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RecruitingLast updated: 15 May 2026

optINAVO: Evaluating a targeted medicine called inavolisib when given with hormone therapy in people with PIK3CA-mutated, HR+, HER2-negative advanced or metastatic breast cancerA Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People18+

Trial acronym

optINAVO

Clinical summary

Summary

The purpose of this study is to find out how well and how safely the study medicine, inavolisib, works when it is given together with fulvestrant hormone therapy. 

The study is for people with breast cancer that: 

  • has a PIK3CA gene change
  • is hormone receptor (HR) positive
  • is HER2-negative
  • has spread or cannoy be removed with surgery
  • has been previously treated with a CDK inhibitor

The goal is to see if this combination treatment can help control the cancer and to better understand any side effects.

All eligible participants will receive inavolisib together with fulvestrant. However, participants will be randomly assigned (by chance) to receive one of two different doses of inavolisib: Dose A or Dose B. 

Conditions

This trial is treating people with ER+, HER- locally advanced or metastatic breast cancer with a PIK3CA mutation

Eligibility

Inclusion

  • Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
  • Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting
  • Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
  • Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
  • Confirmation of biomarker eligibility: presence of >= 1 study-eligible PIK3CA mutation
  • Life expectancy of > 6 months
  • Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes

Exclusion

  • Metaplastic breast cancer
  • Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
  • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
  • Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
  • Requirement for daily supplemental oxygen
  • Symptomatic active lung disease, including pneumonitis

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

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