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Trials last updated: July 18, 2026

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1

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

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?

<p class="seamTextPara"> You will be randomly assigned to 1 of 6 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6</i> </p> <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 <span class="highlight">PIK3CA</span> 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>
1

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

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)
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Nearest Location from 94107:
3 miles
University of California, San Francisco (UCSF)
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04802759

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Phase I-II

2

RLY-2608 PI3Kα Inhibitor Plus Fulvestrant Versus Capivasertib AKT Inhibitor Plus Fulvestrant for Advanced <span class="highlight">PIK3CA-Mutant</span> HR+, HER2- Breast Cancer

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a <span class="highlight">PIK3CA</span> mutation whose cancer has progressed while receiving 1 or 2 lines of hormone therapy and a CDK4/6 inhibitor. You must not have received certain treatments that are listed below. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib (Truqap®), by mouth, daily, 4 days on 3 days off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li></ul>

What's being studied?

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

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06982521' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://relaytx.com/pipeline/#hero-scroll' target='_blank'>Relay Therapeutics: RLY-2608</a> </li></ul>
2

RLY-2608 PI3Kα Inhibitor Plus Fulvestrant Versus Capivasertib AKT Inhibitor Plus Fulvestrant for Advanced <span class="highlight">PIK3CA-Mutant</span> HR+, HER2- Breast Cancer

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for <span class="highlight">PIK3CA-mutant</span> Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Tr...(ReDiscover-2)
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Nearest Location from 94107:
3 miles
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, CA

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Visits:
Monthly

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ClinicalTrials.gov: NCT06982521

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Phase III

3

ETX-636 Targeted Therapy for Advanced HR+, HER2- Breast Cancer With <span class="highlight">PIK3CA</span> Mutations

A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ETX-636, an experimental targeted therapy, 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 with <span class="highlight">PIK3CA</span> mutations who have received at least 1 CDK4/6 inhibitor and hormone therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ETX-636, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ETX-636 is an experimental targeted therapy called a PI3K alpha inhibitor that blocks the growth of cancer cells with a <span class="highlight">PIK3CA</span> mutation.</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></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/NCT06993844' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ensemtx.com/science/pipeline/' target='_blank'>Ensem Therapeutics: ETX-636 Drug Information Page</a> </li></ul>
3

ETX-636 Targeted Therapy for Advanced HR+, HER2- Breast Cancer With <span class="highlight">PIK3CA</span> Mutations

A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors
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Nearest Location from 94107:
3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, CA

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Visits:
At least 1 visit every month

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ClinicalTrials.gov: NCT06993844

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Phase I-II

4

Inavolisib Targeted Therapy with CDK4/6 Inhibitor and Hormone Therapy for HR+, HER2- Advanced Breast Cancer with <span class="highlight">PIK3CA</span> Mutations

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive <span class="highlight">PIK3CA-Mutated,</span> Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of inavolisib (Itovebi®) PI3K inhibitor with palbociclib (Ibrance®) CDK4/6 inhibitor and letrozole (Femara®) aromatase 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 a <span class="highlight">PIK3CA</span> mutation. You must have been diagnosed with de novo advanced/metastatic breast cancer or received at least 2 years of hormone therapy and completed hormone therapy at least 1 year before your advanced/metastatic diagnosis. You must have not yet received treatment for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®), 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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for inavolisib (Itovebi®), 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>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®) is a type of targeted therapy called a PI3K inhibitor. It can stop cancer cell growth of tumors with a <span class="highlight">PIK3CA</span> mutation.</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">Letrozole (Femara®) 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/NCT06790693' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.itovebi.com/?c=ina-192c045e973&gad_source=1&gad_campaignid=22379686314&gclid=CjwKCAjw3_PCBhA2EiwAkH_j4vPWHwf18zpyVOBvHcRP6iHfngpGw_isqNXvAvPlr2i6vJ0TAA8mdxoCtHYQAvD_BwE&gclsrc=aw.ds' target='_blank'>Hoffman-La Roche: Inavolisib (Itovebi®)</a> </li></ul>
4

Inavolisib Targeted Therapy with CDK4/6 Inhibitor and Hormone Therapy for HR+, HER2- Advanced Breast Cancer with <span class="highlight">PIK3CA</span> Mutations

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive <span class="highlight">PIK3CA-Mutated,</span> Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123)
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Nearest Location from 94107:
14 miles
Palo Alto Medical Foundation Research Center
San Mateo, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06790693

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Phase III

5

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

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

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

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

What's involved?

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

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tersolisib (LY4064809) is an experimental type of targeted therapy called a PI3K inhibitor. </li> <li class="seamTextUnorderedListItem">If there is a mutation in the <span class="highlight">PIK3CA</span> gene, the PI3K pathway can become overactivated, allowing cancer cells to grow. Tersolisib may slow or stop cancer cells from growing by blocking this pathway.</li> <li class="seamTextUnorderedListItem">Standard of care treatment for hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer is treatment with hormone therapy along with a CDK inhibitor.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07174336' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/mbc-biomarkers-part-1/' target='_blank'>Metastatic Trial Talk: Biomarkers to Guide MBC Treatment Decisions: PIK3CA, BRCA1/BRCA2, and PD-L1/PD-1</a> </li></ul>
5

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

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

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

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ClinicalTrials.gov: NCT07174336

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Phase III

6

RLY-2608 Alone and With Fulvestrant for Advanced Breast Cancer with a <span class="highlight">PIK3CA</span> Mutation

A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer

Purpose: To study the safety, best dose, and effects (good and bad) of RLY-2608 alone and in combination with fulvestrant (Faslodex®).

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

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on when you enroll: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require a biopsy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608 is an experimental targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">If there is a mutation in the <span class="highlight">PIK3CA</span> gene, the PI3K pathway can become overactivated which allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">RLY-2608 may block the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy 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">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">PIK3CA</li></ul></span>

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/NCT05216432' target='_blank'>ClinicalTrials.gov</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.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ir.relaytx.com/news-releases/news-release-details/relay-therapeutics-announces-dosing-first-patient-first-human-0' target='_blank'>Relay Therapeutics Press Release: RLY-2608</a> </li></ul>
6

RLY-2608 Alone and With Fulvestrant for Advanced Breast Cancer with a <span class="highlight">PIK3CA</span> Mutation

A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer
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Nearest Location from 94107:
186 miles
Renown Regional Medical Center
Reno, NV

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05216432

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Phase I

7

Inavolisib and Phesgo for Advanced HER2 Positive Breast Cancer with a <span class="highlight">PIK3CA</span> Mutation

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

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

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

What's involved?

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

What's being studied?

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

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05894239' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/medical-professionals/pipeline/inavolisib-gdc-0077' target='_blank'>Genentech: Inavolisib Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/phesgo' target='_blank'>Breastcancer.org: Phesgo</a> </li></ul>
7

Inavolisib and Phesgo for Advanced HER2 Positive Breast Cancer with a <span class="highlight">PIK3CA</span> Mutation

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With <span class="highlight">PIK3CA-Mutated</span> HER2-Positive Locally Advanced or Metastatic Breast Cancer...
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Nearest Location from 94107:
337 miles
Disney Family Cancer Center
Burbank, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05894239

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Phase III

8

AMXT 1501 and DFMO in Combination With Standard Therapies for Advanced ER+, HER2- Breast Cancer

A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of AMXT 1501 and DFMO when combined with standard treatments.

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 alterations in the genes, <span class="highlight">PIK3CA,</span> AKT1, or PTEN, whose cancer has progressed on at least 2 hormone therapies. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AMXT 1501, by mouth, daily</li> <li class="seamTextUnorderedListItem">DFMO, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> <li class="seamTextUnorderedListItem">Capivasertib (Truqap®), by mouth, 4 days on, 3 days off</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Biopsies, 2 times within 2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AMXT 1501 and DFMO block molecules involved in tumor growth and survival. Together, they may improve tumor response to standard cancer treatments, reduce tumor growth, and reverse tumor-induced immunosuppression.</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">Capivasertib (Truqap®) is a targeted therapy for people with abnormal changes in <span class="highlight">PIK3CA,</span> AKT1, and/or PTEN genes and whose cancer has progressed on or after hormone therapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with melanoma (skin 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/NCT07287917' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://aminextx.com/science/' target='_blank'>Aminex Therapeutics: AMXT 1501 and DFMO</a> </li></ul>
8

AMXT 1501 and DFMO in Combination With Standard Therapies for Advanced ER+, HER2- Breast Cancer

A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies
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Nearest Location from 94107:
339 miles
START Los Angeles
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT07287917

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Phase I-II

9

Targeted Therapy for Advanced HR+, HER2 Negative Breast Cancer With a <span class="highlight">PIK3CA</span> Mutation

A Phase 1/1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic <span class="highlight">PIK3CA-Mutated</span> Solid Tumors Including HR+/HER2- Breast Cancers

Purpose: To study the safety, side effects (good and bad), and anti-cancer activity of a targeted therapy called RGT‑490.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor‑positive (ER+ and/or PR+), HER2‑negative breast cancer that has a <span class="highlight">PIK3CA</span> gene mutation and has progressed after at least one prior line of treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT‑490, by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT‑490 is an experimental targeted therapy called a PI3K alpha inhibitor that blocks the growth of cancer cells with a <span class="highlight">PIK3CA</span> mutation.</li> <li class="seamTextUnorderedListItem">This is a dose finding study meaning that some people will receive different doses of RGT-490 as researchers determine the safest dose.</li> <li class="seamTextUnorderedListItem">This study is also enrolling people with other cancers.</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/NCT07524322' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/pik3ca-mbc-2/' target='_blank'>Metastatic Trial Talk: New Targeted Treatment Options for Metastatic Breast Cancer: Updates on PIK3CA</a> </li></ul>
9

Targeted Therapy for Advanced HR+, HER2 Negative Breast Cancer With a <span class="highlight">PIK3CA</span> Mutation

A Phase 1/1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic <span class="highlight">PIK3CA-Mutated</span> Solid Tumors Including HR+/HER2- Breast Cancers
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Nearest Location from 94107:
339 miles
START Los Angeles
Los Angeles, CA

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Visits:
At least 1 visit every month

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ClinicalTrials.gov: NCT07524322

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Phase I

10

Inavolisib With Fulvestrant for Advanced HR+, HER2- Breast Cancer with <span class="highlight">PIK3CA</span> Mutations

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With <span class="highlight">PIK3CA-Mutated,</span> HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of inavolisib (Itovebi®) PI3K inhibitor with fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+), HER2 negative (HER2-) breast cancer with a <span class="highlight">PIK3CA</span> mutation whose disease progressed while taking anti-hormone therapy with a CDK 4/6 inhibitor. You must not have received more than 1 line of anti-hormone therapy with a CDK 4/6 inhibitors for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To find out how well inavolisib with fulvestrant works, and how safe inavolisib is at different doses. </li> <li class="seamTextUnorderedListItem">If there is a mutation in the <span class="highlight">PIK3CA</span> gene, the PI3K pathway can become overactivated which allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®) is a type of targeted therapy called a PI3K inhibitor. It can stop cancer cell growth of tumors with a <span class="highlight">PIK3CA</span> mutation.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy 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></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/NCT07368998' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healthline.com/health/metastatic-breast-cancer/pik3ca-mutation-and-breast-cancer#what-is-the-pik-3-ca-gene' target='_blank'>Healthline: PIK3CA Mutations in Breast Cancer: What Does It Mean?</a> </li></ul>
10

Inavolisib With Fulvestrant for Advanced HR+, HER2- Breast Cancer with <span class="highlight">PIK3CA</span> Mutations

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With <span class="highlight">PIK3CA-Mutated,</span> HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
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Nearest Location from 94107:
346 miles
Los Angeles Cancer Network
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT07368998

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Phase II

11

Evexomostat for Women with Advanced HR+, HER2- Breast Cancer with a <span class="highlight">PIK3CA</span> Mutation and High Blood Sugar

Phase 1b/2 Study of the Safety and Efficacy of Evexomostat Plus Alpelisib and Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia With Advanced Breast Cancer and a <span class="highlight">PIK3CA</span> Mutation Following Endocrine Therapy and a CDK4/6 Inhibitor

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of evexomostat (SDX-7320), an experimental polymer drug conjugate, with fulvestrant (Faslodex®) hormone therapy and alpelisib (Piqray®) PI3K inhibitor.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a <span class="highlight">PIK3CA</span> mutation who have high blood sugar. You must have received hormone therapy and a CDK 4/6 inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) is an experimental polymer drug conjugate (PDC), which is similar to an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) releases fumagillol, a type of targeted therapy called a MetAP2 inhibitor. Blocking MetAP2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">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: <span class="highlight">PIK3CA</li></ul></span>

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/NCT05455619' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.amelia1.com/' target='_blank'>SynDevRx: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/lead-compound-sdx-7320/' target='_blank'>SynDevRx Drug Information Page: Evexomostat (SDX-7320)</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/science/polymer-drug-conjugation/' target='_blank'>SynDevRx: Polymer Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/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

Evexomostat for Women with Advanced HR+, HER2- Breast Cancer with a <span class="highlight">PIK3CA</span> Mutation and High Blood Sugar

Phase 1b/2 Study of the Safety and Efficacy of Evexomostat Plus Alpelisib and Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia With Advanced Breast Cancer and a <span class="highlight">PIK3CA</span> Mutation Following Endocrine Therapy and a CDK4/6 Inhibitor
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Nearest Location from 94107:
381 miles
Hoag Memorial Hospital Presbyterian
Newport, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05455619

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Phase I-II

12

TOS-358 Targeted Therapy for Advanced HER2- Breast Cancer With a <span class="highlight">PIK3CA</span> Mutation

A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-Alpha Inhibitor, TOS-358, in Adult Subjects With Select Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of TOS-358, an experimental PI3K inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer with a <span class="highlight">PIK3CA</span> mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TOS-358, by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TOS-358 is an experimental targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">If there is a mutation in the <span class="highlight">PIK3CA</span> gene, the PI3K pathway can become overactivated, allowing cancer cells to grow. TOS-358 may slow or stop cancer cells from growing by blocking this pathway.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">PIK3CA</li></ul></span>

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/NCT05683418' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.totusmedicines.com/pipeline' target='_blank'>Totus Medicines: TOS-358 Drug Information Page</a> </li></ul>
12

TOS-358 Targeted Therapy for Advanced HER2- Breast Cancer With a <span class="highlight">PIK3CA</span> Mutation

A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-Alpha Inhibitor, TOS-358, in Adult Subjects With Select Solid Tumors
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Nearest Location from 94107:
421 miles
Comprehensive Cancer Centers of Nevada
Las Vegas, NV

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05683418

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Phase I

13

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

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received treatment with hormone therapy and a CDK4/6 inhibitor. You must not have received chemotherapy or more than 1 line of hormone therapy for advanced disease or have a <span class="highlight">PIK3CA</span> mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 1 week on, 1 week off</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">MammaPrint® and BluePrint are genetic tests that use tumor samples to help guide treatment decisions.</li> <li class="seamTextUnorderedListItem">The tests will also be used to determine if certain mutations are potentially associated with resistance to therapy.</li> <li class="seamTextUnorderedListItem">This trial is for people with non-Luminal A breast cancer. Luminal A breast cancer is ER+, PR+, and HER2- with low Ki-67 levels, which controls how fast cancer cells grow. Luminal A cancers tend to grow more slowly.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05693766' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/molecular-subtypes' target='_blank'>Breastcancer.org: Molecular Subtypes of Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/genetic-testing' target='_blank'>Breastcancer.org: Genetic Testing for Breast Cancer</a> </li></ul>
13

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

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

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05693766

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Phase II

14

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

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

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

Who is this for?: Post-menopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER 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?

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

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive treatment based on ERBB2, <span class="highlight">PIK3CA,</span> 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>
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Hormone Therapy and Targeted Therapy Based on Biomarker Testing for Advanced ER+, HER2- Breast Cancer

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

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Visits:
1 visit every month

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ClinicalTrials.gov: NCT05933395

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Phase II

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