MTS Trials - BreastCancerTrials.org

1

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

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

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

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

What's involved?

You will receive an FDA-approved targeted therapy based on your tumor's genetic profile.

What's being studied?

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

How can I learn more?

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

1

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

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

Nearest Location:
2 miles
Sutter Cancer Research Consortium
San Francisco, CA

Visits:
Coincides with targeted therapy

ClinicalTrials.gov: NCT02693535

Phase II

2

BLU-222 Targeted Therapy and Hormone Therapy for Advanced ER+, HER2- Breast Cancer

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A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients With Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of BLU-222, an experimental targeted therapy, with fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer that progressed after treatment with a CDK 4/6 inhibitor. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BLU-222, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BLU-222 is an experimental targeted therapy called a CDK 2 inhibitor. It may block an enzyme, CDK 2, that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">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/NCT05252416' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.blueprintmedicines.com/pipeline/' target='_blank'>Blueprint Medicines Corporation: BLU-222 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

2

BLU-222 Targeted Therapy and Hormone Therapy for Advanced ER+, HER2- Breast Cancer

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A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients With Advanced Solid Tumors

Nearest Location:
5 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05252416

Phase I-II

3

ARV-471 Hormone Therapy for Advanced ER+, HER2- Breast Cancer

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A Phase 1, Open-label, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of ARV-471 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer, Who Have Received Prior Hormonal Therapy and Chemotherapy in the Locally...

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARV-471, an experimental hormone therapy, alone or with palbociclib (Ibrance®), a targeted therapy called a CDK 4/6 inhibitor.

Who is this for?: Postmenopausal women and men with locally advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received hormone therapy for breast cancer and chemotherapy for advanced or metastatic disease. View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471, by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help 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/NCT04072952' target='_blank'>ClinicalTrials.gov</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.breastcancer.org/treatment/targeted-therapy/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li></ul>

3

ARV-471 Hormone Therapy for Advanced ER+, HER2- Breast Cancer

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A Phase 1, Open-label, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of ARV-471 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer, Who Have Received Prior Hormonal Therapy and Chemotherapy in the Locally...

Nearest Location:
5 miles
Clinical Trial Site
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04072952

Phase I-II

4

ComboMATCH: Targeted Therapy Directed by Genetic Testing for Advanced Breast Cancer

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Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Purpose: To use genetic testing to match people to treatments and help doctors plan better treatments.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received at least 1 line of therapy for advanced disease or who have no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy based on genetic testing</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic tests look at the unique genetic material (genes) of tumor cells.</li> <li class="seamTextUnorderedListItem">People with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AKT, ERK, MEK, NF1, RAF, RAS</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/NCT05564377' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2023/combomatch-precision-medicine-cancer-initiative' target='_blank'>National Cancer Institute: ComboMATCH</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/precision-medicine-breast-cancer/about/pac-20385240' target='_blank'>Mayo Clinic: Precision Medicine for Breast Cancer</a> </li></ul>

4

ComboMATCH: Targeted Therapy Directed by Genetic Testing for Advanced Breast Cancer

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Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Nearest Location:
5 miles
UCSF Medical Center-Mission Bay
San Francisco, CA

Visits:
Please contact research site

ClinicalTrials.gov: NCT05564377

Phase II

5

ARV-471 Hormone Therapy with Abemaciclib for Advanced ER+, HER2- Breast Cancer

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

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARV-471, an experimental PROTAC protein degrader, with abemaciclib (Verzenio®) CDK 4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received treatment with a CDK 4/6 inhibitor and up to 2 lines of therapy for advanced/metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471, by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help 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/NCT05548127' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://Tactivestudy.com' target='_blank'>Pfizer: Trial Information Page</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/research-and-development/estrogen-receptor/' target='_blank'>Arvinas Estrogen Receptor: ARV-471 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>

5

ARV-471 Hormone Therapy with Abemaciclib for Advanced ER+, HER2- Breast Cancer

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

Nearest Location:
5 miles
UCSF Medical Center at Mission Bay
San Francisco, CA

Visits:
1 visit every month

ClinicalTrials.gov: NCT05548127

Phase I-II

6

Elacestrant Hormone Therapy with Anti-Cancer Therapies for Metastatic ER+, HER2- Breast Cancer

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A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of elacestrant (Orserdu®) hormone therapy in combination with other anti-cancer therapies.

Who is this for?: People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not received treatment with chemotherapy or elacestrant (Orserdu®) for advanced/metastatic disease. View full eligibility criteria

What's involved?

You will be assigned to 1 of 4 groups based on your situation: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), daily, 3 weeks on, 1 week off</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Physician's choice of palbociclib (Ibrance®), abemaciclib (Verzenio®), or ribociclib (Kisqali®), daily, 3 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</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 a mTOR inhibitor. mTOR inhibitors work by interfering with the ability of cancer cells to divide and grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called CDK 4/6 inhibitors. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help 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/NCT05563220' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/orserdu' target='_blank'>Breastcancer.org: Elacestrant (Orserdu®)</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/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors</a> </li></ul>

6

Elacestrant Hormone Therapy with Anti-Cancer Therapies for Metastatic ER+, HER2- Breast Cancer

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A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

Nearest Location:
5 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05563220

Phase I-II

7

OP-1250 Hormone Therapy with Targeted Therapy for Advanced HR+, HER2- Breast Cancer

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A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination With the CDK4/6 Inhibitor Ribociclib or With the PI3K Inhibitor Alpelisib in Adult Subjects With Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of OP-1250, an experimental hormone therapy, with ribociclib (Kisqali®) CDK 4/6 inhibitor or alpelisib (Piqray®) PI3K inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received 1-2 hormone therapies for advanced or metastatic disease. You must not have received more than 1 chemotherapy for advanced or metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®)</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250 is an experimental hormone therapy called a selective estrogen receptor downregulator (SERD) and complete estrogen receptor antagonist (CERAN). SERDs bind to and break down estrogen receptors, and CERANs block estrogen receptors.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer 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></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/NCT05508906' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://olema.com/science/' target='_blank'>Olema Oncology Drug Information Page: OP-1250</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>

7

OP-1250 Hormone Therapy with Targeted Therapy for Advanced HR+, HER2- Breast Cancer

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A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination With the CDK4/6 Inhibitor Ribociclib or With the PI3K Inhibitor Alpelisib in Adult Subjects With Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer

Nearest Location:
5 miles
University of California San Francisco Health
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05508906

Phase I

8

Experimental Anti-Estrogen Therapy Alone or with Targeted Therapy or Chemotherapy for Women with Advanced ER+, HER2- Breast Cancer

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A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS- BREAST CANCER)

Purpose: To study the anti-cancer activity and safety of giving the experimental anti-estrogen therapy giredestrant alone or with a CDK 4/6 inhibitor, an AKT inhibitor, a PI3K inhibitor, or chemotherapy.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer whose disease progressed while taking anti-hormone therapy with a CDK 4/6 inhibitor and who have not received chemotherapy for metastatic disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 6 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Ipatasertib, by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily, ongoing</li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant is an experimental anti-estrogen therapy you take by mouth. It is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degrader).</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors. The only SERD currently approved to treat breast cancer is fulvestrant (Faslodex®). Faslodex is given by injection. </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is also a CDK 4/6 inhibitor. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Ipatasertib is an experimental type of targeted therapy called an AKT inhibitor. It may slow or stop cancer cells from growing by blocking the enzyme (protein) AKT. </li> <li class="seamTextUnorderedListItem">Inavolisib is an experimental type of targeted therapy called a PI3K inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, allowing cancer cells to grow. Inavolisib may slow or stop cancer cells from growing by blocking this pathway. </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></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/NCT04802759' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html' target='_blank'>Genentech Drug Information Page: Giredestrant (GDC-9545)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors (Abemaciclib & Ribociclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/ipatasertib.html' target='_blank'>Genentech Drug Information Page: Ipatasertib (AKT Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/inavolisib.html' target='_blank'>Genentech Drug Information Page: Inavolisib (P13K Alpha Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/everolimus.aspx' target='_blank'>Chemocare: Everolimus (Afinitor)</a> </li></ul>

8

Experimental Anti-Estrogen Therapy Alone or with Targeted Therapy or Chemotherapy for Women with Advanced ER+, HER2- Breast Cancer

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A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS- BREAST CANCER)

Nearest Location:
5 miles
University of California, San Francisco (UCSF)
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04802759

Phase I-II

9

ARV-471 Hormone Therapy with Ribociclib for Advanced ER+, HER2- Breast Cancer

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

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARV-471, an experimental PROTAC protein degrader, with ribociclib (Kisqali®) CDK 4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received treatment with a CDK 4/6 inhibitor and up to 2 lines of therapy for advanced/metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471, by mouth, daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help 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/NCT05573555' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://Tactivestudy.com' target='_blank'>Pfizer: Trial Information Page</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/research-and-development/estrogen-receptor/' target='_blank'>Arvinas Estrogen Receptor: ARV-471 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li></ul>

9

ARV-471 Hormone Therapy with Ribociclib for Advanced ER+, HER2- Breast Cancer

Show Scientific Title

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

Nearest Location:
5 miles
UCSF Medical Center at Mission Bay
San Francisco, CA

Visits:
1 visit every month

ClinicalTrials.gov: NCT05573555

Phase I-II

10

LOXO-783 Targeted Therapy for Advanced Breast Cancer with a PIK3CA Mutation

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A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of LOXO-783, an experimental targeted therapy called a PI3Kα inhibitor, alone or with hormone therapy, targeted therapy, and/or chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) cancer (including breast cancer) with a PIK3CA mutation who have received up to 5 lines of treatment. If your cancer is estrogen receptor positive (ER+), you must be postmenopausal. View full eligibility criteria

What's involved?

You will be assigned to 1 of 6 groups based on when you enroll: Group 1: LOXO-783 Alone at Different Doses <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> </ul> Group 2: LOXO-783 with Hormone Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection or imlunestrant, by mouth</li> </ul> Group 3: LOXO-783 with Targeted Therapy and Hormone Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li> <li class="seamTextUnorderedListItem">Physician's choice of aromatase inhibitor, by mouth or fulvestrant (Faslodex®), by injection or imlunestrant, by mouth</li> </ul> Group 4: LOXO-783 with Hormone Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Group 5: LOXO-783 with Chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> </ul> Group 6: LOXO-783 Alone <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783 is an experimental targeted therapy called a PI3Kα inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated which allows cancer cells to grow. LOXO-783 may block the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) and imlunestrant are hormone therapies called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is approved, and imlunestrant is experimental.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, you will receive anastrozole (Arimidex®), exemestane (Aromasin®), or letrozole (Femara®).</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are hormone therapies that block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</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/NCT05307705' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.loxooncology.com/pipeline' target='_blank'>Loxo Oncology/ Eli Lilly Drug Information Page: LOXO-783 and Imlunestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://finance.yahoo.com/news/loxo-oncology-lilly-announces-details-130000189.html' target='_blank'>Eli Lilly Press Release: LOXO-783</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.newswire.ca/news-releases/lilly-announces-new-clinical-data-from-verzenio-and-oral-serd-programs-at-the-american-society-of-clinical-oncology-annual-meeting-859069920.html' target='_blank'>Eli Lilly Press Release: Imlunestrant</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/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li></ul>

10

LOXO-783 Targeted Therapy for Advanced Breast Cancer with a PIK3CA Mutation

Show Scientific Title

A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

Nearest Location:
5 miles
UCSF
San Francisco, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05307705

Phase I

11

Gedatolisib pan-PI3K/mTOR Inhibitor for Advanced HR+, HER2- Breast Cancer

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Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of gedatolisib, an experimental pan-PI3K and mTOR inhibitor, with fulvestrant (Faslodex®) hormone therapy, with or without palbociclib (Ibrance®) CDK 4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with or without a PIK3CA mutation who have received treatment with a CDK 4/6 inhibitor with an aromatase inhibitor. You must not have received more than 1 chemotherapy for advanced disease or 2 lines of hormone therapy. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 4 groups depending on your cancer: Group 1: Experimental, with or without PIK3CA Mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> Group 2: Experimental, with or without PIK3CA Mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> Group 3: Standard of Care, without PIK3CA Mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> Group 4: Standard of Care, with PIK3CA Mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib is an experimental targeted therapy called a pan-PI3K/mTOR inhibitor. Blocking PI3K and mTOR may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">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">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</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/NCT05501886' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celcuity.com/gedatolisib/' target='_blank'>Celcuity Drug Information Page: Gedatolisib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</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/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>

11

Gedatolisib pan-PI3K/mTOR Inhibitor for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

Nearest Location:
26 miles
Kaiser Permanente Medical Center - Vallejo
Vallejo, CA

Visits:
1-3 visits per month

ClinicalTrials.gov: NCT05501886

Phase III

12

Lasofoxifene Hormone Therapy with CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer With an ESR1 Mutation

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An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINEIII)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of lasofoxifene, an experimental hormone therapy, with abemaciclib (Verzenio®) CDK4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with an ESR1 mutation. You must have received an aromatase inhibitor with palbociclib (Ibrance®) or ribociclib (Kisqali®) CDK4/6 inhibitor as your first line of hormone therapy for advanced disease. You must not have received more than 1 line of chemotherapy for advanced disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lasofoxifene, by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 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">Lasofoxifene is an experimental hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. It blocks two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</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/NCT05696626' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://sermonixpharma.com/lasofoxifene/' target='_blank'>Sermonix Pharmaceuticals: Lasofoxifene Drug Information Page</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.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

12

Lasofoxifene Hormone Therapy with CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer With an ESR1 Mutation

Show Scientific Title

An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINEIII)

Nearest Location:
51 miles
Providence Medical Foundation - Santa Rosa, CA
Santa Rosa, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05696626

Phase III

13

Giredestrant Hormone Therapy with a CDK Inhibitor for Advanced ER+, HER2- Breast Cancer

Show Scientific Title

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of giredestrant, an experimental hormone therapy, compared with fulvestrant (Faslodex®) hormone therapy in combination with a CDK4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who not have received treatment (except for surgery or radiation) for advanced disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily</li> <li class="seamTextUnorderedListItem">CDK inhibitor, by mouth, daily</li> <li class="seamTextUnorderedListItem">FoundationOne Liquid CDx Assay blood test</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> <li class="seamTextUnorderedListItem">CDK inhibitor, by mouth, daily</li> <li class="seamTextUnorderedListItem">FoundationOne Liquid CDx Assay blood test</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) and giredestrant are a type of hormone therapy called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Giredestrant is an experimental SERD.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called CDK 4/6 inhibitors. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">The FoundationOne Liquid CDx Assay blood test will identify ctDNA mutations.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find 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/NCT06065748' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html#:~:text=This%20compound%20and%20its%20use,US%20Food%20and%20Drug%20Administration.' target='_blank'>Genentech: Giredestrant Drug Information Page</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/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li></ul>

13

Giredestrant Hormone Therapy with a CDK Inhibitor for Advanced ER+, HER2- Breast Cancer

Show Scientific Title

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

Nearest Location:
315 miles
Asante Rogue Regional Medical Center
Medford, OR

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06065748

Phase III

14

PF-07220060/PF-07104091 With Hormone Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

A PHASE 1B/2, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07220060 IN COMBINATION WITH PF-07104091 PLUS ENDOCRINE THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

Purpose: To study the safety, best dose, side effects, and anti-cancer activity of PF-07220060/PF-07104091, a combination of experimental targeted therapies called CDK inhibitors, with hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that has progressed on at least 1 line of therapy. View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060/PF-07104091, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060/PF-07104091, by mouth</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060 is an experimental targeted therapy called a CDK 4 inhibitor.</li> <li class="seamTextUnorderedListItem">PF-07104091 is an experimental targeted therapy called a CDK 2 inhibitor.</li> <li class="seamTextUnorderedListItem">CDK 2 and 4 are proteins that help cancer grow. Blocking CDK 2 and 4 helps slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">PF-07220060/PF-07104091 is a combination of PF-07220060 and PF-07104091.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is approved to treat hormone-positive breast cancer. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05262400' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cdn.pfizer.com/pfizercom/product-pipeline/Pipeline_Update_04MAY2021.pdf?VersionId=.06Q_HtLdkBW8lme0Y3EXpraBpgGspyg' target='_blank'>Pfizer Drug Information Page: PF-07220060 and PF-07104091</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct05262400-breast-cancer-trial' target='_blank'>Pfizer Trial Information Page: PF-07220060 and PF-07104091</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/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li></ul>

14

PF-07220060/PF-07104091 With Hormone Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

A PHASE 1B/2, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07220060 IN COMBINATION WITH PF-07104091 PLUS ENDOCRINE THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

Nearest Location:
338 miles
UCLA Hematology/Oncology
Los Angeles, CA

Visits:
At least 1 visit per month

ClinicalTrials.gov: NCT05262400

Phase I-II

15

Targeted Therapy for HER2 Positive Stage II-IV Breast Cancer

Show Scientific Title

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

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

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

What's involved?

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

What's being studied?

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

How can I learn more?

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

15

Targeted Therapy for HER2 Positive Stage II-IV Breast Cancer

Show Scientific Title

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

Nearest Location:
338 miles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, CA

Visits:
1 visit every week

ClinicalTrials.gov: NCT05319873

Phase I-II

16

Elacestrant Hormone Therapy and Abemaciclib CDK 4/6 Inhibitor for ER+, HER2- Breast Cancer with Brain Metastasis

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An Open-label Multicenter Phase 1b-2 Study of Elacestrant as Monotherapy and in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of elacestrant, an experimental hormone therapy, alone or with abemaciclib (Verzenio®) CDK 4/6 inhibitor.

Who is this for?: People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer that has spread to the brain (brain metastasis) who have received at least 1 hormone therapy, up to 2 chemotherapies, and up to 2 CDK 4/6 inhibitors for metastatic disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®)</li> <li class="seamTextUnorderedListItem">Elacestrant, daily</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). 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. CDK 4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low 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/NCT05386108' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/benefit-of-elacestrant-improves-with-longer-duration-of-cdk4-6-inhibition-in-patients-with-er-her2-metastatic-breast-cancer' target='_blank'>OncLive: Benefit of Elacestrant Improves With Longer Duration of CDK4/6 Inhibition in People With ER+/HER2- Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/the-emerald-trial-elacestrant-mechanism-of-action-study-design-and-outcomes' target='_blank'>Targeted Oncology: Elacestrant for ER+, HER2- MBC</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://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Update on Oral SERDs for Estrogen Receptor-Positive MBC</a> </li></ul>

16

Elacestrant Hormone Therapy and Abemaciclib CDK 4/6 Inhibitor for ER+, HER2- Breast Cancer with Brain Metastasis

Show Scientific Title

An Open-label Multicenter Phase 1b-2 Study of Elacestrant as Monotherapy and in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer

Nearest Location:
343 miles
California Research Institute
Los Angeles, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05386108

Phase I-II

17

ZEN003694 and Abemaciclib Targeted Therapies for Advanced Breast Cancer

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A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4/6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ZEN003694, an experimental BET bromodomain Inhibitor, with abemaciclib (Verzenio®) CDK4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN003694, by mouth, daily, 5 days on, 2 days off</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN003694 is an experimental targeted therapy called a BET bromodomain inhibitor. It may prevent the growth of tumor cells that overproduce BET protein.</li> <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">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/NCT05372640' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zenithepigenetics.com/programs/pipeline' target='_blank'>Zenith Epigenetics Drug Information Page: ZEN-3694</a> </li></ul>

17

ZEN003694 and Abemaciclib Targeted Therapies for Advanced Breast Cancer

Show Scientific Title

A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4/6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors

Nearest Location:
345 miles
Keck Medicine of USC Koreatown
Los Angeles, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05372640

Phase I

18

INCB123667 Targeted Therapy for Advanced Breast Cancer

Show Scientific Title

A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of INCB123667, an experimental type of targeted therapy called a CDK 2 inhibitor.

Who is this for?: For people with advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on standard treatment. If you have hormone receptor positive (ER+ and/or PR+) breast cancer, you must not have received treatment with a CDK 4/6 inhibitor. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INCB0123667, by mouth, daily</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require at least 1 biopsy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INCB123667 is an experimental type of targeted therapy called a CDK 2/CDK2 inhibitor.</li> <li class="seamTextUnorderedListItem">CDK 2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</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/NCT05238922' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.incyteclinicaltrials.com/study/?id=INCB%20123667-101' target='_blank'>Incyte Corporation Clinical Trial Page: INCB123667</a> </li><li class='seamTextUnorderedListItem'><a href='https://investor.incyte.com/news-releases/news-release-details/incyte-reports-2022-first-quarter-financial-results-and-provides' target='_blank'>Incyte Corporation Press Release: INCB123667</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: CDK Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors</a> </li></ul>

18

INCB123667 Targeted Therapy for Advanced Breast Cancer

Show Scientific Title

A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors

Nearest Location:
355 miles
City of Hope Medical Center
Duarte, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05238922

Phase I

19

Femara, Palbociclib, & Pembrolizumab for Metastatic ER Positive, HER2 Negative Breast Cancer

Show Scientific Title

Phase II Study of the Addition of MK-3475 (Pembrolizumab) to Letrozole and Palbociclib in Patients With Metastatic Estrogen Receptor Positive Breast Cancer Who Have Stable Disease But Are Not Responding to Letrozole and Palbociclib

Purpose: To study the anti-cancer activity and effects (good and bad) of adding the immunotherapy drug pembrolizumab (Keytruda®) to the commonly used combination of the anti-estrogen drug letrozole (Femara®) and the CDK 4/6 inhibitor palbociclib (Ibrance®).

Who is this for?: Women with metastatic (stage IV) estrogen receptor positive (ER+) HER2 negative (HER2-) breast cancer who have not yet started treatment. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) and palbociclib (Ibrance®) are an already approved therapy combination. </li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is an anti-estrogen therapy. </li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a CDK 4/6 inhibitor, which is a type of targeted therapy. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein PD-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/NCT02778685' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Palbociclib' target='_blank'>Wikipedia: Palbociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ibrance.com' target='_blank'>Pfizer Oncology Drug Information Page: Ibrance® (Palbociclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwycfkBRAFEiwAnLX5IZ2WUInCzwQ56GHMYYq-KXijoX1dzOK1O8HBbmaxajT0CPi2CbX3sRoC3A4QA' target='_blank'>Merck Oncology Drug Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/the-evolving-field-of-erpositive-metastatic-breast-cancer-care' target='_blank'>Cure Today: The Evolving Field of ER Positive-Metastatic BC</a> </li></ul>

19

Femara, Palbociclib, & Pembrolizumab for Metastatic ER Positive, HER2 Negative Breast Cancer

Show Scientific Title

Phase II Study of the Addition of MK-3475 (Pembrolizumab) to Letrozole and Palbociclib in Patients With Metastatic Estrogen Receptor Positive Breast Cancer Who Have Stable Disease But Are Not Responding to Letrozole and Palbociclib

Nearest Location:
355 miles
City of Hope Medical Center
Duarte, CA

Visits:
Every 3 weeks, ongoing

ClinicalTrials.gov: NCT02778685

Phase II

20

Effects of Abemaciclib in People 70 or Older With Metastatic Hormone Positive Breast Cancer

Show Scientific Title

A Phase IIA Trial Assessing the Tolerability of Abemaciclib Monotherapy in Patients Age 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer

Purpose: To study the side effects (good and bad) of abemaciclib (Verzenio®).

Who is this for?: People with metastatic (stage IV), hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who are age 70 or older and have already received treatment for metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a CDK 4/6 inhibitor that is commonly used to treat metastatic, hormone positive (ER+ and/or PR+) breast cancer.</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/NCT04305834' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com' target='_blank'>Drug Company Information Page: Verzenio® (Abemaciclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/blog/breast-cancer-elderly-how-bcrf-researchers-are-treating-growing-patient-population' target='_blank'>Breast Cancer Research Foundation: Breast Cancer in the Elderly</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6249663/' target='_blank'>Journal Article: Use of Cyclin-Dependent Kinase 4/6 (CDK4/6) Inhibitors in Older Patients</a> </li></ul>

20

Effects of Abemaciclib in People 70 or Older With Metastatic Hormone Positive Breast Cancer

Show Scientific Title

A Phase IIA Trial Assessing the Tolerability of Abemaciclib Monotherapy in Patients Age 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer

Nearest Location:
355 miles
City of Hope Medical Center
Duarte, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04305834

Phase II

21

Camizestrant with Targeted Therapy for Advanced HR+, HER2- Breast Cancer with an ESR1 Mutation

Show Scientific Title

A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromata...

Purpose: To compare the safety and effects (good and bad) of camizestrant (AZD9833) and a CDK4/6 inhibitor with an aromatase inhibitor and a CDK4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer and an ESR1 mutation. You must not have received treatment with fulvestrant (Faslodex®) or any investigational selective estrogen receptor degrader (SERD). View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 6 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily</li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> </ul> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833) is an experimental type of anti-estrogen therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) and abemaciclib (Verzenio®) are CDK4/6 inhibitors, a type of targeted therapy.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) and anastrozole (Arimidex®) are aromatase inhibitors, a type of hormone therapy.</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</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/NCT04964934' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/hormone-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: Hormone Therapy for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/cdk4-6-inhibitors/' target='_blank'>Susan G. Komen: CDK4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/hormone-therapy/aromatase-inhibitors/' target='_blank'>Susan G. Komen: Aromatase Inhibitors</a> </li></ul>

21

Camizestrant with Targeted Therapy for Advanced HR+, HER2- Breast Cancer with an ESR1 Mutation

Show Scientific Title

A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromata...

Nearest Location:
364 miles
Research Site
Long Beach, CA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04964934

Phase III

22

Hormone Therapy and Targeted Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

Phase II, Open-Labeled, Single-Armed Combination Treatment With Anastrozole, Fulvestrant and Abemaciclib for Hormone Receptor Positive, HER2(-) Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of fulvestrant (Faslodex®) and anastrozole (Arimidex®) hormone therapies with abemaciclib (Verzenio®) CDK 4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that progressed at least 1 year after finishing standard treatment. You must not have received treatment with fulvestrant (Faslodex®) or a CDK 4/6 inhibitor. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal 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/NCT05524584' 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/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>

22

Hormone Therapy and Targeted Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

Phase II, Open-Labeled, Single-Armed Combination Treatment With Anastrozole, Fulvestrant and Abemaciclib for Hormone Receptor Positive, HER2(-) Metastatic Breast Cancer

Nearest Location:
376 miles
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, CA

Visits:
2 visits in 1 month, then monthly

ClinicalTrials.gov: NCT05524584

Phase II

23

Vepdegestrant Hormone Therapy with PF-07220060 CDK4 Inhibitor for Advanced ER+ or ER Low, HER2- Breast Cancer

Show Scientific Title

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 low, HER2 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?

You will receive the following: <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>

23

Vepdegestrant Hormone Therapy with PF-07220060 CDK4 Inhibitor for Advanced ER+ or ER Low, HER2- Breast Cancer

Show Scientific Title

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

Nearest Location:
595 miles
START Mountain Region
West Valley City, UT

Visits:
1 visit every month

ClinicalTrials.gov: NCT06206837

Phase I-II

24

Ribociclib and Belinostat for Advanced Triple Negative Breast Cancer

Show Scientific Title

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE)

Purpose: To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor ribociclib (Kisqali®) in combination with the chemotherapy belinostat (Beleodaq®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received a CDK 4/6 inhibitor. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®), by IV, 5 days in a row (1 week on, 3 weeks off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor--it blocks two enzymes, CDK4 and CDK6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Ribociclib is approved for use in combination with an aromatase inhibitor to treat postmenopausal women with advanced hormone positive, HER2 negative breast cancer--but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®) is a type of chemotherapy called an histone deacetylase (HDAC) inhibitor. It is approved for use in some other types of cancer, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04315233' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/belinostat.aspx' target='_blank'>Chemocare.com: Belinostat (Beleodaq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617008.html' target='_blank'>MedLinePlus: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/cdk4-6-inhibitors-make-headway-in-her2-and-triple-negative-breast-cancers' target='_blank'>OncLive: CDK4/6 Inhibitors Make Headway in HER2+ and Triple-Negative Breast Cancers</a> </li></ul>

24

Ribociclib and Belinostat for Advanced Triple Negative Breast Cancer

Show Scientific Title

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE)

Nearest Location:
602 miles
Huntsman Cancer Institute
Salt Lake City, UT

Visits:
5 visits a month, ongoing

ClinicalTrials.gov: NCT04315233

Phase I

25

Samuraciclib CDK7 Inhibitor with Elacestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 and ESR1 Mutations

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A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of elacestrant (Orserdu®) 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+), HER2 negative (HER2-) breast cancer with TP53 and ESR1 mutations who are receiving or most recently received an aromatase inhibitor with a CDK4/6 inhibitor. You must not have received more than 1 line of hormone therapy for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Samuraciclib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <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> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">If you are premenopausal or perimenopausal, you will also receive a drug that will put you in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TP53, ESR1</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/NCT05963997' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.carricktherapeutics.com/pipeline/cdk7-inhibitor' target='_blank'>Carrick Therapeutics: Samuraciclib Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/orserdu' target='_blank'>Breastcancer.org: Elacestrant (Orserdu®)</a> </li></ul>

25

Samuraciclib CDK7 Inhibitor with Elacestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 and ESR1 Mutations

Show Scientific Title

A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer

Nearest Location:
679 miles
Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus
Seattle, WA

Visits:
1-2 visits every month

ClinicalTrials.gov: NCT05963997

Phase I-II

26

Elacestrant Hormone Therapy and Abemaciclib CDK 4/6 Inhibitor for Metastatic HR+, HER2- Breast Cancer with Brain or Leptomeningeal Metastasis

Show Scientific Title

Multicenter Open Label Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of elacestrant, an experimental hormone therapy, with abemaciclib (Verzenio®) CDK 4/6 inhibitor.

Who is this for?: Postmenopausal women with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer that has spread to the brain or leptomeninges (brain or leptomeningeal metastasis) who have received up to 2 chemotherapies for advanced/metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Elacestrant, by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). 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. CDK 4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low 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/NCT04791384' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/benefit-of-elacestrant-improves-with-longer-duration-of-cdk4-6-inhibition-in-patients-with-er-her2-metastatic-breast-cancer' target='_blank'>OncLive: Benefit of Elacestrant Improves With Longer Duration of CDK4/6 Inhibition in People With ER+/HER2- Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/the-emerald-trial-elacestrant-mechanism-of-action-study-design-and-outcomes' target='_blank'>Targeted Oncology: Elacestrant for ER+, HER2- MBC</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://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Update on Oral SERDs for Estrogen Receptor-Positive MBC</a> </li></ul>

26

Elacestrant Hormone Therapy and Abemaciclib CDK 4/6 Inhibitor for Metastatic HR+, HER2- Breast Cancer with Brain or Leptomeningeal Metastasis

Show Scientific Title

Multicenter Open Label Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer

Nearest Location:
732 miles
Cancer Care Northwest
Spokane Valley, WA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04791384

Phase I-II

27

PF-07220060 CDK4 Inhibitor with Fulvestrant Hormone Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received a CDK4/6 inhibitor with hormone therapy as the most recent line of therapy. You must not have received chemotherapy for advanced disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> or <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) and exemestane (Aromasin®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <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> <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">Everolimus (Afinitor®) is a type of targeted therapy called a mTOR inhibitor. mTOR inhibitors work by interfering with the ability of cancer cells to divide and grow.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen 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/NCT06105632' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct06105632-advanced-or-metastatic-breast-cancer-trial' target='_blank'>Pfizer: Trial 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>

27

PF-07220060 CDK4 Inhibitor with Fulvestrant Hormone Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY

Nearest Location:
900 miles
St. Vincent Frontier Cancer Center
Billings, MT

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06105632

Phase III

28

BGB-43395 CDK4 Inhibitor Alone or with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of BGB-43395, an experimental CDK4 inhibitor, alone or with fulvestrant (Faslodex®) or letrozole (Femara®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received hormone therapy and a CDK4/6 inhibitor. You must not have received more than 2 lines of chemotherapy for advanced disease. View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-43395, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-43395, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection or letrozole (Femara®), by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-43395 is an experimental targeted therapy called a CDK4 inhibitor. It may block the enzymes CDK4 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Premenopausal women 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/NCT06120283' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-resistance/?utm_medium=email&utm_source=subscribers&utm_campaign=Jan2024&utm_content=Email012024' target='_blank'>Metastatic Trial Talk: Overcoming Resistance to CDK4/6 Inhibitors</a> </li></ul>

28

BGB-43395 CDK4 Inhibitor Alone or with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Nearest Location:
945 miles
Sarah Cannon Research Institute (Scri) At Health One
Denver, CO

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06120283

Phase I

29

Vepdegestrant Hormone Therapy with Samuraciclib CDK7 Inhibitor for Advanced ER+ or ER Low, HER2- Breast Cancer

Show Scientific Title

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 low, HER2 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?

You will receive the following: <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>

29

Vepdegestrant Hormone Therapy with Samuraciclib CDK7 Inhibitor for Advanced ER+ or ER Low, HER2- Breast Cancer

Show Scientific Title

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...

Nearest Location:
946 miles
UCHealth - Medical Center of the Rockies
Loveland, CO

Visits:
1 visit every month

ClinicalTrials.gov: NCT06125522

Phase I-II

30

ARTS-021 CDK2 Inhibitor for Advanced HR+, HER2- or HER2 Low Breast Cancer

Show Scientific Title

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease. View full eligibility criteria

What's involved?

You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) or letrozole (Femara®)</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05867251' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://avenzotx.com/pipeline-and-science/' target='_blank'>Avenzo Therapeutics: ARTS-021 Drug and Trial Information Page</a> </li></ul>

30

ARTS-021 CDK2 Inhibitor for Advanced HR+, HER2- or HER2 Low Breast Cancer

Show Scientific Title

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

Nearest Location:
1389 miles
Oklahoma University
Oklahoma City, OK

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05867251

Phase I-II

31

Samuraciclib CDK7 Inhibitor with Fulvestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 Mutations

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An Open-label, Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant With or Without Samuraciclib in Participants With Metastatic or Locally Advanced Hormone Receptor (HR) Positive and Human Epidermal Growth Factor Receptor (HER)2-Negative Breast Cancer (BC)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of fulvestrant (Faslodex®) hormone therapy with or without samuraciclib, an experimental CDK7 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with TP53 mutations who are receiving or most recently received an aromatase inhibitor with a CDK4/6 inhibitor. You must not have received more than 1 line of hormone therapy for advanced disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times within 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Samuraciclib, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times within 1 month, then monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <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> <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">If you are premenopausal or perimenopausal, you will also receive a drug that will put you in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TP53</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/NCT05963984' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.carricktherapeutics.com/pipeline/cdk7-inhibitor' target='_blank'>Carrick Therapeutics: Samuraciclib Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

31

Samuraciclib CDK7 Inhibitor with Fulvestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 Mutations

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An Open-label, Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant With or Without Samuraciclib in Participants With Metastatic or Locally Advanced Hormone Receptor (HR) Positive and Human Epidermal Growth Factor Receptor (HER)2-Negative Breast Cancer (BC)

Nearest Location:
1504 miles
Saint Luke's Cancer Institute
Kansas City, MO

Visits:
1-2 visits every month

ClinicalTrials.gov: NCT05963984

Phase II

32

PF-07104091 for Advanced, HER2 Negative Breast Cancer

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PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY

Purpose: To study the safety, dose, side effects and anti-cancer activity of giving the experimental targeted therapy PF-07104091 alone, in combination with palbociclib (Ibrance®), or in combination with palbociclib and letrozole.

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

What's involved?

You will be assigned to 1 of 3 groups and receive the following: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07104091, by mouth, ongoing </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07104091, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07104091, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Letrozole, by mouth, daily, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07104091 is a type of targeted therapy called a CDK2 inhibitor. </li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a CDK 4/6 inhibitor. It is approved for metastatic hormone positive, HER2 negative breast cancer in combination with an anti-estrogen therapy, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat metastatic and early-stage hormone-sensitive breast cancer, but its use in this trial is considered experimental. </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/NCT04553133' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct04553133' target='_blank'>Pfizer Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors for Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6299331/' target='_blank'>Journal Article: CDK4/6 Inhibitors in Breast Cancer: Beyond Hormone Receptor-Positive HER2-Negative Disease</a> </li></ul>

32

PF-07104091 for Advanced, HER2 Negative Breast Cancer

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PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY

Nearest Location:
1539 miles
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Clive, IA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04553133

Phase I-II

33

Imlunestrant for Advanced ER+, HER2- Breast Cancer

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EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy

Purpose: To compare the effects (good and bad) and anti-cancer activity of imlunestrant, a selective estrogen receptor degrader (SERD), given alone or with abemaciclib (Verzenio®), to endocrine therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who experienced disease progression while taking an aromatase inhibitor. View full eligibility criteria

What's involved?

You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356), by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Endocrine therapy (exemestane/Aromasin®, by mouth or fulvestrant/Faslodex®, by injection)</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356), by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356) is an experimental anti-estrogen therapy called a SERD (selective estrogen receptor degrader).</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®) and fulvestrant (Faslodex®) are hormone therapies approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor that is commonly used to treat metastatic, hormone positive (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help 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/NCT04975308' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Oral SERDs for Estrogen Receptor-Positive MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.newswire.ca/news-releases/lilly-announces-new-clinical-data-from-verzenio-and-oral-serd-programs-at-the-american-society-of-clinical-oncology-annual-meeting-859069920.html' target='_blank'>Eli Lilly Press Release: Imlunestrant (LY3484356)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromasin' target='_blank'>Breastcancer.org: Exemestane (Aromasin®)</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></ul>

33

Imlunestrant for Advanced ER+, HER2- Breast Cancer

Show Scientific Title

EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy

Nearest Location:
1627 miles
Texas Oncology - Willowbrook
Houston, TX

Visits:
1 visit every month

ClinicalTrials.gov: NCT04975308

Phase III

34

Fulvestrant With Abemaciclib for ER+ or ER Low, HER2- Metastatic Breast Cancer

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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 Low (1%-10% ER), HER2 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?

You will be randomly assigned to 1 of 2 groups: Group 1 <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> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month</li> </ul> followed by: <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>

34

Fulvestrant With Abemaciclib for ER+ or ER Low, HER2- Metastatic Breast Cancer

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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

Nearest Location:
1644 miles
Houston Methodist Cancer Center
Houston, TX

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

ClinicalTrials.gov: NCT05305924

Phase II

35

An Experimental CDK4 Inhibitor for Advanced Hormone Positive Breast Cancer

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A PHASE 1/1B STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

Purpose: To study the safety, anti-cancer activity and other effects (good and bad) of the experimental targeted therapy PF-07220060.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+) breast cancer who have no standard of care therapies available. View full eligibility criteria

What's involved?

You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, ongoing</li> </ul> Please contact research site for treatment schedule.

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060 is an experimental type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. </li> <li class="seamTextUnorderedListItem">It blocks the CDK4 enzyme, which is a protein that helps cancers grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</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/NCT04557449' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizer.com/science/drug-product-pipeline' target='_blank'>Pfizer Oncology Drug Information Page: PF-07220060</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/CDK_inhibitor' target='_blank'>Wikipedia: CDK Inhibitor</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medscape.com/answers/1947145-155365/what-is-the-role-of-hormone-therapy-in-the-treatment-of-metastatic-breast-cancer' target='_blank'>MedScape: What is the Role of Hormone Therapy in the Treatment of Metastatic Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct04557449' target='_blank'>Pfizer Trial Information Page: PF-07220060</a> </li></ul>

35

An Experimental CDK4 Inhibitor for Advanced Hormone Positive Breast Cancer

Show Scientific Title

A PHASE 1/1B STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

Nearest Location:
1644 miles
The University of Texas MD Anderson Cancer Center
Houston, TX

Visits:
Number of visits unavailable, ongoing

ClinicalTrials.gov: NCT04557449

Phase I-II

36

AZD8421 CDK2 Inhibitor with Hormone Therapy and CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer

Show Scientific Title

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors (CYCAD-1)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of AZD8421, an experimental CDK2 inhibitor, with camizestrant, an experimental SERD, and a CDK4/6 inhibitor.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received a CDK4/6 inhibitor. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8421, by mouth</li> <li class="seamTextUnorderedListItem">Camizestrant, by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and/or palbociclib (Ibrance®), by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8421 is an experimental type of targeted therapy called a CDK2 inhibitor. CDK2 inhibitors may block the enzyme CDK2 that helps cancer grow.</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">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">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/NCT06188520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazeneca.com/our-therapy-areas/pipeline.html' target='_blank'>AstraZeneca: AZD8421 Drug Information Page</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'>American Association for Cancer Research: Camizestrant</a> </li></ul>

36

AZD8421 CDK2 Inhibitor with Hormone Therapy and CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer

Show Scientific Title

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors (CYCAD-1)

Nearest Location:
1644 miles
Research Site
Houston, TX

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT06188520

Phase I-II

37

CDK4/6 Inhibitor with Hormone Therapy for Advanced HR+, HER2-, HER2 Enriched or Basal Like Breast Cancer

Show Scientific Title

A Phase III, Multicenter, Open-label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor-positive/HER2-negative/HER2-Enriched Breast Cancer - HARMONIA Trial

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of hormone therapy with ribociclib (Kisqali®) or palbociclib (Ibrance®) CDK4/6 inhibitors.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), HER2 enriched or Basal like breast cancer. You must not have received treatment with chemotherapy for advanced disease or any CDK4/6 inhibitors. View full eligibility criteria

What's involved?

You will be assigned to 1 of 3 groups: Group 1: HER2 Enriched Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®)</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or fulvestrant (Faslodex®)</li> </ul> Group 2: HER2 Enriched Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®)</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or fulvestrant (Faslodex®)</li> </ul> Group 3: Basal Like Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) with or without tislelizumab</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) and palbociclib (Ibrance®) 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">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Tislelizumab is an experimental 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">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">The PAM50 (Prosigna®) test will determine if you have HER2 enriched or Basal like 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/NCT05207709' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</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/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.beigene.com/our-science-and-medicines/tislelizumab/' target='_blank'>Beigene: Tislelizumab Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/diagnosis/molecular-subtypes/' target='_blank'>Susan G. Komen: HER2-Enriched and Basal-Like Breast Cancer</a> </li></ul>

37

CDK4/6 Inhibitor with Hormone Therapy for Advanced HR+, HER2-, HER2 Enriched or Basal Like Breast Cancer

Show Scientific Title

A Phase III, Multicenter, Open-label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor-positive/HER2-negative/HER2-Enriched Breast Cancer - HARMONIA Trial

Nearest Location:
1835 miles
Carle Cancer Center
Urbana, IL

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05207709

Phase III

38

ARV-471 Hormone Therapy with CDK 4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer

Show Scientific Title

A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF ARV-471(PF-07850327) PLUS PALBOCICLIB VERSUS LETROZOLE PLUS PALBOCICLIB FOR THE TREATMENT OF PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI-CANCER TREATMENT FOR ADVANCED DISEASE (VERITAC-3)

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of ARV-471, an experimental hormone therapy, and letrozole (Femara®) hormone therapy with palbociclib (Ibrance®) CDK 4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not yet received treatment for advanced disease. You must not have received treatment with a CDK 4/6 inhibitor or fulvestrant (Faslodex®). View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471, by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 (vepdegestrant, PF-07850327) is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone receptor positive 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/NCT05909397' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/nct05909397-advanced-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.breastcancer.org/treatment/targeted-therapy/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li></ul>

38

ARV-471 Hormone Therapy with CDK 4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer

Show Scientific Title

A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF ARV-471(PF-07850327) PLUS PALBOCICLIB VERSUS LETROZOLE PLUS PALBOCICLIB FOR THE TREATMENT OF PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI-CANCER TREATMENT FOR ADVANCED DISEASE (VERITAC-3)

Nearest Location:
2054 miles
University of Michigan
Ann Arbor, MI

Visits:
3 visits every month

ClinicalTrials.gov: NCT05909397

Phase III

39

INX-315 CDK2 Inhibitor for Advanced ER+, HER2- or CCNE1 Amplified Breast Cancer

Show Scientific Title

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of INX-315, an experimental CDK2 inhibitor, alone or with other anti-cancer therapies.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received treatment with a CDK4/6 inhibitor or CCNE1 amplified breast cancer with no standard treatment options available. View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups based on your type of cancer: Group 1: CCNE1 Amplified Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315, by mouth</li> </ul> Group 2: ER Positive, HER2 Negative Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315, by mouth</li> <li class="seamTextUnorderedListItem">Selective estrogen receptor degrader (SERD) hormone therapy (standard of care)</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitor (standard of care)</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Selective estrogen receptor degraders (SERD) are a type of hormone therapy that bind to and break down estrogen receptors. </li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are a type of targeted therapy that block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CCNE1</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/NCT05735080' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://incyclixbio.com/our-science/' target='_blank'>Incyclix Bio Drug Information Page: INX-315</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy and SERDs</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: The Latest Research on CDK 4/6 Inhibitors</a> </li></ul>

39

INX-315 CDK2 Inhibitor for Advanced ER+, HER2- or CCNE1 Amplified Breast Cancer

Show Scientific Title

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer

Nearest Location:
2140 miles
Emory Winship Cancer Institute
Atlanta, GA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05735080

Phase I-II

40

Immunotherapy, Chemotherapy, and Targeted Therapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of pembrolizumab (Keytruda®) PD-1 inhibitor, gemcitabine (Gemzar®) and carboplatin (Paraplatin®) chemotherapy, and trilaciclib (Cosela®) CDK4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer. You must not have received more than 3 lines of chemotherapy for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®), by IV, weekly, 2 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <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">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®) also helps protect the bone marrow from the side effects of chemotherapy.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low 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/NCT06027268' target='_blank'>ClinicalTrials.gov</a> </li></ul>

40

Immunotherapy, Chemotherapy, and Targeted Therapy for Advanced Triple Negative Breast Cancer

Show Scientific Title

ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)

Nearest Location:
2300 miles
Levine Cancer Institute
Charlotte, NC

Visits:
1 visit every 1-2 weeks

ClinicalTrials.gov: NCT06027268

Phase II

41

Stereotactic Radiation, Abemaciclib, and Hormone Therapy for HR+, HER2- Breast Cancer Brain Metastases

Show Scientific Title

Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases

Purpose: To study the anti-cancer activity and side effects of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®), hormone therapy, and stereotactic radiation therapy together to treat brain metastases.

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

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Doctor's choice of anti-estrogen therapy, ongoing</li> <li class="seamTextUnorderedListItem">Stereotactic Radiation Therapy to each brain met</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. This stops cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Anti-estrogen therapies are commonly used to treat hormone receptor-positive breast cancer. These drugs are also called endocrine or hormone therapy and include tamoxifen, aromatase inhibitors, fulvestrant, and others. </li> <li class="seamTextUnorderedListItem">The hormone therapies used in this trial are fulvestrant and aromatase inhibitors.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</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/NCT04923542' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/?s=brain+mets' target='_blank'>Metastatic Trial Talk: Topics for Breast Cancer Brain Mets</a> </li></ul>

41

Stereotactic Radiation, Abemaciclib, and Hormone Therapy for HR+, HER2- Breast Cancer Brain Metastases

Show Scientific Title

Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases

Nearest Location:
2396 miles
Moffitt Cancer Center
Tampa, FL

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT04923542

Phase I-II

42

RGT-419B Targeted Therapy for HR+, HER2- Advanced Breast Cancer

Show Scientific Title

First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of RGT-419B, an experimental type of targeted therapy called a CDK 2/4/6 inhibitor, alone and with hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that has progressed after treatment with a CDK 4/6 inhibitor and hormone therapy. You must not have received more than 1 line of chemotherapy. View full eligibility criteria

What's involved?

You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT-419B, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT-419B, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT-419B is an experimental type of targeted therapy called a CDK 2/4/6 inhibitor. It is designed to block three enzymes, CDK2, CDK4, and CDK6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, you will receive one of the following types of hormone therapy that you have already received: selective estrogen receptor degrader (SERD), selective estrogen receptor modulator (SERM), or aromatase inhibitor.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05304962' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biospace.com/article/releases/regor-therapeutics-announces-u-s-fda-authorization-to-conduct-regor-s-first-in-human-clinical-trial-with-the-next-generation-targeted-inhibitor-rgt-419b-for-oncology/' target='_blank'>Regor Therapeutics Press Release: RGT-419B</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: CDK Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

42

RGT-419B Targeted Therapy for HR+, HER2- Advanced Breast Cancer

Show Scientific Title

First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer

Nearest Location:
2537 miles
Hem-Onc Associates of the Treasure Coast
Port Saint Lucie, FL

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05304962

Phase I

43

Abemaciclib With Bicalutamide for Androgen Receptor+, HER2- Advanced Breast Cancer

Show Scientific Title

A Multicenter, Phase IB/II Study of Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

Purpose: To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®) together with bicalutamide (Casodex®), an anti-androgen drug.

Who is this for?: Postmenopausal women with advanced (some stage III) or metastatic (stage IV) androgen receptor positive (AR+) HER2 negative breast cancer. You must have received at least one line of therapy for advanced disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®), by mouth, twice daily</li> </ul> Please contact research site for treatment schedule.

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®) is an anti-androgen drug used to treat prostate 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/NCT05095207' target='_blank'>ClinicalTrials.gov</a> </li></ul>

43

Abemaciclib With Bicalutamide for Androgen Receptor+, HER2- Advanced Breast Cancer

Show Scientific Title

A Multicenter, Phase IB/II Study of Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

Nearest Location:
2568 miles
Mount Sinai - West
New York, NY

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05095207

Phase I-II

44

ctDNA Blood Tests to Determine an Early Switch in Treatment for Metastatic ER+, HER2- or HER2 Low Breast Cancer

Show Scientific Title

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+), HER2 negative (HER2-) or HER2 low breast cancer who have not yet received treatment for advanced disease. View full eligibility criteria

What's involved?

You will be randomly assigned to 1 of 2 groups: Group 1: No Treatment Change <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> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Switch to new treatment (if progression occurs, optional)</li> </ul> Group 2: Early Treatment Change <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> followed by: <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, HER2 low 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>

44

ctDNA Blood Tests to Determine an Early Switch in Treatment for Metastatic ER+, HER2- or HER2 Low Breast Cancer

Show Scientific Title

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

Nearest Location:
2592 miles
University of Miami
Miami, FL

Visits:
At least 1 visit every 2 months

ClinicalTrials.gov: NCT05826964

Phase II

45

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

Show Scientific Title

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 low, HER2 negative (HER2-) or HER2 low 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?

You will be assigned to 1 of 4 groups based on biomarker testing results: Group 1 <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> Group 2 <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> Group 3 <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> Group 4 <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 HER2 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, HER2 low 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>

45

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

Show Scientific Title

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

Nearest Location:
2619 miles
Dartmouth Hitchcock Medical Center
Lebanon, NH

Visits:
1 visit every month

ClinicalTrials.gov: NCT05933395

Phase II

46

Palbociclib with TAS-116 Targeted Therapy for Advanced HR+, HER2- or RB Deficient Breast Cancer

Show Scientific Title

Phase Ib IIT of Heat Shock Protein 90 Inhibitor TAS-116 Combined With Cyclin-dependent Kinase 4/6 Inhibitor Palbociclib in Advanced Breast Cancer Progressing on Palbociclib & Treatment-refractory Solid Tumors With Retinoblastoma Deficiency

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of palbociclib (Ibrance®) CDK4/6 inhibitor with TAS-116, an experimental HSP90 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or RB deficient breast cancer who have received one line of therapy or have no standard treatment options available. You must have received palbociclib (Ibrance®). View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">TAS-116, daily, 5 days on, 2 days off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">TAS-116 is an experimental targeted therapy called a HSP90 inhibitor. Blocking HSP90 may help slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">RB deficient means there is an abnormality in a gene called the <q>retinoblastoma gene</q>.</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/NCT05655598' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.taiho.co.jp/en/science/pipeline/' target='_blank'>Taiho Pharma: TAS-116 Drug Information Page</a> </li></ul>

46

Palbociclib with TAS-116 Targeted Therapy for Advanced HR+, HER2- or RB Deficient Breast Cancer

Show Scientific Title

Phase Ib IIT of Heat Shock Protein 90 Inhibitor TAS-116 Combined With Cyclin-dependent Kinase 4/6 Inhibitor Palbociclib in Advanced Breast Cancer Progressing on Palbociclib & Treatment-refractory Solid Tumors With Retinoblastoma Deficiency

Nearest Location:
2684 miles
Lifespan Cancer Institute
Providence, RI

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05655598

Phase I

47

Targeted Therapy Palbociclib for Brain Metastases

Show Scientific Title

A Phase 2 Study of Palbociclib in Progressive Brain Metastases Harboring Alterations in the CDK Pathway

Purpose: To study the safety, anti-cancer activity, and side effects of giving the CDK 4/6 inhibitor palbociclib (Ibrance®).

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). You may not enroll if you have already received a CDK 4/6 inhibitor. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is commonly used with anti-estrogen therapy for metastatic, hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer that metastasized to the brain.</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/NCT02896335' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>

47

Targeted Therapy Palbociclib for Brain Metastases

Show Scientific Title

A Phase 2 Study of Palbociclib in Progressive Brain Metastases Harboring Alterations in the CDK Pathway

Nearest Location:
2693 miles
Massachusetts General Hospital
Boston, MA

Visits:
Please contact the research site

ClinicalTrials.gov: NCT02896335

Phase II

48

VS-6766 Targeted Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

A Single Arm Phase 1/2 Trial of Abemaciclib + VS-6766 + Fulvestrant in Metastatic HR+/HER2- Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of VS-6766, an experimental RAF/MEK inhibitor, with abemaciclib (Verzenio®) CDK 4/6 inhibitor and fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. You must have received treatment with fulvestrant (Faslodex)® for advanced/metastatic disease and a CDK 4/6 inhibitor after surgery (adjuvant) or for advanced/metastatic disease. View full eligibility criteria

What's involved?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VS-6766, by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Please contact research site for treatment schedule

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VS-6766 is an experimental targeted therapy called a RAF/MEK inhibitor that targets and interrupts a pathway that allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two proteins, CDK4 and CDK6, that help 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">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/NCT05608252' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verastem.com/research/pipeline/#raf-mek-inhibition' target='_blank'>Verastem: VS-6766 Drug Information Page</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.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

48

VS-6766 Targeted Therapy for Advanced HR+, HER2- Breast Cancer

Show Scientific Title

A Single Arm Phase 1/2 Trial of Abemaciclib + VS-6766 + Fulvestrant in Metastatic HR+/HER2- Breast Cancer

Nearest Location:
2693 miles
Dana Farber Cancer Institite
Boston, MA

Visits:
Number of visits unavailable

ClinicalTrials.gov: NCT05608252

Phase I-II

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

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

BLU-222 Targeted Therapy and Hormone Therapy for Advanced ER+, HER2- Breast Cancer

BLU-222 Targeted Therapy and Hormone Therapy for Advanced ER+, HER2- Breast Cancer

ARV-471 Hormone Therapy for Advanced ER+, HER2- Breast Cancer

ARV-471 Hormone Therapy for Advanced ER+, HER2- Breast Cancer

ComboMATCH: Targeted Therapy Directed by Genetic Testing for Advanced Breast Cancer

ComboMATCH: Targeted Therapy Directed by Genetic Testing for Advanced Breast Cancer

ARV-471 Hormone Therapy with Abemaciclib for Advanced ER+, HER2- Breast Cancer

ARV-471 Hormone Therapy with Abemaciclib for Advanced ER+, HER2- Breast Cancer

Elacestrant Hormone Therapy with Anti-Cancer Therapies for Metastatic ER+, HER2- Breast Cancer

Elacestrant Hormone Therapy with Anti-Cancer Therapies for Metastatic ER+, HER2- Breast Cancer

OP-1250 Hormone Therapy with Targeted Therapy for Advanced HR+, HER2- Breast Cancer

OP-1250 Hormone Therapy with Targeted Therapy for Advanced HR+, HER2- Breast Cancer

Experimental Anti-Estrogen Therapy Alone or with Targeted Therapy or Chemotherapy for Women with Advanced ER+, HER2- Breast Cancer

Experimental Anti-Estrogen Therapy Alone or with Targeted Therapy or Chemotherapy for Women with Advanced ER+, HER2- Breast Cancer

ARV-471 Hormone Therapy with Ribociclib for Advanced ER+, HER2- Breast Cancer

ARV-471 Hormone Therapy with Ribociclib for Advanced ER+, HER2- Breast Cancer

LOXO-783 Targeted Therapy for Advanced Breast Cancer with a PIK3CA Mutation

LOXO-783 Targeted Therapy for Advanced Breast Cancer with a PIK3CA Mutation

Gedatolisib pan-PI3K/mTOR Inhibitor for Advanced HR+, HER2- Breast Cancer

Gedatolisib pan-PI3K/mTOR Inhibitor for Advanced HR+, HER2- Breast Cancer

Lasofoxifene Hormone Therapy with CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer With an ESR1 Mutation

Lasofoxifene Hormone Therapy with CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer With an ESR1 Mutation

Giredestrant Hormone Therapy with a CDK Inhibitor for Advanced ER+, HER2- Breast Cancer

Giredestrant Hormone Therapy with a CDK Inhibitor for Advanced ER+, HER2- Breast Cancer

PF-07220060/PF-07104091 With Hormone Therapy for Advanced HR+, HER2- Breast Cancer

PF-07220060/PF-07104091 With Hormone Therapy for Advanced HR+, HER2- Breast Cancer

Targeted Therapy for HER2 Positive Stage II-IV Breast Cancer

Targeted Therapy for HER2 Positive Stage II-IV Breast Cancer

Elacestrant Hormone Therapy and Abemaciclib CDK 4/6 Inhibitor for ER+, HER2- Breast Cancer with Brain Metastasis

Elacestrant Hormone Therapy and Abemaciclib CDK 4/6 Inhibitor for ER+, HER2- Breast Cancer with Brain Metastasis

ZEN003694 and Abemaciclib Targeted Therapies for Advanced Breast Cancer

ZEN003694 and Abemaciclib Targeted Therapies for Advanced Breast Cancer

INCB123667 Targeted Therapy for Advanced Breast Cancer

INCB123667 Targeted Therapy for Advanced Breast Cancer

Femara, Palbociclib, & Pembrolizumab for Metastatic ER Positive, HER2 Negative Breast Cancer

Femara, Palbociclib, & Pembrolizumab for Metastatic ER Positive, HER2 Negative Breast Cancer

Effects of Abemaciclib in People 70 or Older With Metastatic Hormone Positive Breast Cancer

Effects of Abemaciclib in People 70 or Older With Metastatic Hormone Positive Breast Cancer

Camizestrant with Targeted Therapy for Advanced HR+, HER2- Breast Cancer with an ESR1 Mutation

Camizestrant with Targeted Therapy for Advanced HR+, HER2- Breast Cancer with an ESR1 Mutation

Hormone Therapy and Targeted Therapy for Advanced HR+, HER2- Breast Cancer

Hormone Therapy and Targeted Therapy for Advanced HR+, HER2- Breast Cancer

Vepdegestrant Hormone Therapy with PF-07220060 CDK4 Inhibitor for Advanced ER+ or ER Low, HER2- Breast Cancer

Vepdegestrant Hormone Therapy with PF-07220060 CDK4 Inhibitor for Advanced ER+ or ER Low, HER2- Breast Cancer

Ribociclib and Belinostat for Advanced Triple Negative Breast Cancer

Ribociclib and Belinostat for Advanced Triple Negative Breast Cancer

Samuraciclib CDK7 Inhibitor with Elacestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 and ESR1 Mutations

Samuraciclib CDK7 Inhibitor with Elacestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 and ESR1 Mutations

Elacestrant Hormone Therapy and Abemaciclib CDK 4/6 Inhibitor for Metastatic HR+, HER2- Breast Cancer with Brain or Leptomeningeal Metastasis

Elacestrant Hormone Therapy and Abemaciclib CDK 4/6 Inhibitor for Metastatic HR+, HER2- Breast Cancer with Brain or Leptomeningeal Metastasis

PF-07220060 CDK4 Inhibitor with Fulvestrant Hormone Therapy for Advanced HR+, HER2- Breast Cancer

PF-07220060 CDK4 Inhibitor with Fulvestrant Hormone Therapy for Advanced HR+, HER2- Breast Cancer

BGB-43395 CDK4 Inhibitor Alone or with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

BGB-43395 CDK4 Inhibitor Alone or with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

Vepdegestrant Hormone Therapy with Samuraciclib CDK7 Inhibitor for Advanced ER+ or ER Low, HER2- Breast Cancer

Vepdegestrant Hormone Therapy with Samuraciclib CDK7 Inhibitor for Advanced ER+ or ER Low, HER2- Breast Cancer

ARTS-021 CDK2 Inhibitor for Advanced HR+, HER2- or HER2 Low Breast Cancer

ARTS-021 CDK2 Inhibitor for Advanced HR+, HER2- or HER2 Low Breast Cancer

Samuraciclib CDK7 Inhibitor with Fulvestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 Mutations

Samuraciclib CDK7 Inhibitor with Fulvestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 Mutations

PF-07104091 for Advanced, HER2 Negative Breast Cancer

PF-07104091 for Advanced, HER2 Negative Breast Cancer

Imlunestrant for Advanced ER+, HER2- Breast Cancer

Imlunestrant for Advanced ER+, HER2- Breast Cancer

Fulvestrant With Abemaciclib for ER+ or ER Low, HER2- Metastatic Breast Cancer

Fulvestrant With Abemaciclib for ER+ or ER Low, HER2- Metastatic Breast Cancer

An Experimental CDK4 Inhibitor for Advanced Hormone Positive Breast Cancer

An Experimental CDK4 Inhibitor for Advanced Hormone Positive Breast Cancer

AZD8421 CDK2 Inhibitor with Hormone Therapy and CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer

AZD8421 CDK2 Inhibitor with Hormone Therapy and CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer

CDK4/6 Inhibitor with Hormone Therapy for Advanced HR+, HER2-, HER2 Enriched or Basal Like Breast Cancer

CDK4/6 Inhibitor with Hormone Therapy for Advanced HR+, HER2-, HER2 Enriched or Basal Like Breast Cancer

ARV-471 Hormone Therapy with CDK 4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer

ARV-471 Hormone Therapy with CDK 4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer

INX-315 CDK2 Inhibitor for Advanced ER+, HER2- or CCNE1 Amplified Breast Cancer