A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Inavolisib — DRUG
  Participants will be administered a 9 milligram (mg) inavolisib tablet orally once a day (PO QD) on Days 1-28 of each 28-day cycle of main study and sub-study.
• Fulvestrant — DRUG
  Participants will be administered 500 mg of fulvestrant on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28-day cycle of main study and sub-study.
• Alpelisib — DRUG
  Alpelisib will be administered to participants at the approved dose in combination with fulvestrant: 300 mg taken PO QD and on days 1-28 of each 28-day cycle.
• Bupropion — DRUG
  Participants will be administered bupropion PO on Day -3 and Day 12 of Cycle 1 of the sub-study.
• Omeprazole — DRUG
  Participants will be administered omerprazole PO on Day -4 and Day 11 of Cycle 1 of sub-study.
• Midazolam — DRUG
  Participants will be administered midazolam PO on Day -4 and Day 11 of Cycle 1 of sub-study.

Study Details

This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.

Key Dates

First listed

Dec 12, 2022

Start date

Jun 7, 2023

Status verified

Aug 2026

Primary completion

Nov 13, 2026

Completion

Mar 30, 2029

Study Design

Enrollment

420 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Inavolisib + Fulvestrant
  Participants will be administered the treatments as outlined in the interventions section.
• Active Comparator: Alpelisib + Fulvestrant
  Participants will be administered the treatments as outlined in the interventions section.
• Experimental: Sub-study: Inavolisib + Fulvestrant + CYP substrates
  Participants will be administered the treatments as outlined in the interventions section.

Primary Outcome Measure

Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS) [ Time Frame: From randomization until disease progression or death due to any cause (up to approximately 64 months) ]

Central Contacts

• Reference Study ID Number: WO43919 https://forpatients.roche.com/ No attachments to email below
  888-662-6728 (U.S. and Canada)
  [email protected]
• Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (39)

Find similar trials in Greenbrae, CA

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