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1

BBO-10203 Targeted Therapy with <span class="highlight">Trastuzumab</span> for Advanced HER2+ or HR+, HER2- Breast Cancer

A Phase 1a/1b Study of the PI3Kα:RAS Breaker BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)

Purpose: To study the safety, best dose, and effects (good and bad) of BBO-10203, an experimental targeted therapy, with <span class="highlight">trastuzumab</span> (Herceptin®) anti-HER2 targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received at least 2 lines of anti-HER2 targeted therapy or hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BBO-10203, by mouth, daily</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV, weekly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BBO-10203 is an experimental targeted therapy called a PI3Kα/AKT inhibitor. Blocking PI3Kα and AKT may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06625775' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://bridgebiooncology.com/platform/' target='_blank'>BridgeBio: BBO-10203 Drug Information Page</a> </li></ul>
1

BBO-10203 Targeted Therapy with <span class="highlight">Trastuzumab</span> for Advanced HER2+ or HR+, HER2- Breast Cancer

A Phase 1a/1b Study of the PI3Kα:RAS Breaker BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)
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Nearest Location:
3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, CA

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Visits:
At least 1 visit every week

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ClinicalTrials.gov: NCT06625775

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Phase I

2

Choosing Targeted Therapy Based on a Tumor's Genetic Makeup for Advanced Breast Cancer (TAPUR)

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of using a tumor's genetic profile to select an FDA-approved targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with no standard treatment options. You must have results from a genomic or immunohistochemistry test approved by TAPUR. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive an FDA-approved targeted therapy based on your tumor's genetic profile.</p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy you receive will be selected based on your tumor's genetic profile.</li> <li class="seamTextUnorderedListItem">Your treatment may include one or more of the following: Abemaciclib, Futibatinib, Nivolumab, Ipilimumab, Olaparib, Palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, <span class="highlight">Trastuzumab,</span> Pertuzumab, Vemurafenib, Cobimetinib</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ALK, ATM, BRAF, BRAF V600E/D/K/R, BRCA1/2, CDK4, CDK6, CDKN2A, CSF1R, FGFR1/2/3/4, HER2 (ERBB2), high mutational load and others, KIT, MET, MSI-H, mTOR, NRG1, PALB2, PDGFR, POLD1, POLE, RAF-1, RET, ROS1, TSC, VEGFR</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02693535' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.tapur.org/' target='_blank'>ASCO: TAPUR Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/clinical-trials/what-tapur-study' target='_blank'>Cancer.Net (Video): What is the TAPUR Study?</a> </li><li class='seamTextUnorderedListItem'><a href='https://old-prod.asco.org/research-data/tapur-study/study-participation' target='_blank'>ASCO: TAPUR Study Participation</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/conference-coverage/asco-2016/dr-edward-kim-on-ascos-tapur-trial' target='_blank'>OncLive (Video): About TAPUR</a> </li></ul>
2

Choosing Targeted Therapy Based on a Tumor's Genetic Makeup for Advanced Breast Cancer (TAPUR)

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study
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Nearest Location:
3 miles
Kaiser Permanente - San Francisco Medical Center
San Francisco, CA

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Visits:
Coincides with targeted therapy

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ClinicalTrials.gov: NCT02693535

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Phase II

3

Zanidatamab Targeted Therapy with Chemotherapy for Advanced HER2 Positive Breast Cancer

A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to <span class="highlight">Trastuzumab</span> in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, o...

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of zanidatamab, an experimental anti-HER2 targeted therapy, with chemotherapy compared to <span class="highlight">trastuzumab</span> (Herceptin®) anti-HER2 targeted therapy with chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®, T-DXd). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab, by IV</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 1-2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 1-2 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab is an experimental targeted therapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to 2 distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">Zanidatamab is a bispecific antibody that binds to 2 targets on HER2.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, the chemotherapy drugs are eribulin (Halaven®), gemcitabine (Gemzar®), vinorelbine (Navelbine®), or capecitabine (Xeloda®).</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06435429' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/zanidatamab-combo-appears-exciting-in-her2-hr-metastatic-breast-cancer' target='_blank'>CancerNetwork: Zanidatamab Combo Appears ‘Exciting’ in HER2+/HR+ Metastatic Breast Cancer</a> </li></ul>
3

Zanidatamab Targeted Therapy with Chemotherapy for Advanced HER2 Positive Breast Cancer

A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to <span class="highlight">Trastuzumab</span> in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, o...
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Nearest Location:
3 miles
UCSF at Mission Bay MB
San Francisco, CA

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Visits:
Approximately 1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT06435429

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Phase III

4

Disitamab Vedotin Antibody Drug Conjugate for Advanced HER2 Low or HER2+ Breast Cancer

A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination With Other Anticancer Therapies in Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of disitamab vedotin, an experimental antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 low or HER2 positive (HER2+) breast cancer who have received <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®) or sacituzumab govitecan (Trodelvy®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Disitamab vedotin</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Disitamab vedotin</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Disitamab vedotin is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody targets cancer cells, the ADC does minimal damage to normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in disitamab vedotin targets HER2 proteins. It delivers the chemotherapy MMAE.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06157892' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct06157892-breast-neoplasms-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://players.brightcove.net/1852113022001/7eDMrqTZyS_default/index.html?videoId=6353406732112' target='_blank'>Pfizer: ADC Video</a> </li></ul>
4

Disitamab Vedotin Antibody Drug Conjugate for Advanced HER2 Low or HER2+ Breast Cancer

A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination With Other Anticancer Therapies in Solid Tumors
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Nearest Location:
3 miles
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06157892

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Phase II

5

Tumor Test to Predict Response to Enhertu® for People with Metastatic HER2 Low Breast Cancer

QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer

Purpose: To study the ability of the CE-10-IVD test to predict treatment response to <span class="highlight">trastuzumab</span> deruxtecan (T-DXd, Enhertu®).

Who is this for?: People with stage IV (metastatic) HER2 low (IHC 1+) breast cancer who are planning to receive or are receiving (within 1 month) <span class="highlight">trastuzumab</span> deruxtecan (T-DXd, Enhertu®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor tissue from most recent biopsy, for CE-10-IVD test</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The CE-10-IVD test measures the amount of HER2 positive (HER2+) breast cancer cells, which may relate to your response to <span class="highlight">trastuzumab</span> deruxtecan (T-DXd, Enhertu®), an anti-HER2 targeted therapy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06551116' target='_blank'>ClinicalTrials.gov</a> </li></ul>
5

Tumor Test to Predict Response to Enhertu® for People with Metastatic HER2 Low Breast Cancer

QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
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Nearest Location:
3 miles
University of California San Francisco Medical Center
San Francisco, CA

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Visits:
Coincides with routine care

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ClinicalTrials.gov: NCT06551116

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Phase NA

6

Sequence of Two ADCs for Advanced HER2 Low Breast Cancer

A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or <span class="highlight">Trastuzumab</span> Deruxtecan (T-DXd) in Patients with Metastatic HER2-low Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy (TRADE DXd)

Purpose: To test the safety and effectiveness of the sequence of 2 types of antibody drug conjugates (ADCs) to learn whether the treatment works for people with metastatic HER2 low breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 low breast cancer. You must not have received more than 2 lines of chemotherapy or antibody drug conjugates for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (T-DXd, Enhertu®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> followed by (after progression): </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">CT scans, every 2 months</li> <li class="seamTextUnorderedListItem">MRI scans, every 2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> followed by (after progression): </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (T-DXd, Enhertu®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">CT scans, every 2 months</li> <li class="seamTextUnorderedListItem">MRI scans, every 2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®) and datopotamab deruxtecan (Dato-DXd) are antibody drug conjugates (ADCs).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd)'s antibody targets TROP2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">The US FDA has not approved datopotamab deruxtecan as a treatment for HER2-low metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">The US FDA has approved <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®) for previously treated HER2-low metastatic breast cancer, and for other uses.</li> <li class="seamTextUnorderedListItem">If you are randomized to a group and have already received the first drug, you may immediately skip to the second drug.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06533826' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
6

Sequence of Two ADCs for Advanced HER2 Low Breast Cancer

A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or <span class="highlight">Trastuzumab</span> Deruxtecan (T-DXd) in Patients with Metastatic HER2-low Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy (TRADE DXd)
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Nearest Location:
3 miles
University of San Francisco
San Francisco, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT06533826

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Phase II

7

Carvedilol to Prevent Heart Problems in People with Metastatic HER2+ Breast Cancer

Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients With Metastatic HER-2+ Breast Cancer, Phase III

Purpose: To investigate whether a beta-blocker can help prevent heart problems caused by cancer treatments.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who are receiving or planning to receive <span class="highlight">trastuzumab</span> (Herceptin®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Intervention</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carvedilol, by mouth, daily for up to 2 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No intervention</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: If you are already taking taking a beta blocker, ARB, or ACE inhibitor</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Observation for up to 2 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity. </li> <li class="seamTextUnorderedListItem">The beta-blocker being used in this study is carvedilol. It is used to treat heart failure and high blood pressure.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03418961' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/side_effects/heart_probs' target='_blank'>Breastcancer.org: Heart Problems</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.health.harvard.edu/heart-health/treatments-for-breast-cancer-may-harm-the-heart' target='_blank'>Harvard Health Publishing: Treatments for Breast Cancer</a> </li></ul>
7

Carvedilol to Prevent Heart Problems in People with Metastatic HER2+ Breast Cancer

Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients With Metastatic HER-2+ Breast Cancer, Phase III
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Nearest Location:
22 miles
Contra Costa Regional Medical Center
Martinez, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT03418961

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Phase III

8

Inavolisib and Phesgo for Advanced HER2 Positive Breast Cancer with a PIK3CA Mutation

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer...

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of inavolisib, an experimental PI3K inhibitor, with Phesgo anti-HER2 targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer with a PIK3CA mutation who have not received treatment for advanced disease (except for hormone therapy if HR+). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy (optional, if relevant)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for inavolisib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy (optional, if relevant)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will first receive induction therapy (initial therapy used when treating a disease) with Phesgo and chemotherapy.</li> <li class="seamTextUnorderedListItem">Inavolisib is an experimental targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Phesgo is a combination of two anti-HER2 targeted therapies: Perjeta® (pertuzumab) and Herceptin® <span class="highlight">(trastuzumab).</span> It also includes a protein called hyaluronidase which helps your body absorb the targeted therapies.</li> <li class="seamTextUnorderedListItem">Pertuzumab and <span class="highlight">trastuzumab</span> are typically given by IV. With Phesgo, you can receive these therapies by injection, which shortens the length of time it takes to receive treatment.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05894239' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/medical-professionals/pipeline/inavolisib-gdc-0077' target='_blank'>Genentech: Inavolisib Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/phesgo' target='_blank'>Breastcancer.org: Phesgo</a> </li></ul>
8

Inavolisib and Phesgo for Advanced HER2 Positive Breast Cancer with a PIK3CA Mutation

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer...
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Nearest Location:
186 miles
Renown Regional Medical Center
Reno, NV

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05894239

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Phase III

9

Targeted Therapy for HER2 Positive Stage II-IV Breast Cancer

A Phase 1B Trial Evaluating the Safety of Ribociclib, Tucatinib, and <span class="highlight">Trastuzumab</span> in Patients With Metastatic, HER2+ Breast Cancer and a Multicenter, Randomized, Open-Label, Phase 2 Study of Preoperative Treatment With Ribociclib,Ttrastuzumab, Tucatinib, and Fulvestrant Versus Docetaxel, Carboplatin,Ttrastuzumab, and Pertuzumab in HR+/HER2+ Breas...

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ribociclib (Kisqali®), <span class="highlight">trastuzumab</span> (Herceptin®), and tucatinib (Tukysa®) targeted therapies alone or with fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with stage II, stage III, or stage IV (metastatic) HER2 positive (HER2+) or HER2 low breast cancer. If you have stage II or some stage III breast cancer, you must not have received treatment or surgery. If you have advanced (some stage III) or metastatic (stage IV) breast cancer, you must have received at least 1 line of anti-HER2 targeted therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on your type of cancer: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. It blocks two enzymes, CDK 4 and CDK 6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05319873' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
9

Targeted Therapy for HER2 Positive Stage II-IV Breast Cancer

A Phase 1B Trial Evaluating the Safety of Ribociclib, Tucatinib, and <span class="highlight">Trastuzumab</span> in Patients With Metastatic, HER2+ Breast Cancer and a Multicenter, Randomized, Open-Label, Phase 2 Study of Preoperative Treatment With Ribociclib,Ttrastuzumab, Tucatinib, and Fulvestrant Versus Docetaxel, Carboplatin,Ttrastuzumab, and Pertuzumab in HR+/HER2+ Breas...
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Nearest Location:
336 miles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, CA

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Visits:
1 visit every week

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ClinicalTrials.gov: NCT05319873

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Phase I-II

10

OKI-219 Targeted Therapy for Advanced HR+ Breast Cancer with PI3K Mutations

PIKture-01: First-in-Human Study of the PI3KÃŽ±H1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and in Combination With Endocrine Therapy or HER2-Targeted Therapy in Participants With Advanced Breast Cancer (PIKture-01)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of OKI-219, an experimental PI3Kα inhibitor, with fulvestrant (Faslodex®) hormone therapy or <span class="highlight">trastuzumab</span> (Herceptin®) anti-HER2 targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 positive (HER2+) breast cancer with a PI3KαH1047R mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: HR positive, HER2 negative</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OKI-219, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: HER2 positive</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OKI-219, by mouth, daily</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PI3KαH1047R is a common type of PI3KCA mutation.</li> <li class="seamTextUnorderedListItem">OKI-219 is an experimental targeted therapy called a PI3Kα inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated which allows cancer cells to grow. OKI-219 may block the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy called a selective estrogen receptor degraders (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06239467' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://onkuretherapeutics.com/pipeline/' target='_blank'>OnKure: OKI-219 Drug Information Page</a> </li></ul>
10

OKI-219 Targeted Therapy for Advanced HR+ Breast Cancer with PI3K Mutations

PIKture-01: First-in-Human Study of the PI3KÃŽ±H1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and in Combination With Endocrine Therapy or HER2-Targeted Therapy in Participants With Advanced Breast Cancer (PIKture-01)
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Nearest Location:
339 miles
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06239467

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Phase I

11

MGC026 Antibody Drug Conjugate for Advanced Breast Cancer

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of MGC026, an experimental antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have not received <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGC026, by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGC026 is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">MGC026's antibody targets B7-H3, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06242470' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://macrogenics.com/pipeline/mgc026/' target='_blank'>MacroGenics: MGC026 Drug Information Page</a> </li></ul>
11

MGC026 Antibody Drug Conjugate for Advanced Breast Cancer

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors
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Nearest Location:
339 miles
The Angeles Clinic and Research Institute
Los Angeles, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT06242470

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Phase I

12

Zongertinib Targeted Therapy with ADC for Advanced HER2+ Breast Cancer

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) in Combination With Intravenous <span class="highlight">Trastuzumab</span> Deruxtecan (T-DXd) or in Combination With Intravenous <span class="highlight">Trastuzumab</span> Emtansine (T-DM1) for Treatment of Patients With Advanced HER2+ Metastatic Breast Cance...

Purpose: To find a dose of zongertinib, an experimental targeted therapy, that people with advanced HER2+ breast cancer can tolerate best when taken with <span class="highlight">trastuzumab</span> deruxtecan (T-DXd, Enhertu®) or <span class="highlight">trastuzumab</span> emtansine (T-DM1, Kadcyla®) antibody drug conjugates.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zongertinib (BI 1810631), by mouth</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> emtansine (T-DM1, Kadcyla®), by IV</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zongertinib (BI 1810631), by mouth</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (T-DXd, Enhertu®), by IV</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zongertinib is an experimental anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®) and <span class="highlight">trastuzumab</span> emtansine (T-DM1, Kadcyla®) are antibody drug conjugates (ADCs).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®)'s antibody targets HER2 and delivers an anti-cancer drug called DM1.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06324357' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/?_gl=1*msj5sm*_ga*NDI3ODYxOTY5LjE2NzE2MzcwODA.*_ga_Y9F235S3X2*MTcxMDc3NDgwNy40MTEuMS4xNzEwNzc2MTM5LjQ2LjAuMA..' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.boehringer-ingelheim.com/science/human-pharma/clinical-pipeline/oncology/zongertinib-her2-tyrosine-kinase-inhibitor-tki' target='_blank'>Boehringer Ingelheim: Zongertinib (BI 1810631) Drug Information Page</a> </li></ul>
12

Zongertinib Targeted Therapy with ADC for Advanced HER2+ Breast Cancer

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) in Combination With Intravenous <span class="highlight">Trastuzumab</span> Deruxtecan (T-DXd) or in Combination With Intravenous <span class="highlight">Trastuzumab</span> Emtansine (T-DM1) for Treatment of Patients With Advanced HER2+ Metastatic Breast Cance...
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Nearest Location:
340 miles
Valkyrie Clinical Trials
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06324357

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Phase I-II

13

TransCon IL-2 β/γ Immunotherapy with <span class="highlight">Trastuzumab</span> or <span class="highlight">Trastuzumab</span> Emtansine (T-DM1) for Metastatic 3rd Line or Later HER2+ Breast Cancer

IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

Purpose: To study the safety, best dose, and effects (good and bad) of TransCon IL-2 β/γ, an experimental immunotherapy, alone or with other anti-cancer therapies.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received at least 2 lines of therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TransCon IL-2 β/γ, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®) or <span class="highlight">Trastuzumab</span> emtansine (T-DM1, Kadcyla®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TransCon IL-2 β/γ is an experimental immunotherapy that includes interleukin-2 (IL-2) and may work better than IL-2 alone.</li> <li class="seamTextUnorderedListItem">IL-2 activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®) is an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An ADC is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">T-DM1's antibody targets HER2 and delivers an anti-cancer drug called emtansine.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05081609' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascendispharma.com/pipeline/oncology/' target='_blank'>Ascendis Pharma: TransCon Drug Information Page</a> </li></ul>
13

TransCon IL-2 β/γ Immunotherapy with <span class="highlight">Trastuzumab</span> or <span class="highlight">Trastuzumab</span> Emtansine (T-DM1) for Metastatic 3rd Line or Later HER2+ Breast Cancer

IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
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Nearest Location:
340 miles
Ascendis Pharma Investigational Site
Los Angeles, CA

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Visits:
At least 1 visit every 3 weeks

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ClinicalTrials.gov: NCT05081609

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Phase I-II

14

BL-M07D1 ADC for Advanced HER2 Positive, HER2 Low, and HER2 Expressing Breast Cancer

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of BL-M07D1, an experimental antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+), HER2 low, or HER2 amplified breast cancer who have received at least 2 lines of therapy. You are also eligible if circulating tumor cells (CTCs) are HER2 amplified. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BL-M07D1, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BL-M07D1 is an experimental targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">BL-M07D1's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called <span class="highlight">trastuzumab.</li></span> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06293898' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://systimmune.com/bl-m07d1' target='_blank'>SystImmune: BL-M07D1 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
14

BL-M07D1 ADC for Advanced HER2 Positive, HER2 Low, and HER2 Expressing Breast Cancer

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors
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Nearest Location:
341 miles
Cedars Sinai
Los Angeles, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT06293898

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Phase I

15

Patritumab Deruxtecan ADC Compared to Chemotherapy or <span class="highlight">Trastuzumab</span> Deruxtecan for Advanced HR+, HER2- Breast Cancer

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of patritumab deruxtecan antibody-drug conjugate (ADC) compared to chemotherapy or <span class="highlight">trastuzumab</span> deruxtecan (T-DXd; Enhertu®) ADC.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer whose cancer has progressed while receiving a CDK4/6 inhibitor and hormone therapy. You must not have a BRCA mutation and be eligible for treatment with a PARP inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan, by IV, every 3 weeks for 13 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy or <span class="highlight">trastuzumab</span> deruxtecan (T-DXd; Enhertu®), for 13 months</li></ul>

What's being studied?

<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. Patritumab deruxtecan is an ADC that binds to HER3, which is found on many breast cancer cells.</li> <li class="seamTextUnorderedListItem">For participants in the control group, the schedule for receiving the drug will vary depending on the drug.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07060807' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.merck.com/research/product-pipeline/' target='_blank'>Merck: Patritumab deruxtecan</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></ul>
15

Patritumab Deruxtecan ADC Compared to Chemotherapy or <span class="highlight">Trastuzumab</span> Deruxtecan for Advanced HR+, HER2- Breast Cancer

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)
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Nearest Location:
346 miles
Los Angeles Hematology Oncology Medical Group ( Site 0026)
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT07060807

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Phase III

16

Sacituzumab Govitecan ADC at a Different Dose and Schedule in Advanced Triple Negative Breast Cancer

A Phase 1/2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of a different dose and schedule of sacituzumab govitecan (Trodelvy), an antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not yet received treatment for advanced disease. Your tumors must be PD-L1 negative, or you must have received treatment with pembrolizumab (Keytruda) or atezolizumab (Tecentriq®) immunotherapy for early stage disease. You must not have received treatment with <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®) or sacituzumab govitecan (Trodelvy®) ADCs or irinotecan (Camptosar®) chemotherapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is FDA approved for advanced triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">This trial is studying a new way to give sacituzumab govitecan (Trodelvy®).</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers a chemotherapy drug to cancer cells with TROP2.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06926920' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
16

Sacituzumab Govitecan ADC at a Different Dose and Schedule in Advanced Triple Negative Breast Cancer

A Phase 1/2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
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Nearest Location:
346 miles
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06926920

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Phase I-II

17

PET/MRI Scan to Determine Response to Treatment for People with Metastatic HER2+ Breast Cancer with Brain or Leptomeninges Metastasis

Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan

Purpose: To find HER2+ breast cancer that has spread to the brain and predict response to treatment with <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®), an antibody drug conjugate (ADC).

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain or leptomeninges (brain or leptomeningeal metastasis) who are planning to receive treatment with <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">64Cu-DOTA-trastuzumab, by IV, 1 time</li> <li class="seamTextUnorderedListItem">PET/MRI scan, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI scan, every 1.5 months for 6 months, then every 2 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (Enhertu®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">64Cu-DOTA-trastuzumab is an experimental tracer that detects cancer cells during imaging scans.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive tracer to look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy.</li> <li class="seamTextUnorderedListItem">The results of your PET/MRI scan will find the cancer in your brain and may predict your response to treatment.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a type of anti-HER2 targeted therapy used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05376878' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cedars-sinai.org/programs/imaging-center/exams/nuclear-medicine/pet-mri.html' target='_blank'>Cedars-Sinai: PET/MRI Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab deruxtecan (Enhertu®)</a> </li></ul>
17

PET/MRI Scan to Determine Response to Treatment for People with Metastatic HER2+ Breast Cancer with Brain or Leptomeninges Metastasis

Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan
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Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

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Visits:
1 visit every 1-2 months

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ClinicalTrials.gov: NCT05376878

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Phase IV

18

Valemetostat Tosylate Targeted Therapy with ADC for Advanced HER2 Low Breast Cancer

A Phase 1b, Multicenter, Open-Label Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of valemetostat tosylate, an experimental targeted therapy, with <span class="highlight">trastuzumab</span> deruxtecan (T-DXd, Enhertu®) antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 low breast cancer who have received 1-2 lines of chemotherapy for advanced disease. You must not have received anti-HER2 targeted therapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Valemetostat tosylate, by mouth, daily</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (T-DXd, Enhertu®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Valemetostat tosylate is an experimental targeted therapy called a EZH1/2 inhibitor. Blocking EZH1/2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®) is an antibody drug conjugate (ADCs).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06244485' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.daiichisankyo.com/rd/pipeline/' target='_blank'>Daiichi Sankyo: Valemetostat Tosylate Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li></ul>
18

Valemetostat Tosylate Targeted Therapy with ADC for Advanced HER2 Low Breast Cancer

A Phase 1b, Multicenter, Open-Label Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
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Nearest Location:
386 miles
City of Hope At Orange County Lennar Foundation Cancer Center
Irvine, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT06244485

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Phase I

19

ENV-501 Antibody Drug Conjugate for Advanced HR+, HER2-, HER3+ Breast Cancer

A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ENV-501, an experimental antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), HER3 positive (HER3+) breast cancer who have no standard treatment options available. You must not have received <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®) as your most recent line of therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ENV-501, by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ENV-501 is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody targets cancer cells, the ADC does minimal damage to normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in disitamab vedotin targets HER3 proteins. It delivers the chemotherapy exatecan.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06956690' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://endeavorbiomedicines.com/our-science/env-501/' target='_blank'>Endeavor Biomedicines: ENV-501 Drug Information Page</a> </li></ul>
19

ENV-501 Antibody Drug Conjugate for Advanced HR+, HER2-, HER3+ Breast Cancer

A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors
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Nearest Location:
441 miles
Research Site
La Jolla, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT06956690

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Phase I-II

20

Zanidatamab Targeted Therapy for Advanced HER2 Positive Breast Cancer

A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of zanidatamab, an experimental targeted therapy.

Who is this for?: People with advanced HER2 positive (HER2+ (IHC3+)) breast cancer who have received <span class="highlight">trastuzumab</span> deruxtecan (T-DXd, Enhertu®) and have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab, by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab (ZW25) is an experimental anti-HER2 targeted therapy and bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 positive is IHC 3+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06695845' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zymeworks.com/pipeline#zanidatamab' target='_blank'>Zymeworks Drug Information Page: Zanidatamab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/dr-montero-on-zanidatamab-and-evorpacept-in-her2-expressing-metastatic-breast-cancer' target='_blank'>OncLive: Zanidatamab for Metastatic HER2+ Breast Cancer</a> </li></ul>
20

Zanidatamab Targeted Therapy for Advanced HER2 Positive Breast Cancer

A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)
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Nearest Location:
597 miles
Arizona Oncology Associates, PC - NAHOA
Prescott, AZ

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06695845

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Phase II

21

Exercise for Fatigue for People with Advanced Breast Cancer Receiving <span class="highlight">Trastuzumab</span> Deruxtecan

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study

Purpose: To study the safety and effects (good and bad) of a home-based, unsupervised exercise program for cancer-related fatigue.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+), HER2-low, or hormone receptor-positive (HR+), HER2-low or HER2-ultralow breast cancer who are receiving <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®) and experiencing fatigue. You must not be participating in an exercise program as defined by the study investigators. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exercise program, at home, for 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Physical function tests</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Usual Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No exercise</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Physical function tests</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The exercise program is an individualized, home-based, unsupervised, whole-body resistance training and aerobic exercise program.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07203378' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/special-topics/enhertu-hrpos-her2low/' target='_blank'>Metastatic Trial Talk: Trastuzumab Deruxtecan (Enhertu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/fatigue-2/' target='_blank'>Metastatic Trial Talk: Fatigue</a> </li></ul>
21

Exercise for Fatigue for People with Advanced Breast Cancer Receiving <span class="highlight">Trastuzumab</span> Deruxtecan

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu: A Single-Center Pilot Study
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Nearest Location:
602 miles
Huntsman Cancer Institute at University of Utah
Salt Lake City, UT

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Visits:
Number of visits unavailable, 3 months

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ClinicalTrials.gov: NCT07203378

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Phase II

22

GI-102 Bispecific Antibody Alone or With Immunotherapy for Advanced Breast Cancer

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or <span class="highlight">Trastuzumab</span> Deruxtecan(T-DXd) in Patient...(KEYNOTE-G08)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of GI-102, an experimental bispecific antibody, alone or with other anti-cancer drugs.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 5 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV or injection, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (Enhertu®, T-DXd), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 1-3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, every 2 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102 is an experimental immunotherapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two different targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd) is an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">The chemotherapies being used in this study are doxorubicin (Doxil®), paclitaxel (Taxol®), and eribulin (Halaven®).</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®) is a targeted therapy called a VEGF inhibitor. Blocking VEGF may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05824975' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/bispecific-antibodies-for-mbc/' target='_blank'>Metastatic Trial Talk: Bispecific Antibodies: An Emerging Class Of MBC Drugs</a> </li></ul>
22

GI-102 Bispecific Antibody Alone or With Immunotherapy for Advanced Breast Cancer

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or <span class="highlight">Trastuzumab</span> Deruxtecan(T-DXd) in Patient...(KEYNOTE-G08)
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Nearest Location:
660 miles
Mayo Clinic in Arizona
Scottsdale, AZ

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Visits:
At least 1 visit every 3 weeks

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ClinicalTrials.gov: NCT05824975

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Phase I-II

23

Targeted Therapy and Chemotherapy for Advanced HER2+ Breast Cancer

A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination With Eribulin and <span class="highlight">Trastuzumab</span> in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of <span class="highlight">trastuzumab</span> (Herceptin®) anti-HER2 targeted therapy, tucatinib (Tukysa®) tyrosine kinase inhibitor, and eribulin (Halaven®) chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received treatment with <span class="highlight">trastuzumab</span> (Herceptin®) and chemotherapy for advanced/metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug approved to treat metastatic breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05458674' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/halaven' target='_blank'>Breastcancer.org: Eribulin (Halaven®)</a> </li></ul>
23

Targeted Therapy and Chemotherapy for Advanced HER2+ Breast Cancer

A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination With Eribulin and <span class="highlight">Trastuzumab</span> in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer
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Nearest Location:
679 miles
Swedish Cancer Institute
Issaquah, WA

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Visits:
1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT05458674

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Phase II

24

Sulforaphane Nutritional Supplement to Reduce Heart Problems from Doxorubicin Chemotherapy

Phase II Trial of Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction (CRI18-026)

Purpose: To study if sulforaphane (Avmacol®) reduces heart problems caused by doxorubicin (Adriamycin®) chemotherapy.

Who is this for?: People with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive doxorubicin (Adriamycin®) chemotherapy. You must not have received radiation to your chest, and if your tumor is HER2-positive, you must not be receiving <span class="highlight">trastuzumab</span> (Herceptin®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sulforaphane (Avmacol®), by mouth, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood tests, 7 times in 1 year</li> <li class="seamTextUnorderedListItem">Heart function tests, 2 times in 1 year</li> <li class="seamTextUnorderedListItem">PET scan, 3 times in 1 year</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Placebo</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for sulforaphane (Avmacol®), by mouth, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood tests, 7 times in 1 year</li> <li class="seamTextUnorderedListItem">Heart function tests, 2 times in 1 year</li> <li class="seamTextUnorderedListItem">PET scan, 3 times in 1 year</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®) is a chemotherapy commonly used to treat breast cancer. It can cause injury to the heart in about 10-20% of patients.</li> <li class="seamTextUnorderedListItem">There is a need to develop new strategies that prevent the harmful effects of doxorubicin (Adriamycin®) but maintain its effectiveness as a cancer therapy.</li> <li class="seamTextUnorderedListItem">Sulforaphane (Avmacol®) is an experimental dietary supplement derived from broccoli and other cruciferous vegetables. It may keep normal cells healthy and enhance cancer cell sensitivity to doxorubicin (Adriamycin®).</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03934905' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/adriamycin' target='_blank'>Breastcancer.org: Doxorubicin (Adriamycin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.avmacol.com/' target='_blank'>Nutramax Laboratories: Sulforaphane (Avmacol®)</a> </li></ul>
24

Sulforaphane Nutritional Supplement to Reduce Heart Problems from Doxorubicin Chemotherapy

Phase II Trial of Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction (CRI18-026)
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Nearest Location:
1185 miles
Texas Tech University Health Sciences Center
Lubbock, TX

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Visits:
At least 7 visits within 1 year

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ClinicalTrials.gov: NCT03934905

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Phase I-II

25

Evorpacept Targeted Therapy with Standard of Care Treatment for Advanced HER2+ Breast Cancer

ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of evorpacept, an experimental targeted therapy, with standard of care treatment compared to standard of care treatment alone.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®, T-DXd). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evorpacept, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evorpacept is an experimental targeted therapy called a CD47 inhibitor that allows immune cells to attack and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">This study is enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07007559' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://alxoncology.com/our-approach/evorpacept/' target='_blank'>ALX Oncology: Evorpacept Drug Information Page</a> </li></ul>
25

Evorpacept Targeted Therapy with Standard of Care Treatment for Advanced HER2+ Breast Cancer

ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies
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Nearest Location:
1414 miles
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, NE

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT07007559

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Phase I-II

26

Chemotherapy Treatment At Home for People with Advanced Breast Cancer

Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic

Purpose: To compare the safety and effects (good and bad) of receiving paclitaxel (Taxol®) chemotherapy at home and at a clinic.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who are receiving chemotherapy, <span class="highlight">trastuzumab</span> (Herceptin®), leuprolide (Lupron®), or goserelin (Zoladex®). You must live within 35 miles from Mayo Clinic in Jacksonville, FL. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Treatment At Home</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive paclitaxel (Taxol®) chemotherapy at home, 6 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Treatment At Clinic and Home</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive paclitaxel (Taxol®) chemotherapy at clinic, 2 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive paclitaxel (Taxol®) chemotherapy at home, 4 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Providing cancer treatment at home, versus in the clinic, may help reduce mental and financial distress and increase treatment compliance, especially for marginalized patients and communities.</li> <li class="seamTextUnorderedListItem">Home health appointments include chemotherapy administration, routine vital sign monitoring, and routine lab tests.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05969860' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/medical-professionals/cancer/news/high-quality-advanced-cancer-care-conducted-at-home/mac-20538184' target='_blank'>Mayo Clinic: Cancer CARE Beyond Walls</a> </li></ul>
26

Chemotherapy Treatment At Home for People with Advanced Breast Cancer

Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic
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Nearest Location:
1454 miles
Altru Cancer Center
Grand Forks, ND

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05969860

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Phase II

27

BNT323 ADC and BNT327 Immunotherapy for Advanced HER2 Low, HER2 Ultra Low, and HER2 Negative Breast Cancer

A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of BNT323, an experimental antibody drug conjugate (ADC), and/or BNT327, an experimental immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 low, HER2 ultralow, and HER2 negative (HER2-) breast cancer. You must not have received treatment with <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®) or sacituzumab govitecan (Trodelvy®) ADCs or irinotecan (Camptosr®) chemotherapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT323, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT327, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT323, by IV</li> <li class="seamTextUnorderedListItem">BNT327, by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT323 is an experimental targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in BNT323 targets HER2 proteins. It delivers a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">BNT327 is an experimental targeted therapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to 2 distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">BNT327 binds to PD-L1 and VEGF.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC1+ or IHC 2+/ISH-.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06827236' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.biontech.com/trials/BNT323-03?utm_source=chatgpt.com' target='_blank'>BioNTech: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='file:///Users/alexandraburd/Downloads/BNT_Factsheet_BNT323DB_1303_RZ_EN.pdf' target='_blank'>BioNTech: BNT323 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/bispecific-antibodies-for-mbc/' target='_blank'>Metastatic Trial Talk: Bispecific Antibodies: An Emerging Class Of MBC Drugs</a> </li></ul>
27

BNT323 ADC and BNT327 Immunotherapy for Advanced HER2 Low, HER2 Ultra Low, and HER2 Negative Breast Cancer

A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer
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Nearest Location:
1481 miles
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, TX

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Visits:
At least 11 visits every 2 weeks

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ClinicalTrials.gov: NCT06827236

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Phase I-II

28

PRE-I-SPY: Targeted Therapy and Immunotherapy for Advanced HER2+ or HER2 Low Breast Cancer

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial (PRE-I-SPY-PI)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of various combinations of targeted therapy and immunotherapy drugs for people with advanced breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who have received no more than 1 line of therapy for advanced disease. View full eligibility criteria

What's involved?


What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evorpacept (ALX148) is an experimental immunotherapy called a CD47 inhibitor. Blocking CD47 may help stimulate the immune system to attack and cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is a type of immunotherapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) uses the HER2-targeted antibody <span class="highlight">trastuzumab</span> to deliver the chemotherapy DM1 directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">Zanidatamab is an experimental targeted therapy called a bispecific antibody that binds to 2 targets on HER2.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to 2 distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/FISH -.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05868226' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.quantumleaphealth.org/for-patients/i-spy-trials/' target='_blank'>Quantum Leap Healthcare Collaborative: Trial Information Page</a> </li></ul>
28

PRE-I-SPY: Targeted Therapy and Immunotherapy for Advanced HER2+ or HER2 Low Breast Cancer

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial (PRE-I-SPY-PI)
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Nearest Location:
1584 miles
University of Minnesota Masonic Cancer Center
Minneapolis, MN

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Visits:
1 visit every 2-3 weeks

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ClinicalTrials.gov: NCT05868226

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Phase I

29

Tucatinib and T-DM1 for HER2-Positive Breast Cancer with Brain Metastasis

A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)

Purpose: To study the anti-cancer activity, safety and side effects of tucatinib and adotrastuzumab emtansine (T-DM1) for controlling brain metastases (breast cancer that has spread to the brain).

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 1 year</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> emtansine (T-DM1; Kadcyla®), by injection, every 3 weeks for 1 year</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps HER2+ cancer cells grow.</li> <li class="seamTextUnorderedListItem">T-DM1 is an antibody-drug conjugate (ADC). It uses the HER2-targeted therapy <span class="highlight">trastuzumab</span> to deliver the chemotherapy DM1 directly to cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05673928' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>breastcancer.org: Tucatinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: T-DM1</a> </li></ul>
29

Tucatinib and T-DM1 for HER2-Positive Breast Cancer with Brain Metastasis

A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)
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Nearest Location:
1643 miles
M D Anderson Cancer Center
Houston, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05673928

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Phase II

30

Valemetostat Targeted Therapy for Advanced HER2 Low, HER2 Ultra Low, or HER2 Null Breast Cancer

Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With <span class="highlight">Trastuzumab</span> Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of valemetostat, an experimental EZH1/2 inhibitor, alone or with <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®) antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 low, HER2 ultra low, or HER2 null breast cancer who have received at least 1 line of chemotherapy for advanced/metastatic disease. You must not have received treatment with any anti-HER2 targeted therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Valemetostat, by mouth</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (Enhertu®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Valemetostat, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Valemetostat is an experimental targeted therapy called a EZH1/2 inhibitor. Blocking EZH1 and EZH2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) uses the HER2 targeted antibody <span class="highlight">trastuzumab</span> to deliver the chemotherapy DM1/deruxtecan directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+/ISH- or IHC 1+/ISH- or undefined.</li> <li class="seamTextUnorderedListItem">HER2 ultra low is defined as IHC 0 with faint ISH staining.</li> <li class="seamTextUnorderedListItem">HER2 null is defined as IHC 0 with no ISH staining.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05633979' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2022-0315.html' target='_blank'>MD Anderson Cancer Center: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.daiichisankyo.com/rd/pipeline/' target='_blank'>Daiichi-Sankyo: Valemetostat Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (Enhertu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/her2-status/' target='_blank'>Metastatic Trial Talk: Why Knowing Your HER2 Status is Important</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/special-topics/enhertu-her2-low/' target='_blank'>Metastatic Trial Talk: FDA Approves Enhertu® for HER2-Low MBC</a> </li></ul>
30

Valemetostat Targeted Therapy for Advanced HER2 Low, HER2 Ultra Low, or HER2 Null Breast Cancer

Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With <span class="highlight">Trastuzumab</span> Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer
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Nearest Location:
1643 miles
M D Anderson Cancer Center
Houston, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05633979

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Phase I

31

Radiation Therapy and HER2-Targeted Therapies Infused Directly into the Brain for HER2+ Breast Cancer with Leptomeningeal Metastases

Phase I/II Study of Radiation Therapy Followed by Intrathecal <span class="highlight">Trastuzumab/Pertuzumab</span> in the Management of HER2+ Breast Leptomeningeal Disease

Purpose: To study the anti-cancer activity and side effects of giving two anti-HER2 targeted therapies directly into the brain after giving radiation therapy to the brain or spine.

Who is this for?: People with metastatic (stage IV) HER2-positive (HER2+) breast cancer with leptomeningeal disease -- breast cancer that has spread to the leptomeninges (see below for the definition). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy to the brain or spine, 5 to 10 times</li> <li class="seamTextUnorderedListItem">Surgery to place a device (Ommaya reservoir) similar to a chemotherapy port under your scalp</li> <li class="seamTextUnorderedListItem">followed by pertuzumab (Perjeta®) and <span class="highlight">trastuzumab</span> (Herceptin®), by Ommaya reservoir, twice a week for one month, then once a week for one month, then every two weeks, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery or other times in the treatment process. </li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) is a HER2 targeted therapy commonly used to treat HER2-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer. </li> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">Ommaya reservoirs are very small plastic devices put under the scalp to give access to cerebrospinal fluid (CSF) -- the fluid or liquid surrounding your brain and spinal cord.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2+ cancer that have spread to the leptomeninges.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04588545' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: What are Leptomeningeal Metastases?</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/cancers/brain-tumor/leptomeningeal-disease/' target='_blank'>Moffitt Cancer Center: Leptomeningeal Disease</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/faq-about-ommaya-reservoirs-and-ommaya-taps' target='_blank'>Memorial Sloan Kettering Cancer Center: Frequently Asked Questions About Ommaya Reservoirs and Ommaya Taps</a> </li></ul>
31

Radiation Therapy and HER2-Targeted Therapies Infused Directly into the Brain for HER2+ Breast Cancer with Leptomeningeal Metastases

Phase I/II Study of Radiation Therapy Followed by Intrathecal <span class="highlight">Trastuzumab/Pertuzumab</span> in the Management of HER2+ Breast Leptomeningeal Disease
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Nearest Location:
1851 miles
Northwestern University
Evanston, IL

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Visits:
Approximately 22 visits over the first 2.5 months; then 1 visit every 2 weeks, ongoing

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ClinicalTrials.gov: NCT04588545

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Phase I-II

32

Vaccine for Metastatic HER2+, HER2 Low, or EGFR+ Breast Cancer

Phase Ib Active Immunotherapy Trial (Expansion) With a Combination of Two Chimeric <span class="highlight">(Trastuzumab-like</span> and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant in Patients With Advanced Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of an experimental HER2 B cell peptide vaccine.

Who is this for?: People with advanced HER2 positive (HER2+), HER2 low, and/or EGFR positive (EGFR+) breast cancer who have received at least 1 line of therapy for advanced disease. You must not have received more than 3 lines of chemotherapy in the last 2 years. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 B cell peptide vaccine, by injection, 3 visits within 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 B cell peptide vaccine booster, by injection, every 6 months (optional)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The HER2 B cell peptide vaccine is an experimental vaccine designed to stimulate your immune system to go after and kill HER2+ cancer cells.</li> <li class="seamTextUnorderedListItem">Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06414733' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancer.iu.edu/patients/clinical-trials/61428' target='_blank'>Indiana University: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/immune-system/vaccines' target='_blank'>Breastcancer.org: Breast Cancer and Vaccines</a> </li></ul>
32

Vaccine for Metastatic HER2+, HER2 Low, or EGFR+ Breast Cancer

Phase Ib Active Immunotherapy Trial (Expansion) With a Combination of Two Chimeric <span class="highlight">(Trastuzumab-like</span> and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant in Patients With Advanced Solid Tumors
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Nearest Location:
1946 miles
Indiana University Melvin & Bren Simon Comprehensive Cancer Center
Indianpolis, IN

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Visits:
At least 3 visits within 3 months

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ClinicalTrials.gov: NCT06414733

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Phase I

33

Sacituzumab Govitecan ADC and <span class="highlight">Trastuzumab</span> Targeted Therapy for Advanced HER2+ Breast Cancer

A Single-arm Phase II Trial of SAcituzumab Govitecan and <span class="highlight">Trastuzumab</span> for HER2+ Metastatic Breast Cancer After progrEssion on ENhertu (SATEEN)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®, T-DXd) antibody drug conjugate (ADC) with <span class="highlight">trastuzumab</span> (Herceptin®) anti-HER2 targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received treatment with <span class="highlight">trastuzumab</span> (Herceptin®), <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®), and paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), or docetaxel (Taxotere®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (Enhertu®, T-DXd), weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV or injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">CT or MRI scans, every 2-3 months</li> <li class="seamTextUnorderedListItem">Heart scan, every 3-4 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Herceptin® Hylecta is a form of <span class="highlight">trastuzumab</span> that is given by injection instead of by IV.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06100874' target='_blank'>ClinicalTrials.gov</a> </li></ul>
33

Sacituzumab Govitecan ADC and <span class="highlight">Trastuzumab</span> Targeted Therapy for Advanced HER2+ Breast Cancer

A Single-arm Phase II Trial of SAcituzumab Govitecan and <span class="highlight">Trastuzumab</span> for HER2+ Metastatic Breast Cancer After progrEssion on ENhertu (SATEEN)
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Nearest Location:
1959 miles
SCRI Oncology Partners
Nashville, TN

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Visits:
1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT06100874

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Phase II

34

Sacituzumab Govitecan ADC After T-DXd ADC for Advanced HR+, HER2 Low Breast Cancer

SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW MetaStatic Breast Cancer

Purpose: To study if sacituzumab govitecan (SG, Trodelvy®) is still effective at the currently approved dose and schedule for people with advanced HR+, HER2 low breast cancer who have already received <span class="highlight">trastuzumab</span> deruxtecan (T-DXd, Enhertu®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 low breast cancer who have received treatment with hormone therapy, CDK4/6 inhibitor, <span class="highlight">trastuzumab</span> deruxtecan (T-DXd, Enhertu®), and 1-4 lines of chemotherapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (SG, Trodelvy®), by IV, weekly, 2 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Although Sacituzumab govitecan (SG, Trodelvy®) is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if it is still effective specifically in people who have already received T-DXd.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (SG, Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (SG, Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+/ISH- or IHC 1+/ISH- or ISH untested.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06263543' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/?_gl=1*msj5sm*_ga*NDI3ODYxOTY5LjE2NzE2MzcwODA.*_ga_Y9F235S3X2*MTcxMDc3NDgwNy40MTEuMS4xNzEwNzc2MTM5LjQ2LjAuMA..' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab Govitecan (SG, Trodelvy®)</a> </li></ul>
34

Sacituzumab Govitecan ADC After T-DXd ADC for Advanced HR+, HER2 Low Breast Cancer

SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW MetaStatic Breast Cancer
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Nearest Location:
2139 miles
Winship Cancer Institute at Emory University
Atlanta, GA

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Visits:
1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT06263543

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Phase II

35

Studying a New Order of Giving Currently Approved Drugs for Women with HR+, HER2- Breast Cancer

A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive Metastatic Breast Cancer

Purpose: To study a new order of giving currently approved drugs to treat metastatic breast cancer.

Who is this for?: Women with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received an aromatase inhibitor or tamoxifen (Nolvadex®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) or <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) or abemaciclib (Verzenio®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are continually developing new drugs to treat metastatic breast cancer (MBC) and understanding how to best use drugs already approved for MBC.</li> <li class="seamTextUnorderedListItem">An important question in treatment planning is the order in which drugs are given, called “drug sequencing”.</li> <li class="seamTextUnorderedListItem">All drugs in this trial are approved for metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), docetaxel (Taxotere®), and capecitabine (Xeloda®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) and <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®) are types of targeted therapy called antibody drug conjugates (ADC).</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) and abemaciclib (Verzenio®) are types of targeted therapy called CDK4/6 inhibitors.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06409390' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/drug-sequencing/?utm_medium=email&utm_source=subscribers&utm_campaign=Mar2024&utm_content=Email032024' target='_blank'>Metastatic Trial Talk: What is “Drug Sequencing”?</a> </li></ul>
35

Studying a New Order of Giving Currently Approved Drugs for Women with HR+, HER2- Breast Cancer

A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive Metastatic Breast Cancer
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Nearest Location:
2395 miles
Moffitt Cancer Center
Tampa, FL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06409390

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Phase II

36

T-Cell Therapy, Dendritic Cell Vaccine & Targeted Therapy for HER2+ Metastatic Breast Cancer

Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab / <span class="highlight">Trastuzumab</span> in Patients With Metastatic HER2-Positive Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of T-cell therapy after dendritic cell vaccines with pepinemab, an experimental targeted therapy, and <span class="highlight">trastuzumab</span> (Herceptin®), a HER2-targeted therapy.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that progressed on <span class="highlight">trastuzumab</span> (Herceptin®). You must not have received more than 3 lines of therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, weekly for 6 weeks</li> <li class="seamTextUnorderedListItem">Pepinemab, by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> followed by (2 weeks after last vaccine): </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">T-cell therapy, by IV, 2 sessions over 2 weeks</li> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, every 3 weeks for at least 2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis to collect your T cells</li> <li class="seamTextUnorderedListItem">May require hospital stay</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-cell therapy is a type of immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your T-cells are removed from your body during a process called leukapheresis, modified with CD4+ that allows them to attack HER2 positive cancer cells, and then infused back into your body.</li> <li class="seamTextUnorderedListItem">Before you receive the T-cells, you will be treated with the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your body to receive the T-cells.</li> <li class="seamTextUnorderedListItem">Dendritic cell vaccines are a type of immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Pepinemab is an experimental targeted therapy called a SEMA4D inhibitor. Blocking SEMA4D may stop or slow cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a HER2-targeted therapy commonly used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">After receiving the modified T-cells, you will continue to receive pepinemab, <span class="highlight">trastuzumab</span> (Herceptin®), and booster doses of the dendritic cell vaccine every 3 weeks.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05378464' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adoptive-cell-therapy' target='_blank'>National Cancer Institute: Adoptive T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/vaccines-to-treat-cancer' target='_blank'>Cancer Research UK: Dendritic Cell Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.vaccinex.com/pipeline/pepinemab-immuno-oncology/' target='_blank'>Vaccinex Drug Information Page: Pepinemab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>
36

T-Cell Therapy, Dendritic Cell Vaccine & Targeted Therapy for HER2+ Metastatic Breast Cancer

Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab / <span class="highlight">Trastuzumab</span> in Patients With Metastatic HER2-Positive Breast Cancer
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Nearest Location:
2395 miles
Moffitt Cancer Center
Tampa, FL

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Visits:
May require hospital stay

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ClinicalTrials.gov: NCT05378464

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Phase I

37

<span class="highlight">Trastuzumab</span> Deruxtecan ADC for People with Advanced HER2 Negative or HER2 Low Breast Cancer

A Phase 3b, Multicenter, Global, Interventional, Open-label Study of <span class="highlight">Trastuzumab</span> Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of <span class="highlight">trastuzumab</span> deruxtecan (T-DXd, Enhertu®) antibody drug conjugate (ADC) for advanced HER2 negative or HER2 low breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with HER2 negative (IHC 0) or HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received 1-2 lines of therapy for advanced disease. You must not have received anti-HER2 targeted therapy for advanced disease or any antibody drug conjugate (ADC). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (T-DXd, Enhertu®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®) is a type of immunotherapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) uses the HER2-targeted antibody <span class="highlight">trastuzumab</span> to deliver the chemotherapy DM1 directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05950945' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.destinyclinicaltrials.com/en#DESTINY-breast' target='_blank'>AstraZeneca: DESTINY Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (Enhertu®)</a> </li></ul>
37

<span class="highlight">Trastuzumab</span> Deruxtecan ADC for People with Advanced HER2 Negative or HER2 Low Breast Cancer

A Phase 3b, Multicenter, Global, Interventional, Open-label Study of <span class="highlight">Trastuzumab</span> Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)
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Nearest Location:
2398 miles
USF College of Medicine
Tampa, FL

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05950945

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Phase III

38

Tucatinib Before Surgery for Metastatic HER2+ Breast Cancer That Has Spread to the Brain

Window of Opportunity Analysis of Pre-Operative Tucatinib for Surgically Resected HER2+ Brain Metastases: Understanding Mechanisms of Resistance

Purpose: To study how the brain absorbs, distributes, and gets rid of tucatinib (Tukysa®) in people who have HER2+ breast cancer that has spread to the brain, and to learn more about how cancer cells develop resistance to treatment.

Who is this for?: Women with metastatic (stage IV) HER2+ breast cancer that has spread to the brain (brain metastases) and who are planning to receive surgery to remove the cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 5 days</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa) is a type of HER2 targeting therapy called a kinase inhibitor. It is able to cross the blood-brain barrier. This means it works against cancer cells that have spread to the brain. Tucatinib is approved for use in people with metastatic, HER2+ breast cancer when it is taken with <span class="highlight">trastuzumab</span> and capecitabine. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05892068' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib</a> </li></ul>
38

Tucatinib Before Surgery for Metastatic HER2+ Breast Cancer That Has Spread to the Brain

Window of Opportunity Analysis of Pre-Operative Tucatinib for Surgically Resected HER2+ Brain Metastases: Understanding Mechanisms of Resistance
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Nearest Location:
2539 miles
Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05892068

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Phase II

39

<span class="highlight">Trastuzumab</span> Deruxtecan Antibody Drug Conjugate for Metastatic HER2 Positive, Low, or Mutated Breast Cancer with Brain Metastases

Window of Opportunity Assessment of [Fam-]Trastuzumab DERuxtecan-nxki (T-DXd) Brain Tumor Penetration and Efficacy (WOnDER-BT)

Purpose: To study the safety, effects, and anti-cancer activity of <span class="highlight">trastuzumab</span> deruxtecan (T-DXd, Enhertu®) antibody-drug conjugate (ADC) for people with brain metastases.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+), HER2 low, or HER2 mutated breast cancer that has spread to the brain (brain metastasis) and are planning to receive brain surgery. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (T-DXd, Enhertu®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC1+ or 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06058988' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (T-DXd, Enhertu®)</a> </li></ul>
39

<span class="highlight">Trastuzumab</span> Deruxtecan Antibody Drug Conjugate for Metastatic HER2 Positive, Low, or Mutated Breast Cancer with Brain Metastases

Window of Opportunity Assessment of [Fam-]Trastuzumab DERuxtecan-nxki (T-DXd) Brain Tumor Penetration and Efficacy (WOnDER-BT)
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Nearest Location:
2567 miles
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, NY

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06058988

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Phase II

40

PHESGO Targeted Therapy After Enhertu ADC for People with Advanced HER2+ Breast Cancer

A Multicenter, Open-Label, Single-Arm, Phase II Trial Exploring the Maintenance of <span class="highlight">Trastuzumab</span> and Pertuzumab Following <span class="highlight">Trastuzumab</span> Deruxtecan as Induction Treatment for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer (DEMETHER)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of PHESGO® anti-HER2 targeted therapy after <span class="highlight">trastuzumab</span> deruxtecan (T-DXd, Enhertu®) antibody drug conjugate.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have not yet received chemotherapy or anti-HER2 targeted therapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (T-DXd, Enhertu®), by IV, every 3 weeks for 4.5 months</li> </ul> <p class="seamTextPara"> followed 4.5 months later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PHESGO®, by injection, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®) is an antibody drug conjugate (ADCs).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">PHESGO® is a combination of two anti-HER2 targeted therapies: pertuzumab (Perjeta®) and <span class="highlight">trastuzumab</span> (Herceptin®). It also includes a protein called hyaluronidase which helps your body absorb the targeted therapies.</li> <li class="seamTextUnorderedListItem">Pertuzumab and <span class="highlight">trastuzumab</span> are typically given by IV. With PHESGO®, you can receive these therapies by injection.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06172127' target='_blank'>ClinicalTrials.gov</a> </li></ul>
40

PHESGO Targeted Therapy After Enhertu ADC for People with Advanced HER2+ Breast Cancer

A Multicenter, Open-Label, Single-Arm, Phase II Trial Exploring the Maintenance of <span class="highlight">Trastuzumab</span> and Pertuzumab Following <span class="highlight">Trastuzumab</span> Deruxtecan as Induction Treatment for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer (DEMETHER)
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Nearest Location:
2584 miles
Northwell Health
New York, NY

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT06172127

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Phase II

41

<span class="highlight">Trastuzumab</span> Deruxtecan Antibody Drug Conjugate for Advanced HER2 Negative Breast Cancer

Open-label Single-arm Phase 2 Trial of <span class="highlight">Trastuzumab</span> Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®, T-DXd) antibody drug conjugate for people with metastatic HER2 negative breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer who have received 1-2 lines of therapy (no anti-HER2 targeted therapies) for advanced disease. Your cancer must have always been considered HER2 negative. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (Enhertu®, T-DXd), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">About half of breast cancers that are considered HER2 negative actually have low expression of HER2 (HER2 low) and may respond to anti-HER2 targeted therapies.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan is effective and increases survival in people with HER2 low breast cancers.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06750484' target='_blank'>ClinicalTrials.gov</a> </li></ul>
41

<span class="highlight">Trastuzumab</span> Deruxtecan Antibody Drug Conjugate for Advanced HER2 Negative Breast Cancer

Open-label Single-arm Phase 2 Trial of <span class="highlight">Trastuzumab</span> Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced Breast Cancer
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Nearest Location:
2614 miles
Yale University
New Haven, CT

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT06750484

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Phase II

42

Scalp Cooling to Prevent Hair Loss During Chemotherapy for People With Metastatic Breast Cancer

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer

Purpose: To study the ability of the Paxman Scalp Cooling System to prevent hair loss during treatment with chemotherapy.

Who is this for?: People with metastatic (stage IV) breast cancer that are planning to receive chemotherapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Chemotherapy with Scalp Cooling</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paxman Scalp Cooling System, every 3 weeks</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), sacituzumab govitecan (Trodelvy®), or <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®), by IV, every 1-3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Chemotherapy without Scalp Cooling</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), sacituzumab govitecan (Trodelvy®), or <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®), by IV, every 1-3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Paxman Scalp Cooling System is FDA-approved for preventing hair loss for people undergoing chemotherapy.</li> <li class="seamTextUnorderedListItem">The Paxman Scalp Cooling System has not been studied to look at its ability to prevent hair loss in patients specifically receiving eribulin (Halaven®), sacituzumab govitecan (Trodelvy®), or <span class="highlight">trastuzumab</span> deruxtecan (Enhertu®).</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is a HER2-targeted antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a Trop-2-targeted 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></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04986579' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://coldcap.com//?lang=us' target='_blank'>Paxman: Paxman Scalp Cooling System</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/managing-hair-loss-scalp-cooling' target='_blank'>Memorial Sloan Kettering Cancer Center: Scalp Cooling</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/halaven' target='_blank'>Breastcancer.org: Eribulin (Halaven®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab govitecan (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab deruxtecan (Enhertu®)</a> </li></ul>
42

Scalp Cooling to Prevent Hair Loss During Chemotherapy for People With Metastatic Breast Cancer

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer
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Nearest Location:
2693 miles
Brigham and Women's Hospital
Boston, MA

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Visits:
1 visit every 1-3 weeks

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ClinicalTrials.gov: NCT04986579

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Phase II

43

Multiple Anti-HER2 Targeted Therapies for de Novo Metastatic HER2+ Breast Cancer

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of multiple anti-HER2 targeted therapies in a row instead of changing treatment after cancer progresses.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who were diagnosed with breast cancer at stage IV (de novo). You must not have received treatment except for less than 1.5 months of <span class="highlight">trastuzumab</span> (Herceptin®), pertuzumab (Perjeta®), and chemotherapy (THP). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), docetaxel (Taxotere®), or nab-paclitaxel (Abraxane®), by IV, every 1-3 weeks for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> deruxtecan (Enhertu®, T-DXd), by IV, every 3 weeks for 4-5 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> emtansine (Kadcyla®, T-DM1), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by IV, every 3 weeks for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 1 year</li> <li class="seamTextUnorderedListItem"><span class="highlight">Trastuzumab</span> (Herceptin®), by IV, every 3 weeks for 1 year</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks for 1 year</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The U.S. Food and Drug Administration (FDA) has approved all the study drugs as a treatment option for metastatic HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">In standard of care treatment, you typically change treatment after your cancer progresses.</li> <li class="seamTextUnorderedListItem">In this study, you will receive a series of treatments in a row without waiting for disease progression.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are anti-HER2 targeted therapies used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), docetaxel (Taxotere®), or nab-paclitaxel (Abraxane®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd) and <span class="highlight">trastuzumab</span> emtansine (Kadcyla®, T-DM1) are antibody drug conjugates (ADCs).</li> <li class="seamTextUnorderedListItem">An ADC is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme that helps cancer cells grow.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06439693' target='_blank'>ClinicalTrials.gov</a> </li></ul>
43

Multiple Anti-HER2 Targeted Therapies for de Novo Metastatic HER2+ Breast Cancer

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study
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Nearest Location:
2693 miles
Dana-Farber Cancer Institute
Boston, MA

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Visits:
1 visit every 1-3 weeks for 1.5 years

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ClinicalTrials.gov: NCT06439693

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Phase II

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