Breast CancerOpen to EnrollmentPhase 3

BREAST: METASTATIC: ER+/HER2-: PIK3CA mt: 1st Line: WO45654

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

View on ClinicalTrials.gov Browse more trials

Study snapshot

Title: Roche WO45654 (Breast 1st line PIK3CA)
Malignancy: Breast cancer, ER+ breast cancer, HER2 negative breast cancer, IBC
Stage: Stage 4
Disease setting: Metastatic/Palliative
Line of therapy: 1st Line endocrine
Investigational agent: inavosalib
Drug class: PI3k inhibitor
Principal investigator: Gary Tian MD, PhD
Sponsor: Roche Genentech
Path: Estrogen receptor positive, HER2 negative
Randomized: Yes
ClinicalTrials.gov ID: NCT06790693

Eligibility and objectives

Key eligibility criteria details

Women or men with breast carcinoma
Documented ER-positive and/or PR positive
PIK3CA mutation
Documented HER2-negative
De-novo HR+, HER2- ABC, or alternatively relapsed HR+, HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment
Bilateral breast cancer is allowed if both HR+/HER2-
Measurable disease
ECOG PS 0-1
No metaplastic breast cancer
No known or untreated CNS mets. History of treated CNS mets allowed
No active lung disease
No history of IBD

Objective

Primary
- PFS
Secondary
- OS
- ORR
- DOR
- CBR
- Time to confirmed deterioration
- Safety
- PRO

Study snapshot

Eligibility and objectives

Key eligibility criteria details

Objective

Treatment details