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Adding inavolisib to ribociclib and fulvestrant for HR+ HER2- advanced breast cancer with chr8p loss

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation

Phase 2 Interventional Hoffmann-La Roche · NCT07405801

This trial tests whether adding inavolisib to ribociclib and fulvestrant helps people with endocrine‑therapy‑resistant HR+ HER2‑ advanced breast cancer who have chromosome 8p loss and no PIK3CA mutation.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations19 sites (Marshall, Minnesota and 18 other locations)
Trial IDNCT07405801 on ClinicalTrials.gov

What this trial studies

This Phase II randomized comparison gives participants either inavolisib plus ribociclib and fulvestrant or placebo plus ribociclib and fulvestrant to measure benefit and safety in a biomarker‑selected population. Eligibility requires central laboratory confirmation of chromosome 8p loss and absence of PIK3CA mutation, and participants must be in the first‑line metastatic setting after relapse on or soon after adjuvant endocrine therapy. Participants receive the assigned oral and injectable therapies on protocol schedules and are monitored for adverse events, tumor response, and time to disease progression. The sponsor is Hoffmann‑La Roche and the study is conducted at Avera Cancer Institute sites in Minnesota and South Dakota.

Who should consider this trial

Good fit: Adults with HR+ HER2‑ advanced breast cancer who are endocrine‑therapy‑resistant, have not received prior systemic therapy for metastatic disease, and have central lab‑confirmed chr8p loss without PIK3CA mutation.

Not a fit: Patients whose tumors have PIK3CA mutations, lack chr8p loss, or who have had prior systemic therapy for metastatic disease are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, adding inavolisib could delay disease progression for patients with this specific biomarker profile.

How similar studies have performed: Combinations of CDK4/6 inhibitors with endocrine therapy have improved outcomes in similar populations, but adding inavolisib targeted to chr8p loss is a relatively novel approach with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent
* Documented estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, defined as \>=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020)
* Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen
* Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss)
* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Exclusion Criteria:

* Metaplastic breast cancer
* Radiotherapy within 2 weeks before randomization
* Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis)
* 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 Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible
* Any history of leptomeningeal disease or carcinomatous meningitis

Where this trial is running

Marshall, Minnesota and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast Cancer
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.