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

Trial number:
NCT04191499
Trial phase:
3
Study type:
Hormonal therapy, Targeted therapy
Overall status:
Recruiting

Study start date

January, 2020

Scientific title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib 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 inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants 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 cancerMetastatic 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 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be 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

Metaplastic breast cancerAny 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 may be 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

Study design

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

Conditions

Breast Cancer

Other study ID numbers

WO41554; 2019-002455-42

Choose trial site (399)

National University Hospital 119228
National University Hospital 119228 Recruiting
Singapore 119074
National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting
11 Hospital Crescent, Singapore 169610