HER2 positive cancer cells, and then infused back into your body.</li> <li class="seamTextUnorderedListItem">Before you receive the T-cells, you will be treated with the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your body to receive the T-cells.</li> <li class="seamTextUnorderedListItem">Dendritic cell vaccines are a type of immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Pepinemab is an experimental targeted therapy called a SEMA4D inhibitor. Blocking SEMA4D may stop or slow cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a HER2-targeted therapy commonly used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">After receiving the modified T-cells, you will continue to receive pepinemab, trastuzumab (Herceptin®), and booster doses of the dendritic cell vaccine every 3 weeks.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05378464' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adoptive-cell-therapy' target='_blank'>National Cancer Institute: Adoptive T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/vaccines-to-treat-cancer' target='_blank'>Cancer Research UK: Dendritic Cell Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.vaccinex.com/pipeline/pepinemab-immuno-oncology/' target='_blank'>Vaccinex Drug Information Page: Pepinemab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>
43
NEAREST SITE: 2425 miles
NEXT Oncology Virginia
Fairfax,VA
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT06239467
OKI-219 Targeted Therapy for Advanced HR+ Breast Cancer with PI3K Mutations
PIKture-01: First-in-Human Study of the PI3KÃŽ±H1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and in Combination With Endocrine Therapy or HER2-Targeted Therapy in Participants With Advanced Breast Cancer (PIKture-01) Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of OKI-219, an experimental PI3Kα inhibitor, with fulvestrant (Faslodex®) hormone therapy or trastuzumab (Herceptin®) anti-HER2 targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 positive (HER2+) breast cancer with a PI3KαH1047R mutation.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: HR positive, HER2 negative</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OKI-219, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: HER2 positive</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OKI-219, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PI3KαH1047R is a common type of PI3KCA mutation.</li> <li class="seamTextUnorderedListItem">OKI-219 is an experimental targeted therapy called a PI3Kα inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated which allows cancer cells to grow. OKI-219 may block the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy called a selective estrogen receptor degraders (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06239467' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://onkuretherapeutics.com/pipeline/' target='_blank'>OnKure: OKI-219 Drug Information Page</a> </li></ul>
44
NEAREST SITE: 2425 miles
NEXT Virginia
Fairfax,VA
VISITS: 1 visit every 3 weeks
PHASE: I
NCT ID: NCT06328738
ELVN-002 Targeted Therapy for Advanced HER2+ Breast Cancer
A Phase 1a/1b Study of ELVN-002 Combined With Trastuzumab in Advanced Stage HER2+ Solid Tumors, and ELVN-002 Combined With Trastuzumab and Chemotherapy in Advanced Stage HER2+ Colorectal Cancer and Breast Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ELVN-002, an experimental anti-HER2 targeted therapy, with trastuzumab (Herceptin®) anti-HER2 targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who have received paclitaxel (Abraxane®) or docetaxel (Taxotere®) chemotherapy, pertuzumab (Perjeta®), trastuzumab (Herceptin®), and trastuzumab deruxtecan (Enhertu®).
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ELVN-002, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ELVN-002 is an experimental anti-HER2 targeted therapy.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+ / ISH+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06328738' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.enliventherapeutics.com/pipeline/' target='_blank'>Enliven Therapeutics: ELVN-002 Drug Information Page</a> </li></ul>
45
NEAREST SITE: 2434 miles
Georgetown Lombardi Comprehensive Cancer Center
Washington,DC
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05256745
Azeliragon to Decrease Cardiotoxicity and Cognitive Decline During Chemotherapy in Women with Stage I-III Breast Cancer
RAGE Inhibition to Decrease Cancer Therapy Related Cardio Toxicity in Women With Early Breast Cancer Scientific Title
Purpose
To study the ability of azeliragon to decrease cardiotoxicity (heart damage caused by cancer treatment) and cognitive decline side effects of chemotherapy.
Who is this for?
Women with stage I, stage II, or stage III breast cancer who have not yet received treatment and are planning to receive chemotherapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Azeliragon with AC/T Chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), 5.5 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 5.5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), 5.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Azeliragon with CT Chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), 3-4 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 3-4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Azeliragon with TCHP Chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), 4 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), 4 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), 4 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), 4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4: Azeliragon with Combination of Chemotherapy and Targeted Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), 4 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 3-4 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), 5.5 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), depending on type of cancer</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), 4 months, depending on type of cancer</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon is an experimental drug that may reduce cardiotoxicity and cognitive decline side effects of chemotherapy. It is also being studied for treating Alzheimer's and glioblastoma, a type of brain cancer.</li> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity. </li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), cyclophosphamide (Cytoxan®), paclitaxel (Taxol®), docetaxel (Taxotere®), and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and Pertuzumab (Perjeta®) are anti-HER2 targeted therapies routinely used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05256745' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/16858-chemotherapy--the-heart-cardiotoxicity#:~:text=Cardiotoxicity%20refers%20to%20any%20heart,radiation%20therapy%20to%20the%20chest.' target='_blank'>Cleveland Clinic: Cardiotoxicity Cancer Treatment and the Heart</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/fda-grants-orphan-drug-designation-to-azeliragon-for-gbm' target='_blank'>OncLive: Azeliragon for Brain Cancer and Cancer Treatment-Related Complications</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-anti-her2-therapies' target='_blank'>Breastcancer.org: Anti-HER2 Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
46
NEAREST SITE: 2539 miles
Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)
Basking Ridge,NJ
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05892068
Tucatinib Before Surgery for Metastatic HER2+ Breast Cancer That Has Spread to the Brain
Window of Opportunity Analysis of Pre-Operative Tucatinib for Surgically Resected HER2+ Brain Metastases: Understanding Mechanisms of Resistance Scientific Title
Purpose
To study how the brain absorbs, distributes, and gets rid of tucatinib (Tukysa®) in people who have HER2+ breast cancer that has spread to the brain, and to learn more about how cancer cells develop resistance to treatment.
Who is this for?
Women with metastatic (stage IV) HER2+ breast cancer that has spread to the brain (brain metastases) and who are planning to receive surgery to remove the cancer.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 5 days</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa) is a type of HER2 targeting therapy called a kinase inhibitor. It is able to cross the blood-brain barrier. This means it works against cancer cells that have spread to the brain. Tucatinib is approved for use in people with metastatic, HER2+ breast cancer when it is taken with trastuzumab and capecitabine. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05892068' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib</a> </li></ul>
47
NEAREST SITE: 2567 miles
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York,NY
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT06058988
Trastuzumab Deruxtecan Antibody Drug Conjugate for Metastatic HER2 Positive, Low, or Mutated Breast Cancer with Brain Metastases
Window of Opportunity Assessment of [Fam-]Trastuzumab DERuxtecan-nxki (T-DXd) Brain Tumor Penetration and Efficacy (WOnDER-BT) Scientific Title
Purpose
To study the safety, effects, and anti-cancer activity of trastuzumab deruxtecan (T-DXd, Enhertu®) antibody-drug conjugate (ADC) for people with brain metastases.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+), HER2 low, or HER2 mutated breast cancer that has spread to the brain (brain metastasis) and are planning to receive brain surgery.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC1+ or 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06058988' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (T-DXd, Enhertu®)</a> </li></ul>
48
NEAREST SITE: 2587 miles
Miami Cancer Institute at Baptist Health, Inc.
Miami,FL
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT05553522
Targeted Therapy, Chemotherapy, and Stereotactic Radiosurgery for Metastatic HER2+ Breast Cancer with Brain Metastases
Phase 1 Trial of Tucatinib, Trastuzumab, and Capecitabine With Stereotactic Radiosurgery (SRS) in Patients With Brain Metastases From HER-2 Positive Breast Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of stereotactic radiosurgery (SRS) with tucatinib (Tukysa®) tyrosine kinase inhibitor, capecitabine (Xeloda®) chemotherapy, and trastuzumab (Herceptin®) anti-HER2 targeted therapy.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain (brain metastasis). Your brain metastases must be newly diagnosed.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS)</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 2 weeks</li> </ul> <p class="seamTextPara"> followed 2 weeks later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps HER2+ cancer cells grow.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS, stereotactic radiation) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">The combined use of SRS with the three drugs is considered investigational.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05553522' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</a> </li></ul>
49
NEAREST SITE: 2591 miles
University of Miami
Miami,FL
VISITS: Number of visits unavailable
PHASE: NA
NCT ID: NCT05959291
Free-HER: Stopping Maintenance Anti-HER2 Targeted Therapy for People with Metastatic HER2+ Breast Cancer and No Evidence of Disease
Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer Scientific Title
Purpose
To study if people who stop taking anti-HER2 targeted therapy for maintenance will stay in complete remission.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who have been in complete remission, also called no evidence of disease (NED), for at least 3 years and have been receiving anti-HER2 targeted therapy for at least 3 years.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stop taking anti-HER2 targeted therapy</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Imaging scans</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a type of anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Complete remission is also known as no evidence of disease (NED).</li> <li class="seamTextUnorderedListItem">Blood tests will measure circulating tumor DNA (ctDNA), which are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">You will continue to receive routine monitoring, blood tests, and imaging scans.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05959291' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: What is Anti-HER2 Targeted Therapy?</a> </li></ul>
50
NEAREST SITE: 2594 miles
Mount Sinai Medical Center
Miami Beach,FL
VISITS: 1 visit every 3 weeks
PHASE: III
NCT ID: NCT05950945
Trastuzumab Deruxtecan ADC for People with Advanced HER2 Negative or HER2 Low Breast Cancer
A Phase 3b, Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of trastuzumab deruxtecan (T-DXd, Enhertu®) antibody drug conjugate (ADC) for advanced HER2 negative or HER2 low breast cancer.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer with HER2 negative (IHC 0) or HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received 1-2 lines of therapy for advanced disease. You must not have received anti-HER2 targeted therapy for advanced disease or any antibody drug conjugate (ADC).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®) is a type of immunotherapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) uses the HER2-targeted antibody trastuzumab to deliver the chemotherapy DM1 directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05950945' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.destinyclinicaltrials.com/en#DESTINY-breast' target='_blank'>AstraZeneca: DESTINY Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (Enhertu®)</a> </li></ul>
51
NEAREST SITE: 2619 miles
Dartmouth Hitchcock Medical Center
Lebanon,NH
VISITS: 1 visit every month
PHASE: II
NCT ID: NCT05933395
Hormone Therapy and Targeted Therapy Based on Biomarker Testing for Advanced ER+, HER2- Breast Cancer
Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of hormone therapy and targeted therapy based on biomarker testing.
Who is this for?
Post-menopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) or HER2 low breast cancer. You must have received treatment with palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®) for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 4 groups based on biomarker testing results: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive treatment based on ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1 biomarker testing results.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells from growing by targeting and blocking the HER2 proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH -.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05933395' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>
52
NEAREST SITE: 2693 miles
Dana Farber Cancer Institite
Boston,MA
VISITS: 1 visit every 1-2 weeks
PHASE: II
NCT ID: NCT06100874
Sacituzumab Govitecan ADC and Trastuzumab Targeted Therapy for Advanced HER2+ Breast Cancer
A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After progrEssion on ENhertu (SATEEN) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of trastuzumab deruxtecan (Enhertu®, T-DXd) antibody drug conjugate (ADC) with trastuzumab (Herceptin®) anti-HER2 targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received treatment with trastuzumab (Herceptin®), trastuzumab deruxtecan (Enhertu®), and paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), or docetaxel (Taxotere®).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd), weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV or injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">CT or MRI scans, every 2-3 months</li> <li class="seamTextUnorderedListItem">Heart scan, every 3-4 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Herceptin® Hylecta is a form of trastuzumab that is given by injection instead of by IV.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06100874' target='_blank'>ClinicalTrials.gov</a> </li></ul>
