A Study of PF-06873600 in People With Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer

In brief

The purpose of this clinical trial is to learn about the safety and effects of study medicine (PF-06873600) when taken alone or with hormone therapy by people with cancer. People may be able to participate in this study if they have the following types of cancer: Hormone Receptor positive (HR+) breast cancer; Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer that is advanced or metastatic (spread to other parts of the body); triple negative breast cancer; epithelial ovarian cancer; fallopian tube cancer; or primary peritoneal cancer. All participants in this study will receive the study medicine by mouth, 1 to 2 times a day at home. The dose of the study medicine may be changed during the study. Some participants will also receive hormone therapy. The hormone therapy will be either letrozole by mouth once a day at home, or fulvestrant as a shot into the muscle. Fulvestrant will be given every two weeks at the study clinic for the first month, and then once a month after that. Participants will take part in this study for at least 7 to 8 months, depending on how they respond to the therapy. During this time participants will visit the study clinic once a week for the first 2 cycles and every cycle thereafter.

Key facts

Study ID

NCT03519178

Run by

Pfizer

People needed

155

Starts

2018-03-07

Expected to finish

2024-10-30

Last updated by the study team

2025-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer
• Prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of chemotherapy
• Have a diagnosis of metastatic triple negative breast cancer (TNBC)
• Up to 1-2 prior lines of chemotherapy
• Have a diagnosis of advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC)
• Up to 2-3 prior lines of therapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
• Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)
• Measurable disease as defined by RECIST 1.1 is required (Part 1B and Part 2 only)

You may not qualify if…

• Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases
• Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
• Major surgery or radiation within 4 weeks prior to study entry
• Last anti-cancer treatment within 2 weeks prior to study entry
• Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
• Pregnant or breastfeeding female patients
• Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastro intestinal function or GI disease

Where it is running

• University Of Alabama at Birmingham — Birmingham, Alabama, United States
• HonorHealth — Scottsdale, Arizona, United States
• Virginia G. Piper Cancer Center Pharmacy — Scottsdale, Arizona, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Highlands Oncology Group — Rogers, Arkansas, United States
• Highlands Oncology Group — Springdale, Arkansas, United States
• Highlands Oncology — Springdale, Arkansas, United States
• The Oncology Institute of Hope and Innovation — Glendale, California, United States
• The Oncology Institute of Hope and Innovation — Long Beach, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• UCSF Investigational Drugs Pharmacy — San Francisco, California, United States
• The Oncology Institute of Hope and Innovation — Santa Ana, California, United States
• UCLA Hematology/Oncology - Parkside — Santa Monica, California, United States
• UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States
• The Oncology Institute of Hope and Innovation — Whittier, California, United States
• University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) — Aurora, Colorado, United States
• University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) — Aurora, Colorado, United States
• University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) — Aurora, Colorado, United States
• UCHealth Lone Tree Medical Center — Lone Tree, Colorado, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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