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Clinical Trials List

Protocol NumberWO41554
NCT Number(ClinicalTrials.gov Identfier)NCT04191499
Completed

2019-11-01 - 2026-12-31

Phase III

Recruiting6

ICD-10C50.011

Malignant neoplasm of nipple and areola, right female breast

ICD-10C50.012

Malignant neoplasm of nipple and areola, left female breast

ICD-10C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9174.0

Malignant neoplasm of female breast, nipple and areola

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

  • Trial Applicant

  • Sponsor

    Hoffmann-La Roche

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鍾奇峰 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

  • 褚乃銘 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 戴明燊 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭雨萱 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chiun-Sheng Huang Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Feng Hou Division of General Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

Objectives

The primary efficacy objective for this study is to evaluate the efficacy of GDC-0077 pluspalbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant on thebasis of the following endpoint:  PFS, defined as the time from randomization to the first occurrence of diseaseprogression or death from any cause (whichever occurs first), as determined by theinvestigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1(RECIST v1.1)

Test Drug

GDC-0077；Faslodex；Ibrance

Active Ingredient

Fulvestrant
GDC-0077
Palbociclib

Dosage Form

tablet
IVT
capsule

Dosage

3 mg、9 mg
250 mg/5 ml
75 mg; 100 mg; 125 mg

Endpoints

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, 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 locally advanced or metastatic disease. Specific objectives
and corresponding endpoints for the study are outlined below.

Primary Efficacy Objective
The primary efficacy objective for this study is to evaluate the efficacy of GDC-0077 plus
palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant on the
basis of the following endpoint:
 PFS, defined as the time from randomization to the first occurrence of disease
progression or death from any cause (whichever occurs first), as determined by the
investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1
(RECIST v1.1)

Inclution Criteria

Inclusion Criteria

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

Exclusion Criteria

Exclusion Criteria

Metaplastic breast cancer
Any history of leptomeningeal disease or carcinomatous meningitis
Any prior systemic therapy for metastatic breast cancer
Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases are eligible
Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
Symptomatic active lung disease, or requiring daily supplemental oxygen
History of inflammatory bowel disease or active bowel inflammation
Anti-cancer therapy within 2 weeks before study entry
Investigational drug(s) within 4 weeks before randomization
Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
Chronic corticosteroid therapy or immunosuppressants
Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    320 participants

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