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1

Vepdegestrant Hormone Therapy with Samuraciclib CDK7 Inhibitor for Advanced ER+ or ER <span class="highlight">Low,</span> HER2- Breast Cancer

TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANC...

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of vepdegestrant (ARV-471), an experimental hormone therapy, with samuraciclib, an experimental CDK7 inhibitor.

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 up to 2 lines of therapy for advanced disease. You must have received a CDK4/6 inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vepdegestrant (ARV-471), by mouth, daily</li> <li class="seamTextUnorderedListItem">Samuraciclib, by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vepdegestrant (ARV-471) is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Samuraciclib is an experimental targeted therapy called a CDK7 inhibitor. CDK7 inhibitors may block the CDK7 enzyme that helps cancer 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/NCT06125522' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/nct05548127-or-nct05573555-advanced-and-metastatic-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arvinas.com/pipeline-programs/estrogen-receptor' target='_blank'>Arvinas Estrogen Receptor: ARV-471 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.carricktherapeutics.com/pipeline/cdk7-inhibitor' target='_blank'>Carrick Therapeutics: Samuraciclib Drug Information Page</a> </li></ul>
1

Vepdegestrant Hormone Therapy with Samuraciclib CDK7 Inhibitor for Advanced ER+ or ER <span class="highlight">Low,</span> HER2- Breast Cancer

TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANC...
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Nearest Location:
28 miles
Stanford Cancer Institute - Clinical Trials Office
Palo Alto, CA

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Visits:
1 visit every month

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ClinicalTrials.gov: NCT06125522

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Phase I-II

2

Vepdegestrant Hormone Therapy with PF-07220060 CDK4 Inhibitor for Advanced ER+ or ER <span class="highlight">Low,</span> HER2- Breast Cancer

AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH PF-07220060 IN PARTICIPANTS AGED 18 YEARS AND OLDER WITH ER+/HER2- ADVANCED OR METASTATIC BREAST CANCER

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of vepdegestrant, an experimental hormone therapy, with PF-07220060, an experimental CDK4 inhibitor.

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 a CDK4/6 inhibitor and at least 1 line of therapy for advanced disease. You must not have received more than 2 lines of hormone therapy or 1 line of chemotherapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vepdegestrant (ARV-471), by mouth, daily</li> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vepdegestrant (ARV-471) is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">PF-07220060 is an experimental targeted therapy called a CDK4 inhibitor. CDK4 is a protein that helps cancer grow. Blocking CDK4 helps slow or stop cancer cells from growing.</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/NCT06206837' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct06206837-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arvinas.com/pipeline-programs/estrogen-receptor' target='_blank'>Arvinas Estrogen Receptor: ARV-471 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://cdn.pfizer.com/pfizercom/product-pipeline/Pipeline_Update_04MAY2021.pdf?VersionId=.06Q_HtLdkBW8lme0Y3EXpraBpgGspyg' target='_blank'>Pfizer: PF-07220060 Drug Information Page</a> </li></ul>
2

Vepdegestrant Hormone Therapy with PF-07220060 CDK4 Inhibitor for Advanced ER+ or ER <span class="highlight">Low,</span> HER2- Breast Cancer

AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH PF-07220060 IN PARTICIPANTS AGED 18 YEARS AND OLDER WITH ER+/HER2- ADVANCED OR METASTATIC BREAST CANCER
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Nearest Location:
28 miles
Clinical and Translational Research Unit (CTRU)
Palo Alto, CA

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Visits:
1 visit every month

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ClinicalTrials.gov: NCT06206837

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Phase I-II

3

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>
3

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:
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

4

RYZ101 Radioactive Drug with Immunotherapy for Advanced ER+, HER2- Breast Cancer Expressing SSTRs

Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) Alone and in Combination with Pembrolizumab in Subjects with Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates And/or Chemotherapy (TRACY-1)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of RYZ101, an experimental radioactive drug, with pembrolizumab (Keytruda®) immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor (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 that expresses somatostatin receptors (SSTRs) 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">225Ac-DOTATATE (RYZ101)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</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">225Ac-DOTATATE (RYZ101) is an experimental radiopharmaceutical or radioactive drug.</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">Somatostatin receptors (SSTRs) are a type of biomarker your tumor may have. Ask your doctor and/or check your pathology report to know if your cancer expresses somatostatin receptors (SSTRs).</li> <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">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/NCT06590857' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/radiopharmaceuticals-cancer-radiation-therapy#:~:text=Once%20a%20radiopharmaceutical%20has%20stuck,irreparably%20damaged%2C%20that%20cell%20dies' target='_blank'>National Cancer Institute: Radiopharmaceuticals</a> </li></ul>
4

RYZ101 Radioactive Drug with Immunotherapy for Advanced ER+, HER2- Breast Cancer Expressing SSTRs

Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) Alone and in Combination with Pembrolizumab in Subjects with Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates And/or Chemotherapy (TRACY-1)
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Nearest Location:
339 miles
Research Facility
Santa Monica, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06590857

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Phase I-II

5

PBA-0405 Targeted Therapy for Stage I-IV Triple Negative Breast Cancer

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors (PB004)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of PBA-0405, an experimental ROR1 inhibitor.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) triple negative (ER-, PR-, HER2- or <span class="highlight">HER2</span> <span class="highlight">low)</span> breast cancer who are planning to receive surgery. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PBA-0405, by injection into tumor with CIVO device, 1-2 days before surgery</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PBA-0405 is an experimental targeted therapy called a ROR1 inhibitor. Blocking ROR1 may slow or stop cancer cells from growing. PBA-0405 may also help the immune system attack and kill tumor cells.</li> <li class="seamTextUnorderedListItem">The CIVO device helps the doctor inject the drug into a tumor or lymph node.</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/NCT06273852' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://presagebio.com/civo-platform/' target='_blank'>Presage Biosciences: CIVO Device</a> </li><li class='seamTextUnorderedListItem'><a href='https://purebiologics.com/project/pb004-purebike/' target='_blank'>Pure Biologics: PBA-0405 Drug Information Page</a> </li></ul>
5

PBA-0405 Targeted Therapy for Stage I-IV Triple Negative Breast Cancer

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors (PB004)
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Nearest Location:
533 miles
Oregon Health and Science University
Portland, OR

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Visits:
1 visit

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ClinicalTrials.gov: NCT06273852

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Phase I

6

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>
6

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:
533 miles
OHSU Knight Cancer Institute
Portland, OR

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05768932

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Phase I

7

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>
7

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:
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

8

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>
8

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:
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

9

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>
9

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:
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

10

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>
10

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:
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

11

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-), non-Luminal A breast cancer who have received treatment with an aromatase inhibitor or selective estrogen receptor modulator/downregulator (SERM/SERD) with 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">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>
11

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:
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

12

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>
12

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:
1643 miles
MD Anderson Cancer Center
Houston, TX

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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

13

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>
13

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:
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

14

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>
14

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:
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

15

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>
15

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:
1739 miles
Washington University School of Medicine
Saint 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

16

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>
16

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:
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

17

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>
17

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:
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

18

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>
18

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:
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

19

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>
19

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:
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

20

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>
20

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:
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

21

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>
21

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:
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

22

Blood Test to Identify CDK4/6 Inhibitor Levels in Blood for Women with Metastatic ER+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low</span> Breast Cancer

Use of DiviTum-TKa as a Biomarker Assay for CDK4/6 Inhibitor Medication Compliance and Drug-Drug Interaction Assessment in ER/PR Positive Metastatic Breast Cancer

Purpose: To study if the DiviTum-TKa blood test can identify and optimize levels of CDK4/6 inhibitors in the blood, help improve taking medication as prescribed, and remove potential drug-drug interactions.

Who is this for?: Women newly diagnosed 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 who are planning to receive a CDK4/6 inhibitor with hormone therapy as their first line of therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum-TKa blood tests, 1-3 times every month for up to 1 year</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A CDK4/6 inhibitor with hormone therapy is the first line of therapy for people with metastatic hormone receptor positive (HR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Thymidine kinase is a biomarker (biological molecule found in blood, other body fluids, or tissues that is a sign of a condition or disease) that reflects cell proliferation (an increase in the number of cells as a result of cell growth and cell division).</li> <li class="seamTextUnorderedListItem">DiviTum-thymidine kinase activity (TKa) is an FDA approved blood test.</li> <li class="seamTextUnorderedListItem">The DiviTum-TKa blood test shows that TKa levels are associated with a <span class="highlight">lower</span> risk of disease progression within 1-2 months of the blood test.</li> <li class="seamTextUnorderedListItem">Using the DiviTum-TKa blood test may improve taking medication as prescribed and remove potential drug-drug interactions.</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/NCT06572800' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://divitum.com/' target='_blank'>Biovica: DiviTum-TKa Information Page</a> </li></ul>
22

Blood Test to Identify CDK4/6 Inhibitor Levels in Blood for Women with Metastatic ER+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low</span> Breast Cancer

Use of DiviTum-TKa as a Biomarker Assay for CDK4/6 Inhibitor Medication Compliance and Drug-Drug Interaction Assessment in ER/PR Positive Metastatic Breast Cancer
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Nearest Location:
2582 miles
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, CT

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Visits:
1-3 visits every month for up to 1 year

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ClinicalTrials.gov: NCT06572800

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Phase NA

23

ctDNA Blood Tests to Determine an Early Switch in Treatment for Metastatic ER+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low</span> Breast Cancer

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study

Purpose: To determine whether switching treatment earlier will increase the amount of time that metastatic breast cancer is controlled.

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 who have not yet received treatment 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: No Treatment Change</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA test, monthly for 2 months, then every 2 months</li> <li class="seamTextUnorderedListItem">Standard of care: CDK4/6 inhibitor with aromatase inhibitor or CDK4/6 inhibitor with selective estrogen receptor degrader (SERD)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Switch to new treatment (if progression occurs, optional)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Early Treatment Change</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA test, monthly for 2 months, then every 2 months</li> <li class="seamTextUnorderedListItem">Standard of care: CDK4/6 inhibitor with aromatase inhibitor or CDK4/6 inhibitor with selective estrogen receptor degrader (SERD)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Early switch to a new treatment, for 1 year 2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests will be used to indicate tumor biomarkers and the presence of circulating tumor (ctDNA).</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li> <li class="seamTextUnorderedListItem">In this trial, <span class="highlight">HER2</span> <span class="highlight">low</span> is define as IHC 1+ or 2+/FISH-.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®) are types 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 premenopausal, you must also take 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/NCT05826964' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/ctdna-mbc/' target='_blank'>Metastatic Trial Talk: The Latest Research on ctDNA and MBC</a> </li></ul>
23

ctDNA Blood Tests to Determine an Early Switch in Treatment for Metastatic ER+, HER2- or <span class="highlight">HER2</span> <span class="highlight">Low</span> Breast Cancer

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study
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Nearest Location:
2591 miles
University of Miami
Miami, FL

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Visits:
At least 1 visit every 2 months

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ClinicalTrials.gov: NCT05826964

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Phase II

24

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>
24

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:
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

25

Axatilimab Immunotherapy with Targeted Therapy for Metastatic <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>
25

Axatilimab Immunotherapy with Targeted Therapy for Metastatic <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:
2693 miles
Dana-Farber Cancer Institute
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

26

Onvansertib Targeted Therapy and Chemotherapy for Advanced Triple Negative Breast Cancer

A Phase 1b/2 Study of Onvansertib in Combination With Paclitaxel in Triple-negative Metastatic Breast Cancer Patients

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of onvansertib, an experimental PLK1 inhibitor, with paclitaxel (Taxol®) chemotherapy.

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. You must not have received more than 3 lines of chemotherapy 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">Onvansertib, by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Onvansertib is an experimental targeted therapy called a PLK1 inhibitor. Blocking PLK1 slows or stops cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</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/NCT05383196' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cardiffoncology.com/onvansertib/' target='_blank'>Cardiff Oncology Drug Information Page: Onvansertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li></ul>
26

Onvansertib Targeted Therapy and Chemotherapy for Advanced Triple Negative Breast Cancer

A Phase 1b/2 Study of Onvansertib in Combination With Paclitaxel in Triple-negative Metastatic Breast Cancer Patients
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Nearest Location:
2693 miles
Dana-Farber Cancer Institute
Boston, MA

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Visits:
3 visits every month

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ClinicalTrials.gov: NCT05383196

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Phase I-II

27

Azenosertib Targeted Therapy with Chemotherapy and Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of azenosertib (ZN-C3), an experimental targeted therapy, with carboplatin (Paraplatin®) chemotherapy and pembrolizumab (Keytruda®) PD-1 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 received 1-3 lines of chemotherapy for advanced disease, including 1 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">Azenosertib (ZN-C3), by mouth, daily, 5 days on, 2 days off</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">CT or MRI scans, 4 times in 7 months, then every 3 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azenosertib (ZN-C3) is an experimental targeted therapy called a WEE1 inhibitor. Blocking WEE1 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">WEE1 is an important protein in tumor growth.</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. It is currently approved only for PD-L1 positive cancer.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug commonly used to treat breast cancer. it is considered standard of care for breast cancer.</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">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/NCT06351332' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zentalis.com/pipeline/pipeline' target='_blank'>Zentalis Pharmaceuticals: Azenosertib Drug Information Page</a> </li></ul>
27

Azenosertib Targeted Therapy with Chemotherapy and Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT)
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Nearest Location:
2693 miles
Dana-Farber Cancer Institute
Boston, MA

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Visits:
At least 1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT06351332

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Phase I-II

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