A Safety, Pharmacokinetic, Pharmacodynamic and Anti-Tumor Study of PF-06873600 in Combination With Endocrine Therapy

Phase 1

• Conditions: HR+ HER2- Metastatic Breast Cancer (Part 1 also had Ovarian Cancer and Triple Negative BC); MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-001757-40-BG
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-23
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

•Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer and prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of chemotherapy (Part 2A).
•Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer and has not received a CDK 4/6 inhibitor as treatment as an adjuvant or as treatment is the advanced or metastatic setting and has also not received an aromatase inhibitor in the advanced or metastatic setting (prior adjuvant therapy with AI is permitted). One prior line of cytotoxic chemotherapy in the advanced or metastatic setting is allowed (Part 2B)
•Have a diagnosis of Horne Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer and has not received a CDK 4/6 inhibitor as treatment as an adjuvant or as treatment is the advanced or metastatic setting. Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre- or peri-menopausal OR progressed while on or within 1 month after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer if postmenopausal, or prior endocrine treatment for advanced/metastatic breast cancer if pre- or peri menopausal. One prior line of cytotoxic chemotherapy in the advanced or metastatic setting is allowed (Part 2C).
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
•Measurable disease as defined by RECIST 1.1 is required
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified