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A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.

NCT07618390 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-06-01

No results posted yet for this study

Summary

This is a prospective, multicenter, open-label, single-arm phase II investigator-initiated study designed to evaluate the efficacy and safety of inavolisib in combination with ribociclib and fulvestrant as first-line treatment in Chinese patients with PIK3CA-mutant, hormone receptor-positive (HR+), HER2-negative (HER2-), endocrine-resistant metastatic breast cancer (mBC). Approximately 160 patients will be enrolled at around 16 centers in China.

The study consists of a screening period of up to 28 days, a treatment period, and a post-treatment follow-up period.

PIK3CA mutation status must be determined in blood or tumor tissue using polymerase chain reaction (PCR)-based assays or next-generation sequencing (NGS) performed in a local clinical laboratory. Patients with locally confirmed PIK3CA mutations who meet all eligibility criteria will be enrolled and receive study treatment with inavolisib, ribociclib, and fulvestrant. Details of the treatment regimen are provided in the Study Treatment section. Study treatment will continue until radiologically confirmed disease progression as determined by the investigator, unacceptable toxicity, withdrawal of informed consent, or study termination, whichever occurs first.

Patients must have measurable disease according to RECIST v1.1. Patients with bone-only metastases are not eligible, even if the lesions are considered measurable. Locally advanced disease must be unsuitable for surgical resection or other local treatment with curative intent.

Conditions

Interventions

DRUG

Inavolisib + Ribociclib + Fulvestrant

A total of 160 Chinese patients who meet the eligibility criteria and are confirmed to have PIK3CA-mutant breast cancer will receive the following treatment regimen: * \*\*Inavolisib:\*\* 9 mg tablet, administered orally once daily (PO QD), on Days 1-28 of each 28-day cycle, starting from Cycle 1 Day 1; * \*\*Ribociclib:\*\* 600 mg capsule or tablet, administered orally once daily (PO QD), on Days 1-21 of each 28-day cycle, starting from Cycle 1 Day 1; * \*\*Fulvestrant:\*\* 500 mg administered by intramuscular injection (IM) on Days 1 and 15 of Cycle 1, and thereafter on Day 1 of each subsequent 28-day cycle (approximately every 4 weeks).

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07618390 on ClinicalTrials.gov