Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
155 participants
INTERVENTIONAL
2018-03-07
2024-10-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Single Agent Dose Escalation
PF-06873600
PF-06873600 tablet for oral dosing
Dose Finding Endocrine Therapy 1 Combination
Part 1B PF-06873600 plus Endocrine Therapy 1
PF-06873600
PF-06873600 tablet for oral dosing
Endocrine Therapy 1
Endocrine Therapy 1
Dose Finding Endocrine Therapy 2 Combination
Part 1B PF-06873600 plus Endocrine Therapy 2
PF-06873600
PF-06873600 tablet for oral dosing
Endocrine Therapy 2
Endocrine Therapy 2
Dose Expansion Arm A
PF-06873600 as a Single Agent
PF-06873600
PF-06873600 tablet for oral dosing
Dose Expansion Arm B
PF-06873600 as a Single Agent in Various Tumor Types
PF-06873600
PF-06873600 tablet for oral dosing
Dose Expansion Arm C
PF-06873600 in Combination with Endocrine Therapy 1
PF-06873600
PF-06873600 tablet for oral dosing
Endocrine Therapy 1
Endocrine Therapy 1
Dose Expansion Arm D
PF-06873600 in Combination with Endocrine Therapy 1
PF-06873600
PF-06873600 tablet for oral dosing
Endocrine Therapy 1
Endocrine Therapy 1
Dose Expansion Arm E
PF-06873600 in Combination with Endocrine Therapy 2
PF-06873600
PF-06873600 tablet for oral dosing
Endocrine Therapy 2
Endocrine Therapy 2
Interventions
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PF-06873600
PF-06873600 tablet for oral dosing
Endocrine Therapy 1
Endocrine Therapy 1
Endocrine Therapy 2
Endocrine Therapy 2
Eligibility Criteria
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Inclusion Criteria
• 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
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
Memorial Sloan Kettering Cancer Center
Long Island City, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
The Sarah Cannon Research Institute-Pharmacy
Nashville, Tennessee, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Northwest Medical Specialties, PLLC
Federal Way, Washington, United States
Northwest Medical Specialties, PLLC
Gig Harbor, Washington, United States
Rainier Hematology-Oncology PC
Puyallup, Washington, United States
Rainier Hematology-Oncology, PC
Puyallup, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Multiprofile Hospital of Active Treatment - Dobrich AD
Dobrich, , Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
Haskovo, , Bulgaria
Complex Oncology Center -Plovdiv
Plovdiv, , Bulgaria
McGill University Health Centre
Montreal, Quebec, Canada
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kanagawa cancer center
Yokohama, Kanagawa, Japan
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, Russia
BIH of Omsk Region "Clinical Oncological Dispensary"
Omsk, , Russia
BIH of Omsk Region "Clinical Oncological Dispensary"
Omsk, , Russia
LLC "Medicina Severnoy Stolitsy"
Saint Petersburg, , Russia
LLC "Severo-Zapadny Medical Center"
Saint Petersburg, , Russia
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Me
Dnipro, Dnipropetrovsk Oblast, Ukraine
Kharkiv Regional Specialized Dispensary of Radiation Protection of the Population
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Communal nonprofit enterprise "Kyiv City Clinical Oncology Center" of Executive Body of Kyiv City
Kyiv, , Ukraine
Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical
Lviv, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT03519178
Identifier Type: REGISTRY
Identifier Source: secondary_id
C3661001
Identifier Type: -
Identifier Source: org_study_id