A Study of PF-06873600 in People With Cancer
HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer
About this trial
This is an interventional treatment trial for HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer focused on measuring Hormone Receptor (HR) Positive Breast Cancer, Estrogen receptor (ER) positive, Progesterone receptor (PR) positive, Cyclin-dependent kinase (CDK), Human epidermal growth factor receptor 2 (HER2) negative, Advanced breast cancer, Metastatic breast cancer (MBC), Triple negative breast cancer (TNBC), Epithelial ovarian cancer (EOC), Fallopian tube cancer, Primary peritoneal cancer (PPC), CDK4/6 inhibitor, Endocrine Therapy (ET), Measurable disease, Luteinizing Hormone Releasing Hormone (LHRH) Agonist, Goserelin, Leuprolide acetate
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
Sites / Locations
- University of Alabama at Birmingham
- University Of Alabama at Birmingham
- HonorHealth Research Institute
- HonorHealth
- Virginia G. Piper Cancer Center Pharmacy
- Highlands Oncology Group
- Highlands Oncology Group
- Highlands Oncology Group
- Highlands Oncology
- The Oncology Institute of Hope and Innovation
- The Oncology Institute of Hope and Innovation
- UCSF Helen Diller Family Comprehensive Cancer Center
- UCSF Investigational Drugs Pharmacy
- The Oncology Institute of Hope and Innovation
- UCLA Hematology/Oncology - Parkside
- UCLA Hematology/Oncology - Santa Monica
- The Oncology Institute of Hope and Innovation
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
- University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
- UCHealth Lone Tree Medical Center
- Holy Cross Hospital
- Massachusetts General Hospital
- Brigham & Women's Hospital
- Dana Farber Cancer Institute
- Dana-Farber Cancer Institute
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering Cancer Center
- Tennessee Oncology, PLLC
- The Sarah Cannon Research Institute-Pharmacy
- The Sarah Cannon Research Institute
- The University of Texas MD Anderson Cancer Center
- South Texas Accelerated Research Therapeutics, LLC
- Northwest Medical Specialties, PLLC
- Northwest Medical Specialties, PLLC
- Rainier Hematology-Oncology PC
- Rainier Hematology-Oncology, PC
- Fred Hutchinson Cancer Center
- Seattle Cancer Care Alliance
- University of Washington Medical Center
- Northwest Medical Specialties, PLLC
- Multiprofile Hospital of Active Treatment - Dobrich AD
- Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
- Complex Oncology Center -Plovdiv
- McGill University Health Centre
- National Cancer Center Hospital East
- Kanagawa cancer center
- Private Medical Institution "Euromedservice"
- BIH of Omsk Region "Clinical Oncological Dispensary"
- BIH of Omsk Region "Clinical Oncological Dispensary"
- LLC "Medicina Severnoy Stolitsy"
- LLC "Severo-Zapadny Medical Center"
- Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Me
- Kharkiv Regional Specialized Dispensary of Radiation Protection of the Population
- Communal nonprofit enterprise "Kyiv City Clinical Oncology Center" of Executive Body of Kyiv City
- Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutica
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Dose Escalation
Dose Finding Endocrine Therapy 1 Combination
Dose Finding Endocrine Therapy 2 Combination
Dose Expansion Arm A
Dose Expansion Arm B
Dose Expansion Arm C
Dose Expansion Arm D
Dose Expansion Arm E
Single Agent Dose Escalation
Part 1B PF-06873600 plus Endocrine Therapy 1
Part 1B PF-06873600 plus Endocrine Therapy 2
PF-06873600 as a Single Agent
PF-06873600 as a Single Agent in Various Tumor Types
PF-06873600 in Combination with Endocrine Therapy 1
PF-06873600 in Combination with Endocrine Therapy 1
PF-06873600 in Combination with Endocrine Therapy 2