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1

Tersolisib PI3Ka Inhibitor For HR+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low</span> Advanced Breast Cancer with a PIK3CA Mutation

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of Tersolisib (LY4064809), an experimental PI3Ka inhibitor, with standard of care CDK4/6 inhibitor and hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), <span class="highlight">HER2</span> negative (HER2-) or <span class="highlight">HER2</span> <span class="highlight">low</span> breast cancer with a PIK3CA mutation. You may have received 0-2 prior treatments for advanced or metastatic breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 1: For people who have received prior treatment:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tersolisib (LY4064809), by mouth, once or twice a day</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor determined by your physician, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy determined by your physician, by mouth or injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 2: For people who have not yet received treatment, you will be randomly assigned to 1 of 2 groups:</i> </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tersolisib (LY4064809), by mouth, once or twice a day</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor determined by your physician, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy determined by your physician, by mouth or injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, once or twice a day</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor determined by your physician, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy determined by your physician, by mouth or injection</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tersolisib (LY4064809) is an experimental type of targeted therapy called a PI3K inhibitor. </li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, allowing cancer cells to grow. Tersolisib may slow or stop cancer cells from growing by blocking this pathway.</li> <li class="seamTextUnorderedListItem">Standard of care treatment for hormone receptor positive (ER+ and/or PR+), <span class="highlight">HER2</span> negative (HER2-) breast cancer is treatment with hormone therapy along with a CDK inhibitor.</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/NCT07174336' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/mbc-biomarkers-part-1/' target='_blank'>Metastatic Trial Talk: Biomarkers to Guide MBC Treatment Decisions: PIK3CA, BRCA1/BRCA2, and PD-L1/PD-1</a> </li></ul>
1

Tersolisib PI3Ka Inhibitor For HR+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low</span> Advanced Breast Cancer with a PIK3CA Mutation

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)
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Nearest Location from 94107:
15 miles
Marin Cancer Care
Greenbrae, CA

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Visits:
Every 2 weeks for 2 months; then monthly visits thereafter

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ClinicalTrials.gov: NCT07174336

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Phase III

2

Saruparib PARP1 Inhibitor with Camizestrant Hormone Therapy for Advanced HR+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low</span> Breast Cancer with BRCA1, BRCA2, or PALB2 Mutations

EvoPAR-BR01: A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Br...

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of saruparib, an experimental PARP1 inhibitor, with camizestrant, an experimental hormone therapy, to standard of care CDK4/6 inhibitor with hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), <span class="highlight">HER2</span> negative (HER2-) or <span class="highlight">HER2</span> <span class="highlight">low</span> (IHC 1+ or IHC 2+/ISH-) breast cancer with BRCA1, BRCA2, or PALB2 mutations. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Saruparib (AZD5305), by mouth</li> <li class="seamTextUnorderedListItem">Camizestrant, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">Aromatase inhibitor, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">Camizestrant, by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Saruparib (AZD5305) is an experimental targeted therapy called a PARP1 inhibitor. PARP inhibitors stop the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP).</li> <li class="seamTextUnorderedListItem">Camizestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), and anastrozole (Arimidex®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and palbociclib (Ibrance®) are a type of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+ 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/NCT06380751' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazenecaclinicaltrials.com/study/D9722C00001/' target='_blank'>AstraZeneca: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/next-generation-parp-inhibitor-demonstrates-clinical-benefit-in-patients-with-homologous-recombination-repair-deficient-breast-cancer/' target='_blank'>AACR: Saruparib for Homologous Recombination Repair Deficient Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>AACR: Camizestrant for Hormone Receptor Positive, HER2 Negative Breast Cancer</a> </li></ul>
2

Saruparib PARP1 Inhibitor with Camizestrant Hormone Therapy for Advanced HR+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low</span> Breast Cancer with BRCA1, BRCA2, or PALB2 Mutations

EvoPAR-BR01: A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Br...
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Nearest Location from 94107:
336 miles
Research Site
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06380751

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Phase III

3

Radioactive Drug with Chemotherapy for Metastatic ER+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low,</span> GRPR+ Breast Cancer

A Phase I/II, Open-label, Multi-center Trial of [177Lu]Lu-NeoB in Combination With Capecitabine in Adult Patients With Gastrin Releasing Peptide Receptor Positive, Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inh...(NeoB-Cap1)

Purpose: To study the safety, best dose, and effects (good and bad) of 177Lu-Lu-NeoB, an experimental radioactive drug, with capecitabine (Cytoxan®) chemotherapy.

Who is this for?: People with metastatic (stage IV) estrogen receptor positive (ER+), <span class="highlight">HER2</span> negative (HER2-) or <span class="highlight">HER2</span> <span class="highlight">low</span> breast cancer that is GRPR positive (GRPR+) who have received no more than 3 lines of hormone therapy (including a CDK4/6 inhibitor) for metastatic disease. You must not have received more than 1 line of chemotherapy or antibody drug conjugate (ADC) for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">177Lu-Lu-NeoB, by IV, every 3-6 weeks</li> <li class="seamTextUnorderedListItem">Capecitabine (Cytoxan®), by mouth, daily, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">PET/CT or PET/MRI scan with 68Ga-Ga-NeoB, by IV, 1-2 times</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are developing a new class of drugs called radiopharmaceuticals, which deliver radiation therapy directly and specifically to cancer cells.</li> <li class="seamTextUnorderedListItem">177Lu-Lu-NeoB is an experimental radiation therapy drug called a radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">177Lu-Lu-NeoB targets tumors that are positive for GRPR (gastrin releasing peptide receptor).</li> <li class="seamTextUnorderedListItem">Capecitabine (Cytoxan®) is an FDA-approved chemotherapy drug.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">The experimental tracer in this study is 68Ga-Ga-NeoB.</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/NCT06247995' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/clinicaltrials/study/NCT06247995' target='_blank'>Novartis: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.moffitt.org/diagnostic-services/radiology-diagnostic-imaging-and-interventional-radiology/services-and-locations/radiopharmaceuticals/#:~:text=Radiopharmaceuticals%20are%20a%20unique%20class,linker%20that%20joins%20the%20two.' target='_blank'>Moffitt Cancer Center: Radiopharmaceuticals</a> </li></ul>
3

Radioactive Drug with Chemotherapy for Metastatic ER+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low,</span> GRPR+ Breast Cancer

A Phase I/II, Open-label, Multi-center Trial of [177Lu]Lu-NeoB in Combination With Capecitabine in Adult Patients With Gastrin Releasing Peptide Receptor Positive, Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inh...(NeoB-Cap1)
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Nearest Location from 94107:
336 miles
UCLA Medical Center
Los Angeles, CA

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Visits:
1 visit every 3 weeks for 9 months, then every 1.5 months

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ClinicalTrials.gov: NCT06247995

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Phase I-II

4

177Lu-Lu-NeoB Radioactive Drug with Ribociclib and Fulvestrant for Advanced ER+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low,</span> GRPR+ Breast Cancer

A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative and Gastrin Releasing Peptide Receptor Positive Advanced Breast Cancer Experiencing Early Relapse From (Neo)Adjuvant Endocr...

Purpose: To study the safety, best dose, and effects (good and bad) of 177Lu-Lu-NeoB, an experimental radioactive drug, with ribociclib (Kisqali®) targeted therapy and fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), <span class="highlight">HER2</span> negative (HER2-) or <span class="highlight">HER2</span> <span class="highlight">low,</span> gastrin releasing peptide receptor (GRPR) positive (GRPR+) breast cancer who have received no more than 1 line of 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">177Lu-Lu-NeoB, by IV, monthly</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> <li class="seamTextUnorderedListItem">PET scans with 68Ga-Ga-NeoB, by IV, 2-3 times</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are developing a new class of drugs called radiopharmaceuticals, which deliver radiation therapy directly and specifically to cancer cells.</li> <li class="seamTextUnorderedListItem">177Lu-Lu-NeoB is an experimental radiation therapy drug called a radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">The experimental tracer in this study is 68Ga-Ga-NeoB.</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">Premenopausal and perimenopausal women and men will also be given a drug every month that will put women in temporary menopause.</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/NCT05870579' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/clinicaltrials/study/NCT05870579' target='_blank'>Novartis: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.moffitt.org/diagnostic-services/radiology-diagnostic-imaging-and-interventional-radiology/services-and-locations/radiopharmaceuticals/#:~:text=Radiopharmaceuticals%20are%20a%20unique%20class,linker%20that%20joins%20the%20two.' target='_blank'>Moffitt Cancer Center: Radiopharmaceuticals</a> </li></ul>
4

177Lu-Lu-NeoB Radioactive Drug with Ribociclib and Fulvestrant for Advanced ER+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low,</span> GRPR+ Breast Cancer

A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative and Gastrin Releasing Peptide Receptor Positive Advanced Breast Cancer Experiencing Early Relapse From (Neo)Adjuvant Endocr...
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Nearest Location from 94107:
336 miles
UCLA Jonsson Comp Cancer Center
Los Angeles, CA

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Visits:
5 visits in 1 month, then 1-2 visits every month

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ClinicalTrials.gov: NCT05870579

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Phase I

5

Izalontamab Brengitecan Versus Chemotherapy for Advanced Triple Negative or ER <span class="highlight">Low</span> Breast Cancer

A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable,or Metastatic Triple-negative Breast Cancer (TNBC)or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of izalontamab brengitecan, a bi-specific antibody-drug conjugate (ADC), compared to standard chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or estrogen receptor <span class="highlight">low</span> (ER <span class="highlight">low)</span> breast cancer who have not yet received treatment for their metastatic disease. You must be ineligible for anti-PD-1, anti-PD-L1, and hormone therapy. 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">Izalontamab brengitecan</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy</li></ul>

What's being studied?


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/NCT06926868' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bms.com/researchers-and-partners/in-the-pipeline.html' target='_blank'>Bristol Myers Squibb: Izalontamab brengitecan</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>
5

Izalontamab Brengitecan Versus Chemotherapy for Advanced Triple Negative or ER <span class="highlight">Low</span> Breast Cancer

A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable,or Metastatic Triple-negative Breast Cancer (TNBC)or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment
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Nearest Location from 94107:
340 miles
Valkyrie Clinical Trials
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06926868

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Phase II-III

6

BNT323 ADC and BNT327 Immunotherapy for Advanced <span class="highlight">HER2</span> <span class="highlight">Low,</span> <span class="highlight">HER2</span> Ultra <span class="highlight">Low,</span> and <span class="highlight">HER2</span> 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) <span class="highlight">HER2</span> <span class="highlight">low,</span> <span class="highlight">HER2</span> ultralow, and <span class="highlight">HER2</span> negative (HER2-) breast cancer. You must not have received treatment with trastuzumab deruxtecan (Enhertu®) or sacituzumab govitecan (Trodelvy®) ADCs or irinotecan (Camptosr®) chemotherapy. View full eligibility criteria

What's involved?

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

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT323 is an experimental targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in BNT323 targets <span class="highlight">HER2</span> 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, <span class="highlight">HER2</span> <span class="highlight">low</span> 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>
6

BNT323 ADC and BNT327 Immunotherapy for Advanced <span class="highlight">HER2</span> <span class="highlight">Low,</span> <span class="highlight">HER2</span> Ultra <span class="highlight">Low,</span> and <span class="highlight">HER2</span> 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 from 94107:
341 miles
Beverly Hills Cancer Center
Beverly Hills, CA

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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

7

SMP-3124LP Targeted Therapy for Advanced Triple Negative Breast Cancer

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults with Advanced Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of SMP-3124LP, an experimental CHK1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER <span class="highlight">low,</span> PR- or PR <span class="highlight">low,</span> HER2- or <span class="highlight">HER2</span> <span class="highlight">low)</span> breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SMP-3124LP, by IV, every 2-3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SMP-3124LP is an experimental targeted therapy called a CHK1 inhibitor. Blocking CHK1 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> 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/NCT06526819' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sumitomo-pharma.com/rd/pipeline_new-medicine/pipeline_profile.html' target='_blank'>Sumitomo Pharma America: SMP-3124 Drug Information Page</a> </li></ul>
7

SMP-3124LP Targeted Therapy for Advanced Triple Negative Breast Cancer

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults with Advanced Solid Tumors
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Nearest Location from 94107:
341 miles
Cedars Sinai Medical Center
Los Angeles, CA

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Visits:
1 visit every 2-3 weeks

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ClinicalTrials.gov: NCT06526819

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Phase I-II

8

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

A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXD) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) <span class="highlight">HER2</span> <span class="highlight">low</span> or <span class="highlight">HER2</span> negative (HER2-) breast cancer who have received at least 1 line of 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">Ifinatamab deruxtecan (I-DXd), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ifinatamab deruxtecan (I-DXd) 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">Ifinatamab deruxtecan (I-DXd)'s antibody targets B7-H3, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 2+/ISH- or IHC 1+.</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/NCT06330064' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/news/january-2024/antibody-drug-conjugate-ifinatamab-deruxtecan-shows-robust-activity-in-refractory-small-cell-lung-cancer/' target='_blank'>ASCO: Antibody-Drug Conjugate Ifinatamab Deruxtecan for Small Cell Lung Cancer</a> </li></ul>
8

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

A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXD) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
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Nearest Location from 94107:
346 miles
Los Angeles Cancer Network
Los Angeles, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT06330064

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Phase II

9

ARTS-021 CDK2 Inhibitor for Advanced HR+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low</span> Breast Cancer

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, MTD/RP2D, and Antitumor Activity of ARTS-021 as a Single Agent and in Combination Therapy in Patients With Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARTS-021, an experimental CDK2 inhibitor, alone or with other anti-cancer drugs.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), <span class="highlight">HER2</span> negative (HER2-) or <span class="highlight">HER2</span> <span class="highlight">low</span> breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease. 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">ARTS-021, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) or letrozole (Femara®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy 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/NCT05867251' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://avenzotx.com/pipeline-and-science/' target='_blank'>Avenzo Therapeutics: ARTS-021 Drug and Trial Information Page</a> </li></ul>
9

ARTS-021 CDK2 Inhibitor for Advanced HR+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low</span> Breast Cancer

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, MTD/RP2D, and Antitumor Activity of ARTS-021 as a Single Agent and in Combination Therapy in Patients With Solid Tumors
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Nearest Location from 94107:
538 miles
Providence Cancer Institute
Portland, OR

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05867251

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Phase I-II

10

Increasing Dose of CDK4/6 Inhibitors with Hormone Therapy to Manage Side Effects for People with Metastatic HR+, HER2- Breast Cancer

Comparing Oral Drug Dosing Strategies in Older Patients with Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: the CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

Purpose: To study increasing the dose of CDK4/6 inhibitors to help people manage side effects and continue taking CDK4/6 inhibitors as prescribed.

Who is this for?: People at least 65 years old with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), <span class="highlight">HER2</span> negative (HER2-) breast cancer who are planning to receive a CDK4/6 inhibitor with hormone therapy. 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: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Regular dose of palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily for 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Increasing <span class="highlight">low</span> dose of palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily for 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) and ribociclib (Kisqali®) are a type of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are in group 1, you will continue the normal dose (unless you need to decrease the dose due to challenging side effects).</li> <li class="seamTextUnorderedListItem">If you are in group 2, you will increase your dose every month (unless you have challenging side effects) up to the normal dose.</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/NCT06377852' target='_blank'>ClinicalTrials.gov</a> </li></ul>
10

Increasing Dose of CDK4/6 Inhibitors with Hormone Therapy to Manage Side Effects for People with Metastatic HR+, HER2- Breast Cancer

Comparing Oral Drug Dosing Strategies in Older Patients with Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: the CDK4/6 Inhibitor Dosing Knowledge (CDK) Study
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Nearest Location from 94107:
600 miles
Ironwood Cancer & Research Centers
Goodyear, AZ

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06377852

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Phase III

11

Personalized Vaccine with Immunotherapy for Metastatic HR+, HER2- Breast Cancer

PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer and PD1/PD-L1 Inhibitor-Refractory Melanoma

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of an experimental vaccine with immunotherapy.

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), <span class="highlight">HER2</span> negative (HER2-) or <span class="highlight">HER2</span> <span class="highlight">low</span> breast cancer who have received at least 1 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">Poly ICLC, by injection, weekly for 2 weeks</li> </ul> <p class="seamTextPara"> followed 2 weeks later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccine, by injection, monthly for 6 months</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2-4 weeks for 6 months</li> <li class="seamTextUnorderedListItem">Poly ICLC, by injection, weekly, 3 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> followed 6 months later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2-4 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccines are an experimental type of immunotherapy. The vaccine is designed to target certain proteins (neoantigens) on tumor cells.</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) 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">Poly ICLC is an immunotherapy that stimulates your immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+.</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/NCT05098210' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/breast-cancer-vaccine-explainer/' target='_blank'>Breast Cancer Research Foundation: Breast Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Nivolumab (Opdivo®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/poly-iclc' target='_blank'>National Cancer Institute: Poly ICLC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
11

Personalized Vaccine with Immunotherapy for Metastatic HR+, HER2- Breast Cancer

PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer and PD1/PD-L1 Inhibitor-Refractory Melanoma
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Nearest Location from 94107:
682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA

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Visits:
1 visit every week for 6 months, then 1 visit every 2-4 weeks

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ClinicalTrials.gov: NCT05098210

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Phase I

12

PET/CT Scan to Predict Response to Abemaciclib for Advanced ER+, HER2- Breast Cancer

A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

Purpose: To study how well functional imaging PET/CT scans with FFNP can predict your cancer's response to abemaciclib (Verzenio®) CDK4/6 inhibitor with standard of care hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+ or ER <span class="highlight">low),</span> <span class="highlight">HER2</span> negative (HER2-) or <span class="highlight">HER2</span> <span class="highlight">low</span> breast cancer who are planning to receive abemaciclib (Verzenio®). You must have received no more than 1 line of chemotherapy for advanced disease. You must not have liver only metastases. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/CT scan with FFNP, by IV, 3 times in 1 month, then every 3 months</li> <li class="seamTextUnorderedListItem">Estradiol, by mouth, 1 day</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">FFNP PET/CT imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that <q>light up</q> with FFNP than a PET scan alone can provide.</li> <li class="seamTextUnorderedListItem">Estradiol is type of hormone therapy for advanced ER+ breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+ or 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/NCT06179303' target='_blank'>ClinicalTrials.gov</a> </li></ul>
12

PET/CT Scan to Predict Response to Abemaciclib for Advanced ER+, HER2- Breast Cancer

A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
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Nearest Location from 94107:
682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA

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Visits:
3 visits in 1 month, then 1 visit every 3 months

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ClinicalTrials.gov: NCT06179303

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Phase II

13

STEMVAC Experimental Vaccine Plus Hormone Therapy or Capecitabine for Metastatic HR+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low</span> Breast Cancer

A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of an experimental vaccine called STEMVAC in combination with standard hormone therapy or capecitabine (Xeloda®).

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), <span class="highlight">HER2</span> negative (HER2-) or <span class="highlight">HER2</span> <span class="highlight">low</span> breast cancer. You must be receiving hormone therapy and a CDK4/6 inhibitor, or have become resistant to hormone therapy and have received at least one cycle of capecitabine (Xeloda®). 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: Hormone Therapy Sensitive</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">STEMVAC, by injection, 5 times within 9 months, then every 6 months</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Hormone Therapy Resistant</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth</li> <li class="seamTextUnorderedListItem">STEMVAC, by injection, 5 times within 9 months, then every 6 months</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times</li> <li class="seamTextUnorderedListItem">FES PET scan</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The STEMVAC vaccine targets proteins expressed on breast cancer stem cells and may boost the ability of the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Hormone therapy blocks the effects of estrogen to block the growth of cancer cells.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow. </li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07112053' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/vaccines-mbc/' target='_blank'>Metastatic Trial Talk: Vaccines for MBC</a> </li></ul>
13

STEMVAC Experimental Vaccine Plus Hormone Therapy or Capecitabine for Metastatic HR+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low</span> Breast Cancer

A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive Metastatic Breast Cancer
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Nearest Location from 94107:
682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA

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Visits:
Number of visits unavailable, up to 3 years

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ClinicalTrials.gov: NCT07112053

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Phase II

14

STEMVAC Vaccine in Combination With Chemo for Metastatic Triple-Negative Breast Cancer that is PD-L1 Negative

A Phase II Trial of the Immunogenicity of a DNA Plasmid-Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of a vaccine called STEMVAC when it is given with standard chemotherapy.

Who is this for?: People with metastatic (stage IV) triple negative (ER- or ER <span class="highlight">low,</span> PR- or PR <span class="highlight">low,</span> HER2- or <span class="highlight">HER2</span> <span class="highlight">low)</span> breast cancer that is PD-L1 negative who have received no more than one line of therapy for metastatic disease. You must not have received immunotherapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STEMVAC vaccine with sargramostim, by injection, once a month for 3 months</li> <li class="seamTextUnorderedListItem">Standard chemotherapy chosen by your doctor</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Followed by:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 booster vaccines, by injection, 4 months and 7 months after the last treatment </li> <li class="seamTextUnorderedListItem">Ongoing booster vaccine, every 6 months, up to 3 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers want to learn if the vaccine helps the immune system recognize and attack breast cancer cells by targeting specific proteins found on the cancer cells.</li> <li class="seamTextUnorderedListItem">Standard chemotherapy options may include medicines such as paclitaxel, docetaxel, carboplatin, cisplatin, doxorubicin, liposomal doxorubicin, or eribulin.</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/NCT07078604' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/vaccines-mbc/' target='_blank'>Metastatic Trial Talk: All About Vaccines for MBC</a> </li></ul>
14

STEMVAC Vaccine in Combination With Chemo for Metastatic Triple-Negative Breast Cancer that is PD-L1 Negative

A Phase II Trial of the Immunogenicity of a DNA Plasmid-Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer
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Nearest Location from 94107:
682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA

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Visits:
Every 1-3 weeks for 3 months, then every 6 months for up to 3 years

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ClinicalTrials.gov: NCT07078604

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Phase II

15

GS-0201 Alone or With ADC for Advanced Triple Negative or HR+, HER2- Breast Cancer

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-0201 as Monotherapy and in Combination in Adults With Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of GS-0201, an experimental anti-cancer therapy, alone or with sacituzumab govitecan (Trodelvy®) antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone receptor positive (ER+ and/or PR+), <span class="highlight">HER2</span> negative (HER2- or <span class="highlight">HER2</span> <span class="highlight">low)</span> breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GS-0201, by mouth</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GS-0201 is an experimental anti-cancer therapy.</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 the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+ 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/NCT06167317' target='_blank'>ClinicalTrials.gov</a> </li></ul>
15

GS-0201 Alone or With ADC for Advanced Triple Negative or HR+, HER2- Breast Cancer

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-0201 as Monotherapy and in Combination in Adults With Advanced Solid Tumors
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Nearest Location from 94107:
1471 miles
NEXT Dallas
Irving, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06167317

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Phase I

16

EP0062 Hormone Therapy for Advanced ER+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low,</span> AR+ Breast Cancer

A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients With Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of EP0062, an experimental hormone therapy.

Who is this for?: Postmenopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), <span class="highlight">HER2</span> negative (HER2-) or <span class="highlight">HER2</span> <span class="highlight">low,</span> androgen receptor positive (AR+) breast cancer with 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">EP0062, 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">EP0062 is an experimental type of hormone therapy called a selective androgen receptor modulator (SARM) that targets the androgen receptor (AR).</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+ or 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/NCT05573126' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ellipses.life/portfolio/' target='_blank'>Ellipses Pharma: EP0062 Drug Information Page</a> </li></ul>
16

EP0062 Hormone Therapy for Advanced ER+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low,</span> AR+ Breast Cancer

A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients With Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer
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Nearest Location from 94107:
1482 miles
Texas Oncology Baylor University Medical Center
Dallas, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05573126

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Phase I-II

17

Hormone Therapy or Chemotherapy with Genetic Testing for Metastatic HR+, HER2- Breast Cancer

Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of hormone therapy and capecitabine (Xeloda®) chemotherapy and use MammaPrint® and BluePrint tests to guide treatment decisions.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), <span class="highlight">HER2</span> negative (HER2-) breast cancer who have received treatment with hormone therapy and a CDK4/6 inhibitor. You must not have received chemotherapy or more than 1 line of hormone therapy for advanced disease or have a PIK3CA mutation. 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: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 1 week on, 1 week off</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests</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">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">MammaPrint® and BluePrint are genetic tests that use tumor samples to help guide treatment decisions.</li> <li class="seamTextUnorderedListItem">The tests will also be used to determine if certain mutations are potentially associated with resistance to therapy.</li> <li class="seamTextUnorderedListItem">This trial is for people with non-Luminal A breast cancer. Luminal A breast cancer is ER+, PR+, and HER2- with <span class="highlight">low</span> Ki-67 levels, which controls how fast cancer cells grow. Luminal A cancers tend to grow more slowly.</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/NCT05693766' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/molecular-subtypes' target='_blank'>Breastcancer.org: Molecular Subtypes of Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/genetic-testing' target='_blank'>Breastcancer.org: Genetic Testing for Breast Cancer</a> </li></ul>
17

Hormone Therapy or Chemotherapy with Genetic Testing for Metastatic HR+, HER2- Breast Cancer

Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)
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Nearest Location from 94107:
1509 miles
UT Southwestern Medical Center
Dallas, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05693766

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Phase II

18

BAL0891 Targeted Therapy Alone or With Chemotherapy for Advanced Triple Negative Breast Cancer

A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of BAL0891, an experimental TTK/PLK inhibitor, alone or with chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER <span class="highlight">low,</span> PR- or ER <span class="highlight">low,</span> HER2- or <span class="highlight">HER2</span> <span class="highlight">low)</span> breast cancer who have received at least 1 line of therapy for advanced disease. You must not have received more than 4 lines of 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</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAL0891, by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAL0891, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAL0891 is an experimental targeted therapy called a TTK/PLK inhibitor. Blocking TTK/PLK may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> 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/NCT05768932' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.sillajen.com/eng/sub/pipeline_bal0891.html' target='_blank'>SillaJen: BAL0891 Drug Information Page</a> </li></ul>
18

BAL0891 Targeted Therapy Alone or With Chemotherapy for Advanced Triple Negative Breast Cancer

A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced Solid Tumors
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Nearest Location from 94107:
1643 miles
The University of Texas MD Anderson Cancer Center
Houston, TX

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05768932

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Phase I

19

Fulvestrant With Abemaciclib for ER+ or ER <span class="highlight">Low,</span> HER2- Metastatic Breast Cancer

Multicenter Randomized Phase II Trial of Fulvestrant Plus Abemaciclib With or Without Run-in of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer After Failure of a CDK4/6 Inhibitor In Combination With an Aromatase Inhibitor

Purpose: To determine if stopping treatment with abemaciclib (Verzenio®) for 1 month (called a drug holiday) improves the effects (good and bad) and anti-cancer activity of abemaciclib (Verzenio®) with fulvestrant (Faslodex®).

Who is this for?: Women with metastatic (stage IV) ER positive (ER+) or ER <span class="highlight">Low</span> (1%-10% ER), <span class="highlight">HER2</span> negative (HER2-) breast cancer that has progressed on a CDK4/6 inhibitor in combination with an aromatase inhibitor immediately before enrolling in this study. 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">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then once a month </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</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). It is approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">A drug holiday is a planned period of time that you decide with your doctor to stop taking a medication. In some cases, a drug holiday can allow a medication to become effective again.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put you in temporary menopause.</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/NCT05305924' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verywellhealth.com/drug-holiday-definition-risks-and-benefits-2248870' target='_blank'>Verywell Health: Drug Holiday</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/pathology-report/hormone-receptor-status' target='_blank'>Breastcancer.org: Hormone Receptor Status</a> </li></ul>
19

Fulvestrant With Abemaciclib for ER+ or ER <span class="highlight">Low,</span> HER2- Metastatic Breast Cancer

Multicenter Randomized Phase II Trial of Fulvestrant Plus Abemaciclib With or Without Run-in of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer After Failure of a CDK4/6 Inhibitor In Combination With an Aromatase Inhibitor
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Nearest Location from 94107:
1643 miles
Houston Methodist Cancer Center
Houston, TX

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Visits:
2 visits the first month, then 1 visit a month, ongoing

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ClinicalTrials.gov: NCT05305924

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Phase II

20

Biomarkers to Detect Resistance to Hormone Therapy for Advanced HR+, HER2- Lobular Breast Cancer

Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer

Purpose: To identify possible biomarkers of response to hormone therapy for advanced lobular breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ or ER <span class="highlight">low</span> and/or PR+ or PR <span class="highlight">low),</span> <span class="highlight">HER2</span> negative (HER2-) lobular breast cancer (LBC) who are planning to receive hormone therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/CT scans with 18F-FFNP, by IV, 2 times, at baseline and at 1 month</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times, at baseline and at 1 month</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biomarkers are genes, molecules, or other features present in a person, including in a person’s tumor, that tell doctors something about a person’s health condition.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">The tracer used in this study is 18F-FFNP.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy. MRI scans study the blood vessels in the tumor. PET/CT scans study if the tumor cells are growing.</li> <li class="seamTextUnorderedListItem">The blood samples will be used to conduct DNA and circulating tumor cell (CTC) testing.</li> <li class="seamTextUnorderedListItem">Circulating tumor cells (CTCs) are cancer cells from a tumor that circulate in the bloodstream.</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/NCT06067503' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment' target='_blank'>National Cancer Institute: Biomarker Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/pet-scans' target='_blank'>Breastcancer.org: PET Scans</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/ct-scan' target='_blank'>Breastcancer.org: CT Scans</a> </li></ul>
20

Biomarkers to Detect Resistance to Hormone Therapy for Advanced HR+, HER2- Lobular Breast Cancer

Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer
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Nearest Location from 94107:
1678 miles
UW Carbone Cancer Center
Madison, WI

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Visits:
2 visits within 1 month

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ClinicalTrials.gov: NCT06067503

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Phase II

21

Biomarker Test to Change or Continue Treatment for Advanced HR+, HER2- Breast Cancer

BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer

Purpose: To use the DiviTum® TKa blood test to determine if people with advanced HR+, HER2- breast cancer should continue or switch treatments.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), <span class="highlight">HER2</span> negative (HER2-) breast cancer who have not yet received treatment for advanced disease. You must be planning to receive hormone therapy with a CDK4/6 inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups depending on results of the DiviTum® TKa blood tests: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Suppressed (Low) TKa Levels</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum® TKa blood test, 4 times within 4 months</li> <li class="seamTextUnorderedListItem">Continue on endocrine therapy and CDK4/6 inhibitor (i.e., Ribociclib)</li> <li class="seamTextUnorderedListItem">Imaging scans</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Unsuppressed (Not <span class="highlight">Low)</span> TKa Levels</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum® TKa blood test, 4 times within 4 months</li> <li class="seamTextUnorderedListItem">Switch treatment</li> <li class="seamTextUnorderedListItem">Imaging scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum® TKa blood test is a blood test that measures thymidine kinase activity (TKa) which may predict how well tumors respond to treatment.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05977036' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://biovica.com/divitum/' target='_blank'>Biovica: DiviTum® Test</a> </li></ul>
21

Biomarker Test to Change or Continue Treatment for Advanced HR+, HER2- Breast Cancer

BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer
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Nearest Location from 94107:
1739 miles
Washington University School of Medicine
St Louis, MO

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Visits:
At least 4 visits within 4 months

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ClinicalTrials.gov: NCT05977036

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Phase NA

22

Sacituzumab Govitecan with or without Pembrolizumab for Advanced Triple Negative or ER <span class="highlight">Low,</span> HER2- Breast Cancer

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-. HER2-) or ER <span class="highlight">Low</span> (1%-10% ER), <span class="highlight">HER2</span> negative breast cancer that is PD-L1 negative, who have not yet started treatment for metastatic 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">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells. </li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. </li> <li class="seamTextUnorderedListItem">It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved for use in people with metastatic triple negative breast cancer who have already received at least two other therapies for metastatic disease. But its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER <span class="highlight">Low.</span> This trial is enrolling people with triple negative as well as ER <span class="highlight">Low,</span> <span class="highlight">HER2</span> negative breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04468061' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-sacituzumab-govitecan-triple-negative-breast-cancer' target='_blank'>NCI Cancer Currents Blog: Sacituzumab Govitecan Approved for Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/dosing' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/pembrolizumab' target='_blank'>Cancer Research UK: Pembrolizumab (Keytruda)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/lab-tests/pdl1-immunotherapy-tests/' target='_blank'>NIH MedlinePlus: PDL1 (Immunotherapy) Tests</a> </li></ul>
22

Sacituzumab Govitecan with or without Pembrolizumab for Advanced Triple Negative or ER <span class="highlight">Low,</span> HER2- Breast Cancer

Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)
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Nearest Location from 94107:
1857 miles
University of Chicago Medical Center
Chicago, IL

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Visits:
2 visits every 3 weeks

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ClinicalTrials.gov: NCT04468061

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Phase II

23

Chemotherapy Alone or With Immunotherapy for Advanced Triple Negative, PD-L1 Negative Breast Cancer

A Phase II Trial of Carboplatin +/- Tocilizumab as Initial Therapy for Metastatic Triple Negative and ER-low Breast Cancers

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of carboplatin (Paraplatin®) chemotherapy alone or with tocilizumab, an experimental immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER <span class="highlight">low,</span> PR-, HER2- or <span class="highlight">HER2</span> <span class="highlight">low),</span> PD-L1 negative breast cancer who have not received chemotherapy 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">Carboplatin (Paraplatin®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tocilizumab, by IV, monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Tocilizumab is an experimental immunotherapy called an IL-6 inhibitor that is approved to treat arthritis. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+ and 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/NCT05846789' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/carboplatin' target='_blank'>Breastcancer.org: Carboplatin (Paraplatin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a611004.html' target='_blank'>MedlinePlus: Tocilizumab</a> </li></ul>
23

Chemotherapy Alone or With Immunotherapy for Advanced Triple Negative, PD-L1 Negative Breast Cancer

A Phase II Trial of Carboplatin +/- Tocilizumab as Initial Therapy for Metastatic Triple Negative and ER-low Breast Cancers
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Nearest Location from 94107:
1944 miles
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, IN

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Visits:
1-2 visits every month

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ClinicalTrials.gov: NCT05846789

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Phase II

24

<span class="highlight">Low</span> Dose Capecitabine Chemotherapy for People with Advanced HR+, HER2- or Triple Negative Breast Cancer

Phase II Single Arm Trial of <span class="highlight">Low</span> Dose Capecitabine in Patients with Advanced Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of a <span class="highlight">lower</span> dose of capecitabine (Xeloda®) chemotherapy for older or frail (weak) people with advanced breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), <span class="highlight">HER2</span> negative (HER2- or <span class="highlight">HER2</span> <span class="highlight">low)</span> or triple negative (ER-, PR-, HER2- or <span class="highlight">HER2</span> <span class="highlight">low)</span> breast cancer who have received at least 1 line of therapy for advanced disease. You must be frail (weak) or at least 60 years old. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Low</span> dose capecitabine (Xeloda®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">In this trial, frail is defined as having a greater risk of complications and poorer outcomes because of illness, injury, or age.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">A <span class="highlight">lower</span> dose of capecitabine (Xeloda®) may be better for frail and older people.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+ or 2+.</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/NCT06105684' target='_blank'>ClinicalTrials.gov</a> </li></ul>
24

<span class="highlight">Low</span> Dose Capecitabine Chemotherapy for People with Advanced HR+, HER2- or Triple Negative Breast Cancer

Phase II Single Arm Trial of <span class="highlight">Low</span> Dose Capecitabine in Patients with Advanced Breast Cancer
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Nearest Location from 94107:
2013 miles
University of Alabama at Birmingham
Birmingham, AL

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Visits:
At least 2 times in 3 months

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ClinicalTrials.gov: NCT06105684

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Phase II

25

Leuprolide or Goserelin to Reduce Estrogen for Pre- or Peri-Menopausal Women With Stage I-IV Breast Cancer

Phase 2 Randomized Trial to Examine Ovarian Function Suppression for Breast Cancer (OFS)

Purpose: To compare a <span class="highlight">low</span> dose of leuprolide (Lupron®), a high dose of leuprolide (Lupron®), and goserelin (Zoladex®) for their ability to reduce estrogen production.

Who is this for?: Pre-menopausal or peri-menopausal women with stage I, stage II, stage III, or stage IV (metastatic) hormone receptor positive (ER+ and/or PR+), <span class="highlight">HER2</span> negative (HER2-) breast cancer who are planning to receive a gonadotropin releasing hormone (GnRH) agonist plus hormone therapy. You must have completed chemotherapy if recommended. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leuprolide (Lupron®), <span class="highlight">low</span> dose, by injection, monthly for 6 months</li> <li class="seamTextUnorderedListItem">Blood tests</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leuprolide (Lupron®), high dose, by injection, monthly for 6 months</li> <li class="seamTextUnorderedListItem">Blood tests</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®), by injection, monthly for 6 months</li> <li class="seamTextUnorderedListItem">Blood tests</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leuprolide (Lupron®) and goserelin (Zoladex®) are given to pre-menopausal and peri-menopausal women with HR+ breast cancer. These drugs block the ability of the ovaries to make estrogen, which causes HR+ breast cancer to 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/NCT07158021' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zoladex.com/?gclsrc=aw.ds&gad_source=1&gad_campaignid=22507845007&gbraid=0AAAAA_gRoNBb5XSY7s8DD7IIxTBZtXTv6&gclid=Cj0KCQiAoZDJBhC0ARIsAERP-F-ABUsC3lGhM3VH4Nc4qtBUZY8e6bBS1dm4GjfxXphAdMMFnwMJfWgaAkRAEALw_wcB' target='_blank'>AstraZeneca: Goserelin (Zoladex®)</a> </li></ul>
25

Leuprolide or Goserelin to Reduce Estrogen for Pre- or Peri-Menopausal Women With Stage I-IV Breast Cancer

Phase 2 Randomized Trial to Examine Ovarian Function Suppression for Breast Cancer (OFS)
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Nearest Location from 94107:
2054 miles
University of Michigan Comprehensive Cancer Center
Ann Arbor, MI

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Visits:
Monthly for 6 months

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ClinicalTrials.gov: NCT07158021

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Phase II

26

Liquid Biopsy to Monitor Treatment Response for Women with Metastatic Lobular ER+ Breast Cancer

LBC-Monitor: Liquid Biopsy Guided Tailoring of Therapy in Metastatic Lobular Breast Cancer (mILC): a Pilot Study of Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA

Purpose: To study how circulating tumor DNA (ctDNA) changes over time to help monitor treatment response and make treatment decisions.

Who is this for?: Women with metastatic (stage IV) estrogen receptor positive (ER+) or ER <span class="highlight">low,</span> <span class="highlight">HER2</span> negative (HER2-) lobular breast cancer who have not yet received treatment for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests, 4 times in 3 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lobular breast cancer can be difficult to see and monitor on scans.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">A ctDNA test is sometimes called a liquid biopsy.</li> <li class="seamTextUnorderedListItem">ctDNA tests may improve the ability to monitor treatment response in lobular breast cancer and identify changes in the tumor cells that may predict resistance to hormone therapy.</li> <li class="seamTextUnorderedListItem">This information may allow doctors to change treatments when it is most beneficial to patients.</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/NCT06666439' target='_blank'>ClinicalTrials.gov</a> </li></ul>
26

Liquid Biopsy to Monitor Treatment Response for Women with Metastatic Lobular ER+ Breast Cancer

LBC-Monitor: Liquid Biopsy Guided Tailoring of Therapy in Metastatic Lobular Breast Cancer (mILC): a Pilot Study of Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA
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Nearest Location from 94107:
2264 miles
Magee Women's Hospital of UPMC
Pittsburgh, PA

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Visits:
4 visits in 3 months

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ClinicalTrials.gov: NCT06666439

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Phase NA

27

Tamoxifen Hormone Therapy and Liposomal Doxorubicin Chemotherapy for Advanced Triple Negative Breast Cancer

A Pilot, Single-Arm, Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of tamoxifen (Nolvadex®) hormone therapy with pegylated liposomal doxorubicin (Doxil®) chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER <span class="highlight">low,</span> PR-, HER2- or <span class="highlight">HER2</span> <span class="highlight">low)</span> breast cancer who have received at least 2 lines of therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pegylated liposomal doxorubicin (Doxil®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Electrocardiogram (ECG)</li> <li class="seamTextUnorderedListItem">CT scan or MRI scan</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen which may help stop the growth of tumor cells that need estrogen to grow.</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) is a type of chemotherapy drug that damages cancer cell DNA and blocks a protein (enzyme) needed for cancer cell division and DNA repair.</li> <li class="seamTextUnorderedListItem">Liposomal doxorubicin is a form of the drug that is contained inside very tiny, fat-like particles.</li> <li class="seamTextUnorderedListItem">Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. </li> <li class="seamTextUnorderedListItem">Giving tamoxifen and pegylated liposomal doxorubicin together may work better than giving either drug alone.</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">An electrocardiogram (ECG) is a way of recording the heart's electrical activity.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is 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/NCT06434064' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/treatment/drugs/pegylated-liposomal-doxorubicin' target='_blank'>Cancer Research UK: Pegylated Liposomal Doxorubicin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li></ul>
27

Tamoxifen Hormone Therapy and Liposomal Doxorubicin Chemotherapy for Advanced Triple Negative Breast Cancer

A Pilot, Single-Arm, Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative Breast Cancer
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Nearest Location from 94107:
2299 miles
Roswell Park Cancer Institute
Buffalo, NY

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Visits:
1 visit every month

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ClinicalTrials.gov: NCT06434064

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Phase II

28

Trastuzumab Deruxtecan Antibody Drug Conjugate for Advanced <span class="highlight">HER2</span> 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 (Enhertu®, T-DXd) antibody drug conjugate for people with metastatic <span class="highlight">HER2</span> negative breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) <span class="highlight">HER2</span> 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 <span class="highlight">HER2</span> 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 (Enhertu®, T-DXd), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">About half of breast cancers that are considered <span class="highlight">HER2</span> negative actually have <span class="highlight">low</span> expression of <span class="highlight">HER2</span> <span class="highlight">(HER2</span> <span class="highlight">low)</span> and may respond to anti-HER2 targeted therapies.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan is effective and increases survival in people with <span class="highlight">HER2</span> <span class="highlight">low</span> breast cancers.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets <span class="highlight">HER2</span> 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>
28

Trastuzumab Deruxtecan Antibody Drug Conjugate for Advanced <span class="highlight">HER2</span> 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 from 94107:
2352 miles
University of Rochester Medical Center
Rochester, NY

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT06750484

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Phase II

29

Dendritic Cell Vaccine and Hormone Therapy for Metastatic HR+, HER2- Breast Cancer with ESR1 Mutations

Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of an experimental dendritic cell vaccine with elacestrant (Orserdu®) hormone therapy.

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ or ER <span class="highlight">low</span> and/or PR+ or PR <span class="highlight">low),</span> <span class="highlight">HER2</span> negative (HER2- or <span class="highlight">HER2</span> <span class="highlight">low)</span> breast cancer with ESR1 mutations. You must have received a CDK4/6 inhibitor with hormone therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to remove white blood cells, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, weekly for 2 months then monthly for 3 months</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is an experimental immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">You will receive a dendritic cell vaccine made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The white blood cells, called dendritic cells, are removed from your body during a procedure called apheresis. These cells are processed in a lab so that they will see and go after cancer cells with ESR1 mutations, and then they will be injected as a vaccine.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is considered standard of care for patients with ESR1 mutated HR+ HER2-metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+ or IHC 2/ISH-.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</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/NCT06691035' target='_blank'>ClinicalTrials.gov</a> </li></ul>
29

Dendritic Cell Vaccine and Hormone Therapy for Metastatic HR+, HER2- Breast Cancer with ESR1 Mutations

Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing Metastatic Breast Cancer
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Nearest Location from 94107:
2395 miles
Moffitt Cancer Center
Tampa, FL

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Visits:
Weekly for 2 months then monthly for 3 months

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ClinicalTrials.gov: NCT06691035

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Phase I

30

CAR-T Cells for Advanced Triple Negative Breast Cancer

Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of an experimental CAR-T cell therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER <span class="highlight">low,</span> PR- or PR <span class="highlight">low,</span> HER2- or <span class="highlight">HER2</span> <span class="highlight">low)</span> breast cancer. 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">Fludarabine (Fludara®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR-T cell therapy, by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR-T or CAR T cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The CAR T cells are then infused back into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">The CAR T cell therapy being used in this study trains the immune system to attack B7-H3 expressing cancer cells.</li> <li class="seamTextUnorderedListItem">HER2 <span class="highlight">low</span> is defined as IHC 1+.</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/NCT06347068' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li></ul>
30

CAR-T Cells for Advanced Triple Negative Breast Cancer

Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer
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Nearest Location from 94107:
2406 miles
University of North Carolina
Chapel Hill, NC

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT06347068

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Phase I

31

AG01 Targeted Therapy for Advanced HER2-/HER2 <span class="highlight">Low</span> Breast Cancer That Expresses GP88

FIH Phase 1A /1B Study of AG01 Antibody Against Progranulin/GP88 in Advanced Solid Tumor Malignancies With Expansion Cohorts in Advanced Triple Negative Breast Ca, Hormone Resistant Breast Ca, Non Small Cell Lung Cancer and Mesothelioma

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of AG01, an experimental PGRN/GP88 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) <span class="highlight">HER2</span> negative (HER2-) or <span class="highlight">HER2</span> <span class="highlight">low</span> breast cancer that expresses GP88. You must have received standard treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AG01, by IV, every 2 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AG01 is an experimental targeted therapy called a PGRN/GP88 inhibitor. Blocking PGRN/GP88 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+ or 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: GP88</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/NCT05627960' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abstractsonline.com/pp8/#!/10462/presentation/1702' target='_blank'>SABCS 2021 Abstract: AG01 Inhibits Growth of Triple Negative Breast Cancer Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/33616772/' target='_blank'>Journal Article: AG01 Inhibits Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li></ul>
31

AG01 Targeted Therapy for Advanced HER2-/HER2 <span class="highlight">Low</span> Breast Cancer That Expresses GP88

FIH Phase 1A /1B Study of AG01 Antibody Against Progranulin/GP88 in Advanced Solid Tumor Malignancies With Expansion Cohorts in Advanced Triple Negative Breast Ca, Hormone Resistant Breast Ca, Non Small Cell Lung Cancer and Mesothelioma
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Nearest Location from 94107:
2452 miles
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, MD

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Visits:
1 visit every 2 weeks

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ClinicalTrials.gov: NCT05627960

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Phase I

32

Evexomostat and Chemotherapy for People with Advanced Triple Negative Breast Cancer and High Blood Sugar or High BMI

Phase 2 Randomized Control Trial of Evexomostat (SDX-7320) in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of eribulin (Halaven®) chemotherapy with or without evexomostat (SDX-7320), an experimental polymer drug conjugate.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2- or <span class="highlight">HER2</span> <span class="highlight">low)</span> breast cancer who have high blood sugar or a BMI of at least 30 kg/m^2. You must have received chemotherapy and must not have received more than 2 lines of therapy for advanced or metastatic 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">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320), by injection, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Placebo for evexomostat (SDX-7320)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) is an experimental polymer drug conjugate (PDC), which is similar to an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) releases fumagillol, a type of targeted therapy called a MetAP2 inhibitor. Blocking MetAP2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+.</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/NCT05570253' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aretha1.com/' target='_blank'>SynDevRx: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/lead-compound-sdx-7320/' target='_blank'>SynDevRx Drug Information Page: Evexomostat (SDX-7320)</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/science/polymer-drug-conjugation/' target='_blank'>SynDevRx: Polymer Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/halaven' target='_blank'>Breastcancer.org: Eribulin (Halaven®)</a> </li></ul>
32

Evexomostat and Chemotherapy for People with Advanced Triple Negative Breast Cancer and High Blood Sugar or High BMI

Phase 2 Randomized Control Trial of Evexomostat (SDX-7320) in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study
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Nearest Location from 94107:
2539 miles
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, NJ

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Visits:
1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT05570253

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Phase II

33

Targeted Therapy and Hormone Therapy for Advanced ER+ or ER <span class="highlight">Low,</span> HER2- Breast Cancer

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of lenvatinib (Lenvima®) tyrosine kinase inhibitor, pembrolizumab (Keytruda®) PD-1 inhibitor, and fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER <span class="highlight">low,</span> <span class="highlight">HER2</span> negative (HER2-) breast cancer who have received hormone therapy with a CDK4/6 inhibitor for advanced disease. You must not have received more than 2 lines of chemotherapy for advanced disease or a PD-1/PD-L1 inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by IV, monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) 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">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">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</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/NCT06110793' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615015.html' target='_blank'>MedlinePlus: Lenvatinib (Lenvima®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
33

Targeted Therapy and Hormone Therapy for Advanced ER+ or ER <span class="highlight">Low,</span> HER2- Breast Cancer

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer
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Nearest Location from 94107:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
1 visit every month

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ClinicalTrials.gov: NCT06110793

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Phase I-II

34

Trastuzumab Deruxtecan ADC for People with Advanced <span class="highlight">HER2</span> Negative or <span class="highlight">HER2</span> <span class="highlight">Low</span> 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 <span class="highlight">HER2</span> 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, Enhertu®) antibody drug conjugate (ADC) for advanced <span class="highlight">HER2</span> negative or <span class="highlight">HER2</span> <span class="highlight">low</span> breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with <span class="highlight">HER2</span> negative (IHC 0) or <span class="highlight">HER2</span> <span class="highlight">low</span> (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, Enhertu®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®) is a type of immunotherapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) uses the HER2-targeted antibody 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>
34

Trastuzumab Deruxtecan ADC for People with Advanced <span class="highlight">HER2</span> Negative or <span class="highlight">HER2</span> <span class="highlight">Low</span> 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 <span class="highlight">HER2</span> Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)
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Nearest Location from 94107:
2549 miles
Overlook Medical Center
Summit, NJ

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05950945

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Phase III

35

Stereotactic Body Radiation Therapy for Metastatic HER2+, <span class="highlight">HER2</span> <span class="highlight">Low,</span> or ER+, HER2- Breast Cancer

Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of stereotactic body radiotherapy (SBRT).

Who is this for?: People with metastatic (stage IV) <span class="highlight">HER2</span> positive (HER2+), <span class="highlight">HER2</span> <span class="highlight">low,</span> or estrogen receptor positive (ER+), <span class="highlight">HER2</span> negative (HER2-) breast cancer. You must have a small number of metastases (oligometastatic disease) and have received standard treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic body radiotherapy (SBRT), 3-5 sessions</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oligometastatic breast cancer is metastatic breast cancer with a small number of metastases.</li> <li class="seamTextUnorderedListItem">Stereotactic body radiotherapy (SBRT) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">During this trial, you will continue your current line of 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/NCT05534438' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.uclahealth.org/departments/radonc/research-technologies/innovation-technology/external-beam-radiation-therapy-ebrt/stereotactic-body-radiation-therapy-sbrt/faqs-sbrt' target='_blank'>UCLA Health: Stereotactic Body Radiation Therapy (SBRT)</a> </li></ul>
35

Stereotactic Body Radiation Therapy for Metastatic HER2+, <span class="highlight">HER2</span> <span class="highlight">Low,</span> or ER+, HER2- Breast Cancer

Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
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Nearest Location from 94107:
2561 miles
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, NJ

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Visits:
3-5 visits within 1 week

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ClinicalTrials.gov: NCT05534438

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Phase II

36

Hormone Therapy and Targeted Therapy Based on Biomarker Testing for Advanced ER+, HER2- Breast Cancer

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of hormone therapy and targeted therapy based on biomarker testing.

Who is this for?: Post-menopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER <span class="highlight">low,</span> <span class="highlight">HER2</span> negative (HER2-) or <span class="highlight">HER2</span> <span class="highlight">low</span> breast cancer. You must have received treatment with palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®) for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 4 groups based on biomarker testing results: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive treatment based on ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1 biomarker testing results.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells from growing by targeting and blocking the <span class="highlight">HER2</span> proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+ or 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/NCT05933395' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>
36

Hormone Therapy and Targeted Therapy Based on Biomarker Testing for Advanced ER+, HER2- Breast Cancer

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)
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Nearest Location from 94107:
2619 miles
Dartmouth Hitchcock Medical Center
Lebanon, NH

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Visits:
1 visit every month

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ClinicalTrials.gov: NCT05933395

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Phase II

37

Axatilimab Immunotherapy with Targeted Therapy for Advanced <span class="highlight">HER2</span> Negative Breast Cancer with BRCA1/2 or PALB2 Mutations

Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

Purpose: To study the safety, best dose, and effects (good and bad) of axatilimab, an experimental immunotherapy, with olaparib (Lynparza®) PARP inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) <span class="highlight">HER2</span> negative (HER2-) or <span class="highlight">HER2</span> <span class="highlight">low</span> breast cancer with tumor or inherited BRCA1 or BRCA2 mutations or inherited PALB2 mutations. You must not have received more than 2 lines of chemotherapy, antibody drug conjugates (ADC), and/or immunotherapy 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">Axatilimab, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily</li> <li class="seamTextUnorderedListItem">MRI and/or CT scans, every 2 months</li> <li class="seamTextUnorderedListItem">Electrocardiograms</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Axatilimab is an experimental immunotherapy drug that may help the immune system go after and kill cancer drugs.</li> <li class="seamTextUnorderedListItem">Axatilimab is approved to treat Graft-Versus-Host Disease (GVHD), and its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</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">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">An electrocardiogram (ECG) test records electrical signals in your heart.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is defined as IHC 1+ 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/NCT06488378' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/clinical-trials/24-155' target='_blank'>Dana-Farber Cancer Institute: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/axatilimab' target='_blank'>National Cancer Institute: Axatilimab</a> </li></ul>
37

Axatilimab Immunotherapy with Targeted Therapy for Advanced <span class="highlight">HER2</span> Negative Breast Cancer with BRCA1/2 or PALB2 Mutations

Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
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Nearest Location from 94107:
2693 miles
Brigham and Women's Hospital
Boston, MA

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Visits:
1 visit every 2 weeks

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ClinicalTrials.gov: NCT06488378

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Phase I

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