Recruiting
Phase 2

Inavolisib & Fulvestrant

Sponsor:

Hoffmann-La Roche

Code:

NCT07368998

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inavolisib

Fulvestrant

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.

Conditions

Breast Cancer

Study ID

NCT07368998

Start date

Feb 18, 2026

Status verified date

Aug, 2026

Completion date

Oct 31, 2031

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Inavolisib Dose A plus Fulvestrant

Participants will recieve an inavolisib tablet orally (PO) along with fulvestrant as an intramuscular (IM) injection.

experimental: Inavolisib Dose B plus Fulvestrant

Participants will recieve an inavolisib tablet PO along with fulvestrant as an IM injection.

Interventions

Inavolisib

Participants will receive Inavolisib as per the schedule given in the protocol.

Fulvestrant

Participants will receive Fulvestrant as per the schedule given in the protocol.

Primary outcome measure

  • Percentage of Participants With Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]
  • Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: WO46063 https://forpatients.roche.com/ No attachments to email below.

888-662-6728global-roche-genentech-trials@gene.com

Locations

Los Angeles Cancer Network

Recruiting

Los Angeles, California, United States, 90017-4803

Cancer Specialists of North Florida

Recruiting

Jacksonville, Florida, United States, 32256

Astera Cancer Care East Brunswick

Recruiting

East Brunswick, New Jersey, United States, 08816

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-06.