Breast Cancer Clinical Trial

A Study of PF-06873600 in People With Cancer

Summary

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.

View Full Description

Full Description

This is a Phase 1/2a, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-06873600 administered as a single agent in sequential dose levels and then in combination with endocrine therapy. In Part 1A and Part 1C, successive cohorts of patients will receive escalating doses of PF-06873600 and then in dose finding (Part 1B) with PF-06873600 in combination with endocrine therapy (ET). This study contains 2 parts, dose escalation with single agent (Part 1A and 1C) and then dose finding with PF-06873600 in combination with endocrine therapy (Part 1B) followed by dose expansion arms of PF-06873600 in combination with endocrine therapy (Part 2).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

155

Study ID:

NCT03519178

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 45 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
University Of Alabama at Birmingham
Birmingham Alabama, 35249, United States
HonorHealth Research Institute
Scottsdale Arizona, 85258, United States
HonorHealth
Scottsdale Arizona, 85258, United States
Virginia G. Piper Cancer Center Pharmacy
Scottsdale Arizona, 85258, United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Highlands Oncology Group
Rogers Arkansas, 72758, United States
Highlands Oncology Group
Springdale Arkansas, 72762, United States
Highlands Oncology
Springdale Arkansas, 72762, United States
The Oncology Institute of Hope and Innovation
Glendale California, 91204, United States
The Oncology Institute of Hope and Innovation
Long Beach California, 90805, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94143, United States
UCSF Investigational Drugs Pharmacy
San Francisco California, 94158, United States
The Oncology Institute of Hope and Innovation
Santa Ana California, 92705, United States
UCLA Hematology/Oncology - Parkside
Santa Monica California, 90404, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica California, 90404, United States
The Oncology Institute of Hope and Innovation
Whittier California, 90602, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora Colorado, 80045, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora Colorado, 80045, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora Colorado, 80045, United States
UCHealth Lone Tree Medical Center
Lone Tree Colorado, 80124, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
Long Island City New York, 11101, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
The Sarah Cannon Research Institute-Pharmacy
Nashville Tennessee, 37203, United States
The Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio Texas, 78229, United States
Northwest Medical Specialties, PLLC
Federal Way Washington, 98003, United States
Northwest Medical Specialties, PLLC
Gig Harbor Washington, 98332, United States
Rainier Hematology-Oncology PC
Puyallup Washington, 98373, United States
Rainier Hematology-Oncology, PC
Puyallup Washington, 98373, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
Northwest Medical Specialties, PLLC
Tacoma Washington, 98405, United States
Multiprofile Hospital of Active Treatment - Dobrich AD
Dobrich , 9300, Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
Haskovo , 6300, Bulgaria
Complex Oncology Center -Plovdiv
Plovdiv , 4000, Bulgaria
McGill University Health Centre
Montreal Quebec, H4A 3, Canada
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
Kanagawa cancer center
Yokohama Kanagawa, 24185, Japan
Private Medical Institution "Euromedservice"
Pushkin Saint-petersburg, 19660, Russian Federation
BIH of Omsk Region "Clinical Oncological Dispensary"
Omsk , 64401, Russian Federation
BIH of Omsk Region "Clinical Oncological Dispensary"
Omsk , 64404, Russian Federation
LLC "Medicina Severnoy Stolitsy"
Saint-Petersburg , 19102, Russian Federation
LLC "Severo-Zapadny Medical Center"
Saint-Petersburg , 19200, Russian Federation
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Me
Dnipro Dnipropetrovska Oblast, 49102, Ukraine
Kharkiv Regional Specialized Dispensary of Radiation Protection of the Population
Kharkiv Kharkivska Oblast, 61166, Ukraine
Communal nonprofit enterprise "Kyiv City Clinical Oncology Center" of Executive Body of Kyiv City
Kyiv , 03115, Ukraine
Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutica
Lviv , 79031, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

155

Study ID:

NCT03519178

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.