Clinical Trial for Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-) and Metastatic Colorectal Adenocarcinoma.

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma

Sex

Male or Female

Age

18+ years

Healthy participants

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Eligibility criteria

Inclusion criteria

18 years of age or older
Advanced or metastatic cancer of the breast or colon Part 1A, 1B, and 1C: HR+/HER2- advanced or metastatic breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and cyclin-dependent kinase (CDK)4/6 inhibitor in the advanced or metastatic setting and received no more than 1 line of prior cytotoxic and/or 1 line of prior antibody-drug conjugate (ADC) therapy in the metastatic setting Part 1D: Metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 2A: HR+/HER2- advanced or metastatic breast cancer with no prior systemic therapy or chemotherapy for advanced or metastatic disease
Phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) mutation
Archived tumor specimen or fresh tumor biopsy
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria

Active or clinically significant dermatologic conditions
Active malignancy within 3 years prior to enrollment
Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term
Major surgery or radiation therapy within 3 weeks prior to study entry
Prior irradiation to >25% of the bone marrow
Active or history of pneumonitis/interstitial lung disease requiring corticosteroids
Unmanageable ascites
Prior treatment with phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT)/mechanistic target of rapamycin (mTOR) pathway inhibitors may be permitted in certain study cohorts and excluded in others, as specified by the study protocol.
Renal impairment
Hepatic dysfunction
Hematologic abnormalities
Uncontrolled diabetes
Cardiac abnormalities
Active or history of clinically significant gastrointestinal (GI) or inflammatory GI disease
Other unacceptable abnormalities or prohibited therapies as defined by protocol

Study overview

The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment given to stop the growth of cancer. This study also aims to find the best amount of study medication that can be given to patients.

This study is seeking participants with a specific type of breast cancer (BC) called hormone receptor-positive (HR+), HER2- negative (HER2-) breast cancer, or colorectal cancer (CRC) (cancer of the colon or rectum), that has a change (mutation) in a gene called PIK3CA. The cancer must be advanced or metastatic, meaning it has spread to other parts of the body or cannot be completely removed with surgery.

All participants in this study will take the study medication (PF-08165784) as a tablet by mouth. The participant may take the medicine at the study clinic during study visits or at home. Treatment will be given in 28-day cycles and will continue for as long as the participant remains in the study. Depending on which part of the study participants are enrolled into, they will receive the study medication (PF-08165784) alone or in combination with other anti-cancer medications.

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A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors

Who may participate

Eligibility criteria

Study overview

View locations for this study

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Join PfizerConnect

A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

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