West Cancer Center

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

Title

Roche WO45654 (Breast 1st line PIK3CA)

Study Title

Site Link

NCT06790693

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

Gary Tian MD, PhD

Sponsor

Roche Genentech

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

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

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Estrogen receptor positive, HER2 negative

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes