Recruiting

A Study Evaluating the Efficacy and Safety of GDC-0077 + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

# NCT04191499 Trial phase: 2, 3 Study type: hormonal, targeted

Study Start Date

January, 2020

Scientific Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GDC-0077 Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of GDC-0077 in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

- Confirmed diagnosis of HR+/HER2- breast cancer - Metastatic or locally advanced disease not amenable to curative therapy - Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen - Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal - Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test) - Consent to provide fresh or archival tumor tissue specimen - Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1; "bone-only" disease, even if considered measurable, is not eligible - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Life expectancy of > 6 months - Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Study Design

Primary purpose: Treatment , Allocation: Randomized , Intervention model: Parallel Assignment , Masking: Double , Subject masked: Yes , Investigator masked: Yes

Conditions

Breast Cancer

Locations

Roche

Roche

Official trial

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