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Inavolisib plus endocrine therapy for early-stage PIK3CA‑mutated ER+ HER2‑ breast cancer

A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer

Phase 2 Interventional Hoffmann-La Roche · NCT07054190

This trial will test whether adding inavolisib to endocrine therapy (with ribociclib and letrozole) is safe and helps shrink untreated, early-stage PIK3CA‑mutated ER‑positive, HER2‑negative breast cancer before surgery.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexFemale
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsradiation
Locations30 sites (Orange, California and 29 other locations)
Trial IDNCT07054190 on ClinicalTrials.gov

What this trial studies

This Phase 2, interventional neoadjuvant trial enrolls people with untreated, operable or inoperable Stage II–III ER‑positive, HER2‑negative breast cancer that harbors a confirmed PIK3CA mutation. Participants receive inavolisib in combination with ribociclib and letrozole prior to planned breast surgery, with treatment safety and tumor response tracked over the neoadjuvant period. Key entry requirements include a Ki‑67 ≥5% and willingness to undergo mastectomy or breast‑conserving surgery after therapy when appropriate. Outcomes will include measures of tumor shrinkage and safety/tolerability to inform whether this targeted combination improves preoperative control of PIK3CA‑mutant disease.

Who should consider this trial

Good fit: Ideal candidates are people with untreated, operable or inoperable Stage II–III ER‑positive, HER2‑negative breast cancer with a confirmed PIK3CA mutation who are appropriate for neoadjuvant endocrine combination therapy and plan to have surgery.

Not a fit: Patients with metastatic (Stage IV) disease, inflammatory or bilateral breast cancer, or those without a confirmed PIK3CA mutation are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the regimen could increase tumor shrinkage before surgery and offer a targeted treatment option for patients with PIK3CA‑mutated ER+ HER2‑ breast cancer.

How similar studies have performed: Related PI3K inhibitors such as alpelisib have shown benefit in metastatic PIK3CA‑mutant HR+ breast cancer, but using inavolisib in the neoadjuvant early‑stage setting is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification
* Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
* Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
* Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
* Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
* Documented Ki-67 score \>=5% as per local assessment
* Confirmed PIK3CA mutation

Exclusion Criteria:

* Stage IV (metastatic) BC
* Inflammatory BC (cT4d)
* Bilateral invasive BC
* History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast
* Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, including sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments)
* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes

Where this trial is running

Orange, California and 29 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 2026-06-13 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.