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1

Sequence of Two ADCs for Advanced HER2 Low Breast Cancer

A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab 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">Trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®),</span> 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">Trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®),</span> 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, <span class="highlight">Enhertu®)</span> 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, <span class="highlight">Enhertu®)'s</span> 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 trastuzumab deruxtecan <span class="highlight">(Enhertu®)</span> 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>
1

Sequence of Two ADCs for Advanced HER2 Low Breast Cancer

A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab 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

2

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 Trastuzumab 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 trastuzumab (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 trastuzumab deruxtecan <span class="highlight">(Enhertu®,</span> 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">Trastuzumab (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>
2

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 Trastuzumab 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

3

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 trastuzumab deruxtecan <span class="highlight">(Enhertu®)</span> 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>
3

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

4

Tumor Test to Predict Response to <span class="highlight">Enhertu®</span> 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 trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®).</span>

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) trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®).</span> 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 trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®),</span> 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>
4

Tumor Test to Predict Response to <span class="highlight">Enhertu®</span> 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

5

RLY-2608 PI3Kα Inhibitor Plus Fulvestrant Versus Capivasertib AKT Inhibitor Plus Fulvestrant for Advanced PIK3CA-Mutant HR+, HER2- Breast Cancer

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Tr...(ReDiscover-2)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of RLY-2608 PI3Kα inhibitor plus fulvestrant (Faslodex®) hormone therapy versus capivasertib (Truqap®) AKT inhibitor plus fulvestrant (Faslodex®).

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 with a PIK3CA mutation whose cancer has progressed while receiving 1 or 2 lines of hormone therapy and a CDK4/6 inhibitor. You must not have received certain treatments that are listed below. 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">RLY-2608, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib (Truqap®), by mouth, daily, 4 days on 3 days off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Capivasertib (Truqap®) is used to treat HR+, HER2- advanced breast cancer with a mutation in PIK3CA, AKT1, or PTEN.</li> <li class="seamTextUnorderedListItem">RLY-2608 is an experimental treatment being tested to treat HR+, HER2- advanced breast cancer with a mutation in PIK3CA.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li> <li class="seamTextUnorderedListItem">To be eligible for this trial, you must not have received any of the following treatments: alpelisib (Piqray®), capivasertib (Truqap®), pembrolizumab (Keytruda®), dostarlimab-gxly (Jemperli®), fam-trastuzumab deruxtecan-nxki <span class="highlight">(Enhertu®),</span> sacituzumab govitecan-hziy (Trodelvy®), or datopotamab deruxtecan (Dato-DXd; Datroway®).</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/NCT06982521' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://relaytx.com/pipeline/#hero-scroll' target='_blank'>Relay Therapeutics: RLY-2608</a> </li></ul>
5

RLY-2608 PI3Kα Inhibitor Plus Fulvestrant Versus Capivasertib AKT Inhibitor Plus Fulvestrant for Advanced PIK3CA-Mutant HR+, HER2- Breast Cancer

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Tr...(ReDiscover-2)
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Nearest Location:
3 miles
University of California San Francisco
San Francisco, CA

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Visits:
Monthly

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ClinicalTrials.gov: NCT06982521

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Phase III

6

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 trastuzumab deruxtecan <span class="highlight">(Enhertu®).</span> 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>
6

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

7

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 Trastuzumab Deruxtecan (T-DXd) or in Combination With Intravenous Trastuzumab 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 trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®)</span> or trastuzumab 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">Trastuzumab 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">Trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®),</span> 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, <span class="highlight">Enhertu®)</span> and trastuzumab 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, <span class="highlight">Enhertu®)'s</span> 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>
7

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 Trastuzumab Deruxtecan (T-DXd) or in Combination With Intravenous Trastuzumab 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

8

Patritumab Deruxtecan ADC Compared to Chemotherapy or Trastuzumab 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 trastuzumab deruxtecan (T-DXd; <span class="highlight">Enhertu®)</span> 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 trastuzumab deruxtecan (T-DXd; <span class="highlight">Enhertu®),</span> 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>
8

Patritumab Deruxtecan ADC Compared to Chemotherapy or Trastuzumab 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

9

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 trastuzumab deruxtecan <span class="highlight">(Enhertu®)</span> 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>
9

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

10

Bulumtatug Fuvedotin Antibody-Drug Conjugate for Advanced Triple-Negative Breast Cancer

An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of bulumtatug fuvedotin antibody-drug conjugate.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received no more than 3 lines of therapy. Past treatment must have included a taxane and certain antibody-drug conjugates. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bulumtatug fuvedotin, by IV, weekly, 2 weeks on 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bulumtatug fuvedotin is an antibody-drug conjugate that targets a protein called nectin-4 that is present on cancer cells.</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">Taxanes are paclitaxel (Taxol®) and docetaxel (Taxotere®).</li> <li class="seamTextUnorderedListItem">You must have received one of these antibody-drug conjugates: fam-trastuzumab deruxtecan-nxki <span class="highlight">(Enhertu®),</span> sacituzumab govitecan-hziy (Trodelvy®), and datopotamab deruxtecan (Dato-DXd; Datroway®).</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/NCT06908928' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mabwell.com/en/rd.html' target='_blank'>Mabwell: Bulumtatug Fuvedotin</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>
10

Bulumtatug Fuvedotin Antibody-Drug Conjugate for Advanced Triple-Negative Breast Cancer

An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates
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Nearest Location:
353 miles
City of Hope
Duarte, CA

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Visits:
2 visits every 3 weeks for 2 years

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ClinicalTrials.gov: NCT06908928

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Phase I

11

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 trastuzumab deruxtecan <span class="highlight">(Enhertu®),</span> an antibody drug conjugate (ADC).

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

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">64Cu-DOTA-trastuzumab, by IV, 1 time</li> <li class="seamTextUnorderedListItem">PET/MRI scan, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI scan, every 1.5 months for 6 months, then every 2 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan <span class="highlight">(Enhertu®),</span> 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 <span class="highlight">(Enhertu®)</span> 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 <span class="highlight">(Enhertu®)'s</span> 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>
11

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

12

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 trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®)</span> 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">Trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®),</span> 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, <span class="highlight">Enhertu®)</span> 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, <span class="highlight">Enhertu®)'s</span> 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>
12

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

13

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 trastuzumab deruxtecan <span class="highlight">(Enhertu®)</span> 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>
13

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

14

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 trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®)</span> 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>
14

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

15

Exercise for Fatigue for People with Advanced Breast Cancer Receiving Trastuzumab Deruxtecan

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on <span class="highlight">Enhertu:</span> 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 trastuzumab deruxtecan <span class="highlight">(Enhertu®)</span> 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>
15

Exercise for Fatigue for People with Advanced Breast Cancer Receiving Trastuzumab Deruxtecan

ENERGIZE: Engagement With a Nurturing Exercise Routine for Greater Improvement in Zest and Energy on <span class="highlight">Enhertu:</span> 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

16

Dato-DXd for Advanced HR+, HER2- Breast Cancer

A Phase IIIb, Open-label, Multinational Study Assessing the Efficacy and Safety of Dato-DXd Treatment in Patients With HRpositive, HER2 IHC 0, Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy (TROPION-Breast06)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of datopotamab deruxtecan (Dato-DXd; Datroway®) antibody-drug conjugate.

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 that has become resistant to hormone therapy. You must not have received chemotherapy, fam-trastuzumab deruxtecan-nxki <span class="highlight">(Enhertu®),</span> sacituzumab govitecan-hziy (Trodelvy®), or datopotamab deruxtecan (Dato-DXd; Datroway®) for your advanced cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd; Datroway®), by IV, every 3 weeks, up to 5 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">In this study, HER2- is defined as IHC 0 (no staining or incomplete and faint/barely perceptible membrane staining in ≤10% of tumor cells).</li> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd; Datroway®) is an antibody-drug conjugate (ADC). An ADC is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill 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/NCT07205822' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://datroway.com/?gclsrc=aw.ds&gad_source=1&gad_campaignid=22411693368&gbraid=0AAAAA-nL_-fHlfedCQ0wuAVgecBaDMC80&gclid=CjwKCAiA0eTJBhBaEiwA-Pa-hbSesNEE7n09CdOw1ZrQBMl6NMyWMeF6MMPq4fD30xu3Pn1CBF7EIRoCWUsQAvD_BwE' target='_blank'>Daiichi Sankyo: Datopotamab Deruxtecan (Dato-DXd; Datroway®)</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>
16

Dato-DXd for Advanced HR+, HER2- Breast Cancer

A Phase IIIb, Open-label, Multinational Study Assessing the Efficacy and Safety of Dato-DXd Treatment in Patients With HRpositive, HER2 IHC 0, Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy (TROPION-Breast06)
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Nearest Location:
649 miles
Research Site
Puyallup, WA

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Visits:
Every 3 weeks up to 5 years

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ClinicalTrials.gov: NCT07205822

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Phase III

17

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 Trastuzumab 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">Trastuzumab deruxtecan <span class="highlight">(Enhertu®,</span> 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 <span class="highlight">(Enhertu®,</span> 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, <span class="highlight">Enhertu®)'s</span> 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>
17

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 Trastuzumab 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

18

Changing the Dose of Capecitabine According to Scans to Control Metastatic ER+, HER2- Breast Cancer

Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of changing the dose of capecitabine (Xeloda®) chemotherapy according to the results of scans.

Who is this for?: People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer. You must not have received chemotherapy or fam-trastuzumab deruxtecan-nxki <span class="highlight">(Enhertu®),</span> sacituzumab govitecan-hziy (Trodelvy®), or datopotamab deruxtecan (Dato-DXd; Datroway®) for your metastatic breast cancer. You must not have uncontrolled brain metastases. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth</li> <li class="seamTextUnorderedListItem">Bone scan</li> <li class="seamTextUnorderedListItem">CT scan</li> <li class="seamTextUnorderedListItem">MRI scan</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Changing the dose of capecitabine (Xeloda®) according to how the tumor is growing on a scan may allow someone to live longer. This is called <q>adaptive therapy</q>. The goal of adaptive therapy is not to get rid of the entire tumor but to control its growth in a way that helps the patient live longer with a better quality of life.</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/NCT06525766' target='_blank'>ClinicalTrials.gov</a> </li></ul>
18

Changing the Dose of Capecitabine According to Scans to Control Metastatic ER+, HER2- Breast Cancer

Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer
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Nearest Location:
660 miles
Mayo Clinic in Arizona
Scottsdale, AZ

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Visits:
Number of visits unavailable, up to 5 years

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ClinicalTrials.gov: NCT06525766

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Phase II

19

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 trastuzumab deruxtecan <span class="highlight">(Enhertu®,</span> 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">Trastuzumab (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">Trastuzumab (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>
19

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

20

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 trastuzumab deruxtecan <span class="highlight">(Enhertu®)</span> 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>
20

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

21

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 <span class="highlight">(Enhertu®)</span> 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 <span class="highlight">(Enhertu®)</span> uses the HER2-targeted antibody trastuzumab 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>
21

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

22

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

Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of valemetostat, an experimental EZH1/2 inhibitor, alone or with trastuzumab deruxtecan <span class="highlight">(Enhertu®)</span> 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">Trastuzumab deruxtecan <span class="highlight">(Enhertu®),</span> 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 <span class="highlight">(Enhertu®)</span> 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 <span class="highlight">(Enhertu®)</span> uses the HER2 targeted antibody trastuzumab to deliver the chemotherapy DM1/deruxtecan directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+/ISH- or IHC 1+/ISH- or undefined.</li> <li class="seamTextUnorderedListItem">HER2 ultra low is defined as IHC 0 with faint ISH staining.</li> <li class="seamTextUnorderedListItem">HER2 null is defined as IHC 0 with no ISH staining.</li></ul>

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>
22

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

Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer
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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

23

Sacituzumab Govitecan ADC and Trastuzumab Targeted Therapy for Advanced HER2+ Breast Cancer

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received treatment with trastuzumab (Herceptin®), trastuzumab deruxtecan <span class="highlight">(Enhertu®),</span> 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">Trastuzumab deruxtecan <span class="highlight">(Enhertu®,</span> T-DXd), weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV or injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">CT or MRI scans, every 2-3 months</li> <li class="seamTextUnorderedListItem">Heart scan, every 3-4 months</li></ul>

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 trastuzumab that is given by injection instead of by IV.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>

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>
23

Sacituzumab Govitecan ADC and Trastuzumab Targeted Therapy for Advanced HER2+ Breast Cancer

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

24

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 trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®).</span>

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, trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®),</span> 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>
24

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

25

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 trastuzumab deruxtecan <span class="highlight">(Enhertu®)</span></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 trastuzumab deruxtecan <span class="highlight">(Enhertu®)</span> 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>
25

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

26

Trastuzumab Deruxtecan ADC for People with Advanced HER2 Negative or HER2 Low Breast Cancer

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

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®)</span> 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">Trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®),</span> by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®)</span> 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 <span class="highlight">(Enhertu®)</span> uses the HER2-targeted antibody trastuzumab to deliver the chemotherapy DM1 directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li></ul>

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>
26

Trastuzumab Deruxtecan ADC for People with Advanced HER2 Negative or HER2 Low Breast Cancer

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

27

Trastuzumab Deruxtecan Antibody Drug Conjugate for Metastatic HER2 Positive, Low, or Mutated Breast Cancer with Brain Metastases

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

Purpose: To study the safety, effects, and anti-cancer activity of trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®)</span> 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">Trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®),</span> by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan <span class="highlight">(Enhertu®)</span> 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 <span class="highlight">(Enhertu®)'s</span> 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>
27

Trastuzumab Deruxtecan Antibody Drug Conjugate for Metastatic HER2 Positive, Low, or Mutated Breast Cancer with Brain Metastases

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

28

PHESGO Targeted Therapy After <span class="highlight">Enhertu</span> ADC for People with Advanced HER2+ Breast Cancer

A Multicenter, Open-Label, Single-Arm, Phase II Trial Exploring the Maintenance of Trastuzumab and Pertuzumab Following Trastuzumab 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 trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®)</span> 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">Trastuzumab deruxtecan (T-DXd, <span class="highlight">Enhertu®),</span> 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, <span class="highlight">Enhertu®)</span> 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, <span class="highlight">Enhertu®)'s</span> 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 trastuzumab (Herceptin®). It also includes a protein called hyaluronidase which helps your body absorb the targeted therapies.</li> <li class="seamTextUnorderedListItem">Pertuzumab and trastuzumab are typically given by IV. With PHESGO®, you can receive these therapies by injection.</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>
28

PHESGO Targeted Therapy After <span class="highlight">Enhertu</span> ADC for People with Advanced HER2+ Breast Cancer

A Multicenter, Open-Label, Single-Arm, Phase II Trial Exploring the Maintenance of Trastuzumab and Pertuzumab Following Trastuzumab 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

29

Trastuzumab Deruxtecan Antibody Drug Conjugate for Advanced HER2 Negative Breast Cancer

Open-label Single-arm Phase 2 Trial of Trastuzumab 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 trastuzumab deruxtecan <span class="highlight">(Enhertu®,</span> 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">Trastuzumab deruxtecan <span class="highlight">(Enhertu®,</span> 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 <span class="highlight">(Enhertu®)</span> 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 <span class="highlight">(Enhertu®)'s</span> 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>
29

Trastuzumab Deruxtecan Antibody Drug Conjugate for Advanced HER2 Negative Breast Cancer

Open-label Single-arm Phase 2 Trial of Trastuzumab 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

30

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 trastuzumab deruxtecan <span class="highlight">(Enhertu®),</span> 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 trastuzumab deruxtecan <span class="highlight">(Enhertu®),</span> 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 trastuzumab deruxtecan <span class="highlight">(Enhertu®).</li></span> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan <span class="highlight">(Enhertu®)</span> 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>
30

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

31

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 trastuzumab (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">Trastuzumab (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">Trastuzumab deruxtecan <span class="highlight">(Enhertu®,</span> 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">Trastuzumab 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">Trastuzumab (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 <span class="highlight">(Enhertu®,</span> T-DXd) and trastuzumab 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>
31

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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