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(Last updated: October 14, 2021)

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NEAREST SITE: 2 miles
San Francisco General Hospital
San Francisco,CA

VISITS: 1 visit every 3 weeks

PHASE: III

NCT ID: NCT03975647

Trastuzumab Emtansine/T-DM1 Alone or with Tucatinib for Advanced, HER2+ Breast Cancer

Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer Scientific Title

Purpose

To compare the anti-cancer activity and side effects of giving of the anti-HER2 targeted therapy tucatinib (Tukysa®) and trastuzumab emtansine/T-DM1 (Kadcyla®) together to just giving trastuzumab emtansine/T-DM1 (Kadcyla®).

Who is this for?

People with locally advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have previously been treated with a taxane and trastuzumab (Herceptin®). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is an anti-HER2-targeted therapy approved for use with certain 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 deliver the chemotherapy DM1 directly to the cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03975647' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tukysahcp.com' target='_blank'>Seagen Information Page: Tukysa (Tucatinib)</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.onclive.com/publications/oncology-live/2018/vol-19-no-24/tucatinib-shows-promise-in-patients-with-breast-cancer-and-brain-metastases' target='_blank'>OncLive: Tucatinib Shows Promise in Patients With Breast Cancer and Brain Metastases</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/news/tucatinib-shows-promise-phase-i-study-her2-positive-breast-cancer' target='_blank'>CancerNetwork:Tucatinib Shows Promise in Phase I Study of HER2-Positive Breast Cancer</a> </li></ul>

NEAREST SITE: 3 miles
University of California at San Francisco
San Francisco,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT01969643

SGN-LIV1A for Women With Advanced HER2 Negative Breast Cancer

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With LIV-1-Positive Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, best dose and anti-tumor activity of SGN-LIV1A--an experimental antibody-drug conjuate (ADC).

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-LIV1A, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <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">SGN-LIV1A is an antibody-drug conjugate.</li> <li class="seamTextUnorderedListItem">Its antibody targets LIV-1 (SLC39A6), a protein that is expressed by most breast cancer cells, and it delivers an anti-cancer drug called monomethyl auristatin E.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01969643' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.seagen.com/science/pipeline/ladiratuzumab-vedotin' target='_blank'>Seagen Drug Information Page: Ladiratuzumab Vedotin (SGN-LIV1A)</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></ul>

NEAREST SITE: 3 miles
University of California San Francisco Medical Center
San Francisco,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT04042701

Trastuzumab Deruxtecan and Pembrolizumab for Advanced HER2 Positive and HER2 Low Expression 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 find the best dose and to study the safety, effects (good and bad), and anti-tumor activity of the targeted therapy fam-trastuzumab deruxtecan-nxki (Enhertu®) when it is given in combination with the immunotherapy pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low expression breast cancer whose cancer progressed after receiving trastuzumab emtansine/T-DM1 (Kadcyla®) or standard of care therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtecan-nxki (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>
<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://en.wikipedia.org/wiki/Pembrolizumab' target='_blank'>Wikipedia: Pembrolizumab</a> </li></ul>

NEAREST SITE: 3 miles
Kaiser Permanente-San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02465060

NCI-MATCH: Using Genomic Test Results To Choose A Targeted Therapy For Metastatic Breast Cancer

A Basket study: Molecular Analysis for Therapy Choice (MATCH) Scientific Title

Purpose

To study the anti-cancer activity of receiving a targeting therapy that was chosen based on the results of your tumor's genomic testing.

Who is this for?

People with metastatic (stage IV) breast cancer whose cancer progressed during or after standard of care treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</li> <li class="seamTextUnorderedListItem">Your tumor sample will be tested for genetic mutations (genomic testing)</li> <li class="seamTextUnorderedListItem">You will be assigned to 1 of 24 treatment groups based on the results of your tumor's genomic test</li> <li class="seamTextUnorderedListItem">End-of-treatment biopsy and collection of blood samples for research purposes (optional)</li> <li class="seamTextUnorderedListItem">This process may be repeated if your disease progresses</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genomic testing looks at genetic mutations within your tumor.</li> <li class="seamTextUnorderedListItem">The drug you receive will be determined by the results of your tumor's genomic test. </li> <li class="seamTextUnorderedListItem">Your may receive one or more of the following drugs: Adavosertib, Afatinib, Binimetinib, Capivasertib, Copanlisib, Crizotinib, Dabrafenib, Dasatinib, Defactinib, Erdafitinib, FGFR Inhibitor AZD4547, Larotrectinib, Nivolumab, Osimertinib, Palbociclib (CDK inhibitor), Pertuzumab (anti-HER2), PI3K-beta Inhibitor GSK2636771, Sapanisertib, Sunitinib Malate, Taselisib, Trametinib, Trastuzumab emtansine/T-DM1 (Kadcyla®) (antibody-drug conjugate (ADC)), Vismodegib</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer. </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">Targets or mutations: ABL, ALK, BRAF, CDK4, CDK6, CSF-1R, EGFR, EGFR T790M, FGFR, FLT3, HER2 (ERBB2), KIT, MET, MEK, mTOR, NTRK fusions, PD-1, PDGFR, PI3K, PTCH1, PTEN loss, RET, ROS1, SMO, TRK, VEGFR, WEE1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02465060' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match' target='_blank'>National Cancer Institute Study Website: NCI-Match</a> </li><li class='seamTextUnorderedListItem'><a href='https://ecog-acrin.org/nci-match-eay131' target='_blank'>ECOG-ACRIN Cancer Research Group: NCI-Match</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/diagnosis/genomic_assays' target='_blank'>Breastcancer.org: Tumor Genomic Assay Testing</a> </li></ul>

NEAREST SITE: 8 miles
Epic Care Partners in Cancer Care
Emeryville,CA

VISITS: 1 visit every week (2 weeks on, 1 week off), ongoing

PHASE: II

NCT ID: NCT04647916

Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases

A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases Scientific Title

Purpose

To study the anti-cancer activity, safety and side effects of giving the antibody-drug conjugate sacituzumab govitecan (Trodelvy®) to treat brain metastases (breast cancer that has spread to the brain).

Who is this for?

People with metastatic (stage IV) HER2 negative (HER2-) breast cancer that has spread to the brain. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells.</li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan is approved for use in people with metastatic triple negative breast cancer who have already received at least two other therapies for metastatic disease, but its use in this trial is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04647916' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-sacituzumab-govitecan-triple-negative-breast-cancer' target='_blank'>NCI Cancer Currents Blog: Sacituzumab Govitecan Approved for Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/sacituzumab-govitecan-shows-pfs-benefit-for-patients-with-mtnbc-and-brain-metastases' target='_blank'>Targeted Oncology: Sacituzumab Govitecan Shows PFS Benefit for Patients With mTNBC and Brain Metastases</a> </li></ul>

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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This is a 2-part study. Depending upon which part of the trial is open when you enroll, you will receive the following: Part 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001</li> </ul> Part 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule.
<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>
<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>

NEAREST SITE: 53 miles
Research Site
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04494425

Trastuzumab Deruxtecan or Chemotherapy for Metastatic HR+, HER2-Low Breast Cancer

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06) Scientific Title

Purpose

To compare the anti-cancer activity, safety, and side effects of giving trastuzumab deruxtecan (Enhertu®) to giving chemotherapy.

Who is this for?

People with metastatic (stage IV) hormone-positive (ER+ and/or PR+), HER2-Low breast cancer who have already received at least one anti-hormone therapy for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your doctor's choice of chemotherapy: capecitabine (Xeloda®), paclitaxel (Taxol®), or nab-paclitaxel (Abraxane®) ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtican (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy drug directly to the cancer cells. It is approved 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">The chemotherapies capecitabine (Xeloda®), paclitaxel (Taxol®), and nab-paclitaxel (Abraxane®) are all commonly used to treat metastatic breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04494425' target='_blank'>ClinicalTrials.gov</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> </li><li class='seamTextUnorderedListItem'><a href='https://www.enhertu.com/en/gastric/?utm_source=google&utm_medium=cpc&utm_campaign=branded+general_2020&utm_content=branded+general_exact&utm_term=trastuzumab+deruxtecan&gclid=cj0kcqias5ecbhcbarisaehk4r7igokn76-yzybu0ziqrknxg5sw-w0t3uyeq-25nhutdetkzoiiwuua' target='_blank'>Daiichi Sankyo Company Drug Information Page: Enhertu® (Fam-Trastuzumab Deruxtican-nxki)</a> </li></ul>

NEAREST SITE: 273 miles
Samsun Clinic
Santa Barbara,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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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARX788, by IV, once a month, ongoing</li></ul>
<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>
<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>

NEAREST SITE: 326 miles
Kaiser Permanente
Woodland Hills,CA

VISITS: 1 visit every 3 weeks

PHASE: III

NCT ID: NCT04622319

Antibody-Drug Conjugate before Surgery for Stage I-III, HER2+ Breast Cancer Already Treated with Chemo & an Anti-HER2 Therapy

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05) Scientific Title

Purpose

To compare the anti-cancer activity of two antibody-drug conjugates -- trastuzumab deruxtecan-nxki (Enhertu®) and trastuzumab emtansine/T-DM1 (Kadcyla®).

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. Remaining cancer cells must have been found in your breast or lymph nodes during surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant chemotherapy and anti-HER2 targeted therapy (treatment given before surgery) are used to shrink tumors and to see how cancer responds to certain treatments. </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">This trial is for people who still had some tumor remaining at the time of surgery. </li> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtecan-nxki (Enhertu®) is an antibody-drug conjugate (ADC). It targets the HER2 protein on cancer cells 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, but 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 deliver the chemotherapy DM1 directly to the cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04622319' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/fda-approves-enhertu-for-her2-pos-mbc' target='_blank'>Breastcancer.org: FDA Approves Enhertu for Unresectable or Pretreated Metastatic HER2-Positive Breast Cancer</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></ul>

NEAREST SITE: 336 miles
University of California, Los Angeles
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03401385

DS-1062a in Advanced Triple Negative Breast Cancer

Phase 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of DS-1062a.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-1062a</li> <li class="seamTextUnorderedListItem">2 biopsies</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-1062a is an investigational antibody-drug conjugate (ADC). This type of drug uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells.</li> <li class="seamTextUnorderedListItem">The antibody in this drug targets Trop-2 proteins. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03401385' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793720' target='_blank'>NCI Drug Dictionary: DS-1062a</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>Metastatic Trial Talk: Getting to the Target, Antibody Drug Conjugates in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 336 miles
UCLA Hematology-Oncology
Santa Monica,CA

VISITS: 1 visit every 3 or 4 weeks, ongoing

PHASE: I

NCT ID: NCT03255070

ARX788 for HER2 Positive Advanced Breast Cancer

A Phase 1, Multicenter, Open-label, Multiple Dose-escalation Study of ARX788, Intravenously Administered as a Single Agent in Subjects With Advanced Cancers With HER2 Expression Scientific Title

Purpose

To evaluate the safety, effects (good and bad) and best dose of ARX788.

Who is this for?

People with HER2 positive advanced (some stage III) or metastatic (stage IV) breast cancer that has not responded to standard therapies and has already been treated with trastuzumab (Herceptin®). Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARX788, by IV, every 3 or 4 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARX788 is an antibody-drug conjugate (ADC). </li> <li class="seamTextUnorderedListItem">It uses an antibody that targets HER2 positive cancer cells to deliver a chemotherapy called amberstatin269 directly to these cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03255070' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://ambrx.com/pipeline/arx788-aher2-adc-oncology/' target='_blank'>Drug Company Information Page: ARX788 HER2 ADC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-her2-antibody-drug-conjugate-arx788' target='_blank'>NCI Drug Dictionary: ARX788</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.hematologyandoncology.net/archives/april-2017/antibody-drug-conjugates-in-breast-cancer/' target='_blank'>Clinical Advances in Hematology & Oncology: ADC in Breast Cancer</a> </li></ul>

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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You will be randomly assigned to 1 of 2 groups and recieve the following before surgery: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, over 4.5 months</li> </ul> Group 2 <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>
<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>
<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>

NEAREST SITE: 336 miles
UCLA Department of Medicine - Hematology & Oncology
Los Angeles,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT04539938

Tucatinib and Trastuzumab Deruxtecan for Advanced HER2 Positive Breast Cancer

A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination With Trastuzumab Deruxtecan in Subjects With Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer Scientific Title

Purpose

To study the anti-cancer activity and side-effects of giving tucatinib (Tukysa) in combination with fam-trastuzumab deruxtecan-nxki (Enhertu®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer. You must have already received at least two anti-HER2 targeted therapies for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa), by mouth, twice daily, ongoing</li> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa) is a type of HER2 targeting therapy called a kinase inhibitor. </li> <li class="seamTextUnorderedListItem">It is able to cross the blood-brain barrier. This means it works against cancer cells that have spread to the brain. </li> <li class="seamTextUnorderedListItem">Tucatinib is approved for use in people with metastatic, HER2+ breast cancer when it is taken with for use trastuzumab and capecitabine. Its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Fam-trastuzumab deruxtecan-nxki (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">It is approved for use to treat people with metastatic HER2+ breast cancer who have already received two anti-HER2 therapies but its use in this trial is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04539938' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/tukysa' target='_blank'>Breastcancer.org: Tukysa</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/view/what-you-need-to-know-about-the-fdas-approval-of-tukysa-for-her2positive-breast-cancer' target='_blank'>Cure Today: What You Need to Know About the FDA's Approval of Tukysa for HER2 Positive Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.enhertuhcp.com/en/?utm_source=google&utm_medium=cpc&utm_campaign=branded+general_2020&utm_content=branded+general_2020_exact&utm_term=enhertu&gclid=cj0kcqjw8fr7brdsarisak0qqr5x8-k8j8h3d3_wahp-jhjvjjtjaqr3dnefidhs2onmte7b9gbmcfmaaoteealw_wcb&gc' target='_blank'>Daiichi-Sankyo AstraZeneca Drug Information Page: Enhertu®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/brufsky-spotlights-data-with-trastuzumab-deruxtecan-in-her2-metastatic-breast-cancer' target='_blank'>OncLive: Trastuzumab Deruxtecan in HER2+ Metastatic Breast Cancer</a> </li></ul>

NEAREST SITE: 339 miles
UCLA Department of Medicine - Hematology/Oncology
Santa Monica,CA

VISITS: Number of visits unavailable, ongoing

PHASE: I-II

NCT ID: NCT03729596

Targeted Therapy MGC018 Alone or with Immunotherapy MGA012 in Advanced Triple Negative Breast Cancer

A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad) and anti-cancer activity of the experimental antibody-drug conjugate MC108 given alone or given with the experimental PD-1 inhibitor MGA012.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV), triple negative (ER-, PR-, HER2-) breast cancer who have already received at least one therapy. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGC018, by IV, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGC018, by IV, ongoing</li> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab), by IV, ongoing</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MC108 is an experimental antibody-drug conjugate (ADC)--it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells.</li> <li class="seamTextUnorderedListItem">In MC108, the antibody targets B7-H3 proteins and delivers the chemotherapy duocarmycin.</li> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab) is a type of immunotherapy called a checkpoint inhibitor or 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 trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03729596' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.macrogenics.com/mgc018-b7-h3/' target='_blank'>MacroGenics Drug Information Page: MGC018</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.3071' target='_blank'>ASCO Abstract: MGC018 (anti-B7-H3 antibody-drug conjugate) in Patients with Advanced Solid Tumors.</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Duocarmycin' target='_blank'>Wikipedia: Duocarmycin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pd-1-monoclonal-antibody-mga012' target='_blank'>NCI Drug Dictionary: MGA012</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.macrogenics.com/mga012-pd-1/' target='_blank'>MacroGenics Drug Information Page: MGA012 (Retifanlimab)</a> </li></ul>

NEAREST SITE: 339 miles
Angeles Clinic and Research Institute, The
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04042480

SGN-CD228A For Advanced HER2 Negative Breast Cancer

A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors Scientific Title

Purpose

To study the safety and effects (good and bad) of an antibody-drug conjugate called SGN-CD228A.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative breast cancer who have already been treated with a taxane. If your tumor is ER+, you must already have been treated with a CDK4/6 inhibitor and an anti-estrogen therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-CD228A, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of cancer therapy that combines an antibody that targets cancer cells with a drug that can kill cancer cells. </li> <li class="seamTextUnorderedListItem">SGN-CD228A targets CD228, a protein found on several types of cancer cells. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04042480' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.marketwatch.com/press-release/seattle-genetics-highlights-antibody-drug-conjugate-innovation-and-immuno-oncology-program-at-the-american-association-for-cancer-research-aacr-annual-meeting-2019-03-27' target='_blank'>Press Release: SGN-CD228A</a> </li></ul>

NEAREST SITE: 339 miles
UCLA
Santa Monica,CA

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT04064359

OBT076 in Advanced HER2 Negative Breast Cancer That Tests Positive for CD205

A Phase I, Open-label, Dose Finding Study to Assess the Safety, Tolerability, PK, and Preliminary Efficacy of OBT076, a CD205-directed ADC, in Recurrent and/or Metastatic CD205+ Solid Tumors and CD205+ HER2-negative Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, best dose, and side effects (good and bad) of the investigational targeted therapy OBT076.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer whose tumor tests positive for the CD205 protein and who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OBT076, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OBT076 is a type of therapy called an antibody-drug conjugate (ADC). These therapies combine an antibody that can find the cancer cells with a drug that can kill them. </li> <li class="seamTextUnorderedListItem">The antibody in OBT076 targets the CD205 protein and delivers a drug to make the immune system see cancer cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CD205</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04064359' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Antibody-drug_conjugate' target='_blank'>Wikipedia: Antibody-drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/ChemotherapyandTargetedTherapy.html' target='_blank'>Susan G. Komen: Emerging Areas</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/antibody-drug-conjugate' target='_blank'>NCI Dictionary of Cancer Terms: Antibody-drug Conjugate</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.aacr.org/from-the-journals-editors-picks-for-september/' target='_blank'>AACR Blog: Editors’ Picks for September</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.menarini.com/Home/Innovation-Research/MEN1309' target='_blank'>Drug Company Information Page: MEN1309 (OBT076)</a> </li></ul>

NEAREST SITE: 341 miles
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
Los Angeles,CA

VISITS: Visits every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03310957

SGN-LIV1A and Immunotherapy for Advanced Triple Negative Breast Cancer

Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of using SGN-LIV1A--an experimental antibody-drug conjugate--in combination with the immunotherapy pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received chemotherapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-LIV1A, by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <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">SGN-LIV1A is an antibody-drug conjugate. Its antibody targets LIV-1 (SLC39A6), a protein that is expressed by most breast cancer cells, and it delivers an anti-cancer drug called monomethyl auristatin E.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy drug called a PD-1 inhibitor. It blocks the PD-1 (programmed cell death-1) protein, making it possible for the body's immune system to go after cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03310957' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.seagen.com/science/pipeline/ladiratuzumab-vedotin' target='_blank'>Seagen Drug Information Page: Ladiratuzumab Vedotin (SGN-LIV1A)</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.keytruda.com' target='_blank'>Merck Drug Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 341 miles
Cedar-Sinai
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03504488

AB-ROR2-ADC for Advanced Breast Cancer

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety and effects (good and bad) of an experimental drug called CAB-ROR2-ADC (BA3021).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has not responded to standard therapies. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAB-ROR2-ADC (BA3021) </li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAB-ROR2-ADC is a type of drug called an antibody-drug conjugate (ADC). </li> <li class="seamTextUnorderedListItem">This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells. </li> <li class="seamTextUnorderedListItem">The antibody in this drug targets ROR2 proteins. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03504488' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/794991' target='_blank'>NCI Drug Dictionary: CAB-ROR2-ADC</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/78/13_Supplement/833' target='_blank'>Cancer Research: Anti-tumor efficacy of BA3021</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.hematologyandoncology.net/archives/april-2017/antibody-drug-conjugates-in-breast-cancer/' target='_blank'>Clinical Advances in Hematology & Oncology: ADC in Breast Cancer</a> </li></ul>

NEAREST SITE: 341 miles
Cedar-Sinai
Beverly Hills,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03530696

Antibody-Drug Conjugate T-DM1 and Palbociclib for Advanced HER2 Positive Breast Cancer

A Randomized Phase II Study to Evaluate Efficacy of T-DM1 With or Without Palbociclib in the Treatment of Patients With Metastatic HER2 Positive Breast Cancer Scientific Title

Purpose

To compare the side effects and effectiveness of the combination of trastuzumab emtansine/T-DM1 (Kadcyla®) and palbociclib (Ibrance®) to trastuzumab emtansine/T-DM1 (Kadcyla®) alone.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2-positive breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 2 weeks on, 1 week off </li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, once every 3 weeks </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks</li></ul>
<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 directly deliver the chemotherapy DM1 to the cancer cells.</li> <li class="seamTextUnorderedListItem">It is approved for patients with previously treated HER2-positive metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">Ibrance® is a CDK4/6 inhibitor approved to treat metastatic breast cancer when given along with hormone therapy--either letrozole (Femara®) or fulvestrant (Faslodex®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03530696' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cslide.ctimeetingtech.com/library/esmo/browse/search/258K#2F3503b' target='_blank'>ESMO: Palbociclib in combination with T-DM1 for metastatic HER2+ breast cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/RecommendedTreatmentsforMetastaticBreastCancer.html' target='_blank'>Susan G. Komen: Trastuzumab emtansine/T-DM1 (Kadcyla®)</a> </li></ul>

NEAREST SITE: 348 miles
University of Southern California
Los Angeles,CA

VISITS: 3 visits a month, ongoing

PHASE: II

NCT ID: NCT04225117

Targeted Therapy Enfortumab Vedotin in Advanced, HER2 Negative Breast Cancer

An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects With Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) Scientific Title

Purpose

To study the antitumor activity and effects (good and bad) of the experimental targeted therapy enfortumab vedotin (AGS-22CE).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV), HER2 negative (HER2-) breast cancer who have received chemotherapy for advanced or metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enfortumab vedotin (ASG-22CE), by IV, weekly (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enfortumab vedotin (ASG-22CE) is an antibody-drug conjugate. It combines an antibody that targets a specific protein on cancer cells (Nectin-4) with a chemotherapy that can kill them.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04225117' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-nectin-4-antibody-drug-conjugate-asg-22ce' target='_blank'>NCI Drug Dictionary: Enfortumab Vedotin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/monoclonal-antibodies' target='_blank'>Cancer Research UK: Monoclonal Antibodies</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.seagen.com/science/pipeline/enfortumab-vedotin' target='_blank'>Seagen Drug Information Page: Enfortumab Vedotin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.frontiersin.org/articles/10.3389/fmed.2019.00200/full' target='_blank'>Journal Article: Nectin-4 Expression Is an Independent Prognostic Biomarker and Associated With Better Survival in Triple-Negative Breast Cancer</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope
Duarte,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT04699630

Antibody-Drug Conjugate U3-1402 for Advanced HER2 Negative Breast Cancer

A Phase II Study of U3-1402 in Patients With Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, anti-cancer activity, and side effects of the investigational antibody-drug conjugate (ADC) U3-1402.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer. If your cancer is triple-negative (ER-, PR-, HER2-), you must have already received at least one but no more than three chemotherapies for metastatic disease. If your cancer is hormone-positive (ER+ and/or PR+), you must not have received more than two chemotherapies for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">U3-1402, by IV, every 3 weeks, ongoing</li></ul>
<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">U3-1402 is an investigational antibody-drug conjugate -- this means it is only available in clinical trials. </li> <li class="seamTextUnorderedListItem">U3-1402 targets HER3 to deliver chemotherapy directly to cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04699630' 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.cancer.gov/publications/dictionaries/cancer-drug/def/patritumab-deruxtecan' target='_blank'>NCI Drug Dictionary: U3-1402</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.annalsofoncology.org/article/S0923-7534(19)30419-3/fulltext' target='_blank'>Annals of Oncology: Single Agent Activity of U3-1402</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: 2 visits every 3 weeks, ongoing

PHASE: I

NCT ID: NCT02996825

Mirvetuximab Soravtansine & Chemotherapy in FRa+ Metastatic Triple Negative Breast Cancer

A Phase I Dose-Escalation Safety and Tolerability Study of Mirvetuximab Soravtansine (IMGN853) and Gemcitabine in Patients With FRa-positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial Cancer, or Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To test the safety and effects (good and bad) of a new drug called mirvetuximab soravtansine when it is given with the chemotherapy gemcitabine (Gemzar®).

Who is this for?

People with stage IV metastatic breast cancer that is triple negative (ER-, PR- and HER2-) and folate receptor (FR) alpha-positive. You must not have had more than four lines of chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mirvetuximab soravtansine, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Gemcitabine/Gemzar®, by IV, twice every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mirvetuximab soravtansine is an antibody drug conjugate (ADC). </li> <li class="seamTextUnorderedListItem">It uses a drug that targets folate receptors on cancer cells to deliver the chemotherapy soravtansine directly to the tumor. </li> <li class="seamTextUnorderedListItem">Gemzar® is a chemotherapy approved to treat metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of FR+ tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02996825' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/mirvetuximab-soravtansine' target='_blank'>NCI Dictionary: Mirvetuximab Soravtansine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/gemcitabine-hydrochloride' target='_blank'>NCI Dictionary: Gemcitabine Hydrochloride</a> </li></ul>

NEAREST SITE: 374 miles
Investigative Site
Orange,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04460456

SBT6050 for Advanced HER2 Expressing Breast Cancer

A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Expressing HER2 Scientific Title

Purpose

To study the best dose, safety, side effects and anti-cancer activity of the experimental targeted therapy SBT6050 alone and in combination with the immunotherapy pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 expressing (IHC 2+ or 3+) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SBT6050, by injection, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SBT6050, by injection, ongoing </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, ongoing</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 expressing cancer is IHC 2+ or 3+.</li> <li class="seamTextUnorderedListItem">SBT6050 is an antibody-drug conjugate (ADC). A type of cancer therapy that combines an antibody that targets cancer cells with a drug that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the drug does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">SBT6050 may also stimulate your immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2 expressing cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04460456' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://silverbacktx.com' target='_blank'>Silverback Therapeutics Drug Information Page: SBT6050</a> </li></ul>

NEAREST SITE: 390 miles
Emad Ibrahim, Md, Inc
Redlands,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT04740918

Antibody-Drug Conjugate T-DM1 and Immunotherapy for Advanced HER2+, PD-L1+ Breast Cancer

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (... Scientific Title

Purpose

To study the anti-cancer activity, safety, and side effects of giving trastuzumab emtansine/T-DM1 (Kadcyla®) with atezolizumab (Tecentriq®) to giving trastuzumab emtansine alone.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+), PD-L1 positive breast cancer. You must not have already received more than two chemotherapies for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Placebo for atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing</li></ul>
<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 — 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.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04740918' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: T-DM1 (Kadcyla®)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/atezolizumab.aspx' target='_blank'>Chemocare: Atezolizumab</a> </li></ul>

NEAREST SITE: 421 miles
Comprehensive Cancer Centers of Nevada
Las Vegas,NV

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04389632

SGN-B6A in Advanced Breast Cancer

A Phase 1 Study of SGN-B6A in Advanced Solid Tumors Scientific Title

Purpose

To study the safety, side-effects, anti-cancer activity, and best dose of the antibody-drug conjugate SGN-B6A.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-B6A, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-B6A is an investigational therapy. This means it is only available in a clinical trial.</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a cancer therapy that combines an antibody that targets cancer cells with a drug that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">SGN-B6A is an antibody-drug conjugate (ADC) targeting integrin beta-6. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced or metastatic cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04389632' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org' target='_blank'>Metastatic Breast Cancer Network</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biospace.com/article/releases/seattle-genetics-announces-initiation-of-phase-1-clinical-trials-for-two-novel-antibody-based-drug-candidates/' target='_blank'>BioSpace Press Release: Seagen Announces Initiation of Phase 1 Clinical Trials for Two Novel Antibody-Based Drug Candidates</a> </li></ul>

NEAREST SITE: 538 miles
Providence Cancer Institute
Portland,OR

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03602079

A166 for Advanced HER2 Positive and HER2 Low Expression Breast Cancer

A Phase I-II, FIH Study of A166 in Locally Advanced/Metastatic Solid Tumors Expressing Human Epidermal Growth Factor Receptor 2 (HER2) or Are HER2 Amplified That Did Not Respond or Stopped Responding to Approved Therapies Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of the experimental therapy A166.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low expression breast cancer that has not responded to standard therapies Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A166, by IV </li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A166 is a type of drug called an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">A166 combines chemotherapy with a HER2 targeted therapy, allowing it to deliver the chemotherapy directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or IHC 2+/ISH-</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03602079' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/795827' target='_blank'>NCI Drug Dictionary: A166</a> </li></ul>

NEAREST SITE: 538 miles
Providence
Portland,OR

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT04246671

Experimental Vaccine for Advanced HER2 Positive Breast Cancer

Phase 1/2 Expansion Cohorts Trial of Intravenous Administration of TAEK-VAC-HerBy Vaccine Alone and in Combination With HER2- and PD-1/PD-L1 Antibodies in Patients With Advanced HER2-expressing Cancer Scientific Title

Purpose

To study the safety, anti-cancer activity and effects (good and bad) of giving an experimental vaccine called TAEK-VAC-HerBy alone or in combination with other therapies.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have already received at least one therapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vaccine (TAEK-VAC-HerBy), by IV, every 3 weeks, 3 times</li> </ul> With or without one or more of the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV</li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®), by IV</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV</li> <li class="seamTextUnorderedListItem">a PD-1/PD-L1 inhibitor, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAEK-VAC-HerBy is the experimental vaccine used in this trial. Researchers believe it may stimulate the immune system to go after HER2 positive cancer cells.</li> <li class="seamTextUnorderedListItem">Other therapies you may receive during this trial include: trastuzumab (Herceptin®), T-DM1 (Kadcyla®), pertuzumab (Perjeta®), and a PD-1/PD-L1 inhibitor.</li> <li class="seamTextUnorderedListItem">Trastuzumab and pertuzumab are anti-HER2 targeted therapies commonly used to treat advanced HER2 positive breast cancer.</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> <li class="seamTextUnorderedListItem">PD-1/PD-L1 inhibitors are a type of immunotherapy. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04246671' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/taek-vac-herby-vaccine?redirect=true' target='_blank'>NCI Drug Dictionary: TAEK-VAC-HerBy Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/breast-cancer-treatment-vaccines/' target='_blank'>Metastatic Trial Talk: Breast Cancer Treatment Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/her2-positive-breast-cancer-research-update/' target='_blank'>Metastatic Trial Talk: HER2 Positive Metastatic Breast Cancer Research Update</a> </li></ul>

NEAREST SITE: 1454 miles
Research Site
Fort Worth,TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04538742

Trastuzumab Deruxtecan Alone and with Other Therapies for Advanced HER2-Positive Breast Cancer

A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07) Scientific Title

Purpose

To study the safety, side effects, and anti-cancer activity of giving the antibody-drug conjugate (ADC) trastuzumab deruxtecan (Enhertu®) alone and with other anti-cancer therapies.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2-positive (HER2+) breast cancer. You must have received already received at least one therapy for advanced disease. Full eligibility criteria

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What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 6 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) by IV, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, ongoing</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) by IV, ongoing</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> </ul> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by IV, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver chemotherapy directly to cancer cells. It is approved to treat some metastatic HER2+ breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 inhibitor. It works by stimulating the body's immune system to go after cancer cells. It is approved to treat some cancers, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) is a HER2-targeted therapy commonly used to treat HER2-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a HER2-targeted therapy. Research indicates it works against HER2+ breast cancer cells that have spread to the brain. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04538742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/enhertu' target='_blank'>Breastcancer.org: Enhertu® (Trastuzumab Deruxtecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/news/march-2021/updated-destiny-breast01-results-show-trastuzumab-deruxtecan-nxki-delivers-durable-responses/' target='_blank'>The ASCO Post: Miami Breast Cancer Conference, Updated DESTINY-Breast01 Results Show Trastuzumab Deruxtecan-nxki Delivers Durable Responses</a> </li></ul>

NEAREST SITE: 1454 miles
Research Site
Fort Worth,TX

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT04556773

Trastuzumab Deruxtecan with other Therapies for Advanced HER2-Low Breast Cancer

A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With Metastatic HER2-low Breast Cancer (DESTINY-Breast08) Scientific Title

Purpose

To study the anti-cancer activity, safety and side effects of giving trastuzumab deruxtican (Enhertu®) in combination with other therapies.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 low breast cancer. Full eligibility criteria

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What's involved?
What's being studied?
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You will be assigned to 1 of 5 groups and receive the following: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtican (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth (2 weeks on, 1 week off), ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtican (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every 3 weeks, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtican (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Capivasertib, by mouth, twice a day, ongoing</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtican (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily, ongoing</li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtican (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low breast cancer is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtican (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy drug directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">It is approved for use to treat people with metastatic HER2+ breast cancer who have already received two anti-HER2 therapies, but its use in this trial is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04556773' target='_blank'>ClinicalTrials.gov</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>

NEAREST SITE: 1481 miles
Mays Cancer Center, UT Health San Antonio
San Antonio,TX

VISITS: 2 visits every 3 weeks, ongoing

PHASE: NA

NCT ID: NCT03995706

Antibody Drug-Conjugate Sacituzumab Govitecan for Breast Cancer That Has Spread to the Brain

A Phase 0, Investigator Initiated Study to Determine the Bioavailability of Sacituzumab Govitecan in Breast Brain Metastasis and Glioblastoma Scientific Title

Purpose

To study if sacituzumab govitecan -- an antibody-drug conjugate -- crosses the blood-brain barrier to treat brain mets.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain and who are scheduled to have surgery to remove their brain tumors. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy), by IV, 1 day before surgery, then 2 times every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells. </li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. </li> <li class="seamTextUnorderedListItem">It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved for use in people with metastatic triple-negative breast cancer who have already received at least two other therapies for metastatic disease. But its use in this trial is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03995706' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Sacituzumab_govitecan' target='_blank'>Wikipedia: Sacituzumab Govitecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan-Hziy)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertodaymag.org/pages/Fall2015/Advances-Treating-Brain-Metastases.aspx' target='_blank'>Cancer Today: Breaking the Blood-Brain Barrier</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>MetastaticTrialTalk: Getting to the Target, Antibody Drug Conjugates in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nejm.org/doi/full/10.1056/NEJMoa1814213' target='_blank'>The New England Journal of Medicine: Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer</a> </li></ul>

NEAREST SITE: 1578 miles
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park,MN

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT04351230

Trastuzumab Emtansine/T-DM1 With or Without Abemaciclib for Advanced HER2 Positive Breast Cancer

Phase II Trial of Abemaciclib and T-DM1 in Women and Men With HER2-positive Advanced or Metastatic Breast Cancer Who Progressed on Treatment With a Taxane, Trastuzumab and Pertuzumab Scientific Title

Purpose

To study the anti-cancer activity of giving the antibody-drug conjugate trastuzumab emtansine/T-DM1 (Kadcyla®) alone or in combination with the CDK 4/6 inhibitor abemaciclib (Verzenio®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer. Full eligibility criteria

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What's being studied?
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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <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/T-DM1 (Kadcyla®) is an ADC. It combines the chemotherapy DM1 with the HER2 targeted therapy trastuzumab. </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a CDK 4/6 inhibitor that is commonly used to treat metastatic, hormone positive (ER+ and/or PR+) breast cancer. Its use in this trial is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04351230' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.kadcyla.com/patient/metastatic-breast-cancer.html' target='_blank'>Genentech Drug Information Page: Kadcyla® (Trastuzumab Emtansine)</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><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/november-10-2019/abemaciclib-benefits-patients-with-her2-positive-breast-cancer-in-monarcher-trial/' target='_blank'>ASCO Post: Abemaciclib Benefits Patients With HER2-Positive Breast Cancer</a> </li></ul>

NEAREST SITE: 1643 miles
MD Anderson ( Site 0001)
Houston,TX

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT04504916

Experimental Antibody-Drug Conjugate VLS-101 for Metastatic Breast Cancer

A Phase 2 Study of VLS-101 in Patients With Solid Tumors Scientific Title

Purpose

To study the safety, side effects and anti-cancer activity of the experimental antibody-drug conjugate (ADC) VLS-101.

Who is this for?

People with metastatic (stage IV) breast cancer who have already received at least one therapy for metastatic disease. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VLS-101, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VLS-101 is a type of 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 VLS-101 antibody targets ROR1, a protein that is expressed by breast cancer cells but not healthy cells, and it delivers the anti-cancer therapy monomethyl auristatin E. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04504916' 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://ashpublications.org/blood/article/134/Supplement_1/2856/423547/Vls-101-Is-a-Novel-Therapeutic-Antibody-Drug' target='_blank'>American Society of Hematology: VLS-101</a> </li></ul>

NEAREST SITE: 1643 miles
M.D. Anderson Cancer Center
Houston,TX

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT04450732

Anti-HER2 Targeted Therapy GQ1001 in Advanced HER2 Positive Breast Cancer

A Phase 1, First-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously, in Adult Patients With HER2-Positive Advanced Solid Tumors Scientific Title

Purpose

To study the best dose of GQ1001--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 who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GQ1001, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibody-drug conjugates are cancer therapies that combine an antibody that targets cancer cells with a drug that can kill cancer cells. </li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the drug does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">GQ1001 targets the HER2 protein on cancer cells. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2+ cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04450732' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.crconc.com/basic/press/press_20200713' target='_blank'>Press Release: GeneQuantum Healthcare Announces First Patient Dosed in Phase I Clinical Trial of GQ1001</a> </li></ul>

NEAREST SITE: 1857 miles
University of Chicago Medical Center
Chicago,IL

VISITS: 1 visit per week

PHASE: II

NCT ID: NCT04468061

Sacituzumab Govitecan with or without Pembrolizumab for Advanced Triple Negative or ER-Low, HER2- Breast Cancer

Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To study the safety and anti-cancer activity of giving the antibody-drug conjugate sacituzumab govitecan (Trodelvy) alone and in combination with the immunotherapy pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-. HER2-) or ER-Low (1%-10% ER), HER2 negative breast cancer that is PD-L1 negative, who have not yet started treatment for metastatic disease. Full eligibility criteria

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What's involved?
What's being studied?
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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells. </li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. </li> <li class="seamTextUnorderedListItem">It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved for use in people with metastatic triple negative breast cancer who have already received at least two other therapies for metastatic disease. But its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low. This trial is enrolling people with triple negative as well as ER-Low, HER2 negative breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04468061' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-sacituzumab-govitecan-triple-negative-breast-cancer' target='_blank'>NCI Cancer Currents Blog: Sacituzumab Govitecan Approved for Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/dosing' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/pembrolizumab' target='_blank'>Cancer Research UK: Pembrolizumab (Keytruda)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/lab-tests/pdl1-immunotherapy-tests/' target='_blank'>NIH MedlinePlus: PDL1 (Immunotherapy) Tests</a> </li></ul>

NEAREST SITE: 1857 miles
University of Chicago Medical Center
Chicago,IL

VISITS: 2 visits every 3 weeks

PHASE: II

NCT ID: NCT04448886

Sacituzumab Govitecan With or Without Pembrolizumab for Advanced HR+, HER2- Breast Cancer that is PD-L1+

Saci-IO HR+: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in Hormone Receptor-positive (HR+) / HER2- Metastatic Breast Cancer (MBC) Scientific Title

Purpose

To study the safety and anti-cancer activity of giving sacituzumab govitecan (Trodelvy) alone or with pembrolizumab (Keytruda®).

Who is this for?

People with locally advanced (some stage III) or metastatic (stage IV), hormone positive (ER+ and/or PR+), HER2 negative (HER2-), PD-L1 positive breast cancer who have not received more than one chemotherapy for metastatic disease. Full eligibility criteria

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What's involved?
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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, 2 out of every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, 2 out of every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells.</li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is approved for use in people with metastatic triple negative breast cancer who have already received at least two other therapies for metastatic disease but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PD-L1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04448886' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-sacituzumab-govitecan-triple-negative-breast-cancer' target='_blank'>NCI Cancer Currents Blog: Sacituzumab Govitecan Approved for Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/fda-approvals-sought-for-2-pembrolizumab-indications-in-tnbc' target='_blank'>OncLive: FDA Approvals Sought for 2 Pembrolizumab Indications in TNBC</a> </li></ul>

NEAREST SITE: 2265 miles
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh,PA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT04294628

Trastuzumab Deruxtecan for Advanced Breast Cancer that is HER2 Positive, HER2 Expressing or Tests Positive for a HER2 Mutation

Pilot Study of DS-8201a Pharmacodynamics in Patients With HER2-Expressing Advanced Solid Tumors Scientific Title

Purpose

To study the safety, anti-cancer activity and other effects (good and bad) of giving the antibody-drug conjugate fam-trastuzumab-deruxtican-nxki (Enhertu®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that is HER2 positive (HER2+), HER2 expressing (defined below) or positive for a HER2 mutation; and who have no standard of care treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fam-trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">2 biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 expressing (HER2 low expressing) tumors are defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">Some tumors test positive for a HER2 gene mutation. </li> <li class="seamTextUnorderedListItem">Fam-trastuzumab deruxtecan-nxki (Enhertu®) is an antibody-drug conjugate (ADC)--it uses a HER2 antibody to deliver a chemotherapy directly to cancer cells. It is approved for use in some people with metastatic HER2 positive breast cancer, but its use for HER2 expressing or HER2 mutated breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HER2 (ERBB2)</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04294628' target='_blank'>ClinicalTrials.gov</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 Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/enhertu' target='_blank'>Breastcancer.org: Fam-Trastuzumab-Deruxtecan-nxki</a> </li></ul>

NEAREST SITE: 2269 miles
Georgia Cancer Center at Augusta University
Augusta,GA

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT04300556

Experimental Antibody-Drug Conjugate MORAb-202 for Women with Metastatic Triple Negative Breast Cancer that Tests Positive for FRA

A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRÎ±)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types Scientific Title

Purpose

To study the safety, anti-cancer activity and side effects of giving the experimental antibody-drug conjugate MORAb-202.

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have already received a platinum-based chemotherapy and whose tumor tests positive for FRA. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MORAb-202, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <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. 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">MORAb-202 is an experimental ADC. </li> <li class="seamTextUnorderedListItem">Its antibody targets FAR, a protein, and it delivers an anti-cancer drug called eribulin mesylate.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling women with other types of cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: FRA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04300556' 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://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.5544' target='_blank'>Journal Article Abstract: MORAb-202</a> </li></ul>

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT04296942

Vaccine, Entinostat, Adotrastuzumab Emtansine and Bintrafusp Alfa for Metastatic HER2 Positive and Hormone Negative Breast Cancer

A Phase 1b Trial of Sequential Combinations of BN-Brachyury, Entinostat, Ado-trastuzuamb Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) Scientific Title

Purpose

To study the safety, anti-cancer activity and other effects (good and bad) of giving a combination of immunotherapies alone, with an antibody-drug conjugate, or with an antibody-drug conjugate and a targeted therapy.

Who is this for?

People with metastatic (stage IV), hormone negative (ER- and PR-) breast cancer who have already received at least one therapy for metastatic disease. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MVA-BN-Brachyury, by injection, every 3 weeks for 6 months, then every 3 months, ongoing </li> <li class="seamTextUnorderedListItem">FPV-BN-Brachyury, by injection, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">M7824 (bintrafusp alfa), by IV, every 3 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MVA-BN-Brachyury, by injection, every 3 weeks for 6 months, then every 3 months, ongoing </li> <li class="seamTextUnorderedListItem">FPV-BN-Brachyury, by injection, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">M7824 (bintrafusp alfa), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Ado-trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MVA-BN-Brachyury, by injection, every 3 weeks for 6 months, then every 3 months, ongoing </li> <li class="seamTextUnorderedListItem">FPV-BN-Brachyury, by injection, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">M7824 (bintrafusp alfa), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Ado-trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Entinostat, by mouth, once a week, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Brachyury injections are vaccines that researchers believe will help your immune system go after cancer cells. </li> <li class="seamTextUnorderedListItem">Bintrafusp alfa (M7824) is an investigational immunotherapy. It is designed to get the immune system to go after cancer cells by blocking the proteins PD-L1 and TGF-beta.</li> <li class="seamTextUnorderedListItem">Ado-trastuzumab emtansine (Kadcyla®) is an antibody-drug conjugate (ADC). It uses trastuzumab to deliver the chemotherapy DM1 directly to the cancer cells. It is approved to treat HER2 positive metastatic breast cancer, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Entinostat is an investigational targeted therapy called an HDAC inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04296942' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bavarian-nordic.com/what-we-do/cancer-immunotherapy/chordoma.aspx' target='_blank'>Bavarian Nordic Drug Information Page: BN-BRACHYURY</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/io-m7824/?cn-reloaded=1' target='_blank'>Immunotherapy-Oncology News: M7824(Bintrafusp Alfa)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/ado-trastuzumab-emtansine' target='_blank'>NCI Drug Dictionary: Ado-Trastuzumab Emtansine</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.syndax.com/pipeline/entinostat/' target='_blank'>Syndax Drug Information Page: Entinostat</a> </li></ul>

NEAREST SITE: 2685 miles
Massachusetts General Hospital at Newton-Wellesley Hospital
Newton,MA

VISITS: 1 visit every week for 3 months

PHASE: II

NCT ID: NCT04230109

Sacituzumab Govitecan Before Surgery for Stage I-III Triple Negative Breast Cancer

A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR) Scientific Title

Purpose

To study the anti-cancer activity and safety of the targeted therapy sacituzumab govitecan (Trodelvy) in early-stage triple negative breast cancer.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer who have not yet started treatment. Full eligibility criteria

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You will receive the following before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved for use in people with metastatic (stage IV) triple negative breast cancer. Its use in people with early stage triple negative breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">It is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan targets TROP2 proteins and delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04230109' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/treatment-of-triple-negative.html' target='_blank'>American Cancer Society: Treatment of Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/diagnosis/trip_neg' target='_blank'>Breastcancer.org: Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/patient/home' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sacituzumab-govitecan-hziy-metastatic-triple-negative-breast-cancer' target='_blank'>FDA Drug Approvals and Databases: Sacituzumab Govitecan-hziy for Metastatic TNBC</a> </li></ul>

NEAREST SITE: 2693 miles
Massachusetts General Hospital Cancer Center
Boston,MA

VISITS: Weekly visits for 2 out of every 3 weeks

PHASE: I-II

NCT ID: NCT04039230

Sacituzumab Govitecan and Talazoparib for Women With Metastatic Triple Negative Breast Cancer

Phase 1b/2 Study to Evaluate Antibody-Drug Conjugate Sacituzumab Govitecan in Combination With PARP Inhibitor Talazoparib in Patients With Metastatic Breast Cancer Scientific Title

Purpose

To evaluate the safety, best dose, and effects (good and bad) of using PARP inhibitor talazoparib (Talzenna®) in combination with sacituzumab govitecan (Trodelvy).

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy), by IV, once a week, for 2 out of every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The PARP inhibitor being used in this study is talazoparib (Talzenna®). It is approved for use in individuals with advanced triple-negative breast cancer and an inherited BRCA1 or BRCA2 mutation. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells. </li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. </li> <li class="seamTextUnorderedListItem">It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved to treat some metastatic triple-negative breast cancer, but its use in this trial is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04039230' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sacituzumab-govitecan' target='_blank'>NCI Drug Dictionary: Sacituzumab Govitecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/news/april-2020/fda-approves-sacituzumab-govitecan-hziy-for-patients-with-previously-treated-metastatic-triple-negative-breast-cancer/' target='_blank'>ASCO: FDA Approves Sacituzumab Govitecan-hziy for Patients With Previously Treated Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.immunomedics.com/sacituzumab-govitecan-immu-132/' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700039109819878' target='_blank'>Pfizer Oncology: Talzenna™</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>Metastatic Trial Talk: ADCs in Breast Cancer</a> </li></ul>