Alpelisib + Trastuzumab + Pertuzumab for Breast Cancer
(EPIK-B2 Trial)

Recruiting in Palo Alto (17 mi)

+42 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tested a combination of drugs for patients with advanced breast cancer that has a specific genetic mutation. The goal was to see if this combination could better control the cancer by blocking growth signals. The study was stopped due to changes in treatment approaches, not because of safety issues.

Eligibility Criteria

This trial is for HER2-positive advanced breast cancer patients with a PIK3CA mutation who completed up to 8 cycles of taxane-based therapy. They must have good performance status and organ function, no inflammatory breast cancer, uncontrolled heart issues, history of severe skin reactions or lung disease, diabetes type I or uncontrolled type II.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I've had up to 8 treatments with specific drugs for my cancer, or stopped at 4-5 due to side effects.

My bone marrow and organs are functioning well.

+2 more

Exclusion Criteria

I have been diagnosed with type I diabetes or my type II diabetes is not under control.

I have been diagnosed with inflammatory breast cancer.

I have serious heart problems that are not under control.

+4 more

Participant Groups

The study tests the effectiveness and safety of Alpelisib in combination with Trastuzumab and Pertuzumab as maintenance therapy post-taxane induction. It's a two-part study: an initial phase to confirm safe dosage followed by a randomized comparison with placebo.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2: Alpelisib + Trastuzumab + PertuzumabExperimental Treatment3 Interventions

Trastuzumab (6mg/kg) + pertuzumab (420 mg) in combination with 200mg alpelisib, with potential for intra-participant dose escalation to 250 mg

Group II: Part 1: Alpelisib + Trastuzumab + PertuzumabExperimental Treatment3 Interventions

In the Part 1, up to 3 alpelisib dose levels may be sequentially tested in 3 cohorts of subjects: Cohort A: Alpelisib 300mg + trastuzumab (6mg/kg) + pertuzumab (420 mg) Cohort B: Alpelisib 250 mg+ trastuzumab (6mg/kg) + pertuzumab (420 mg) Cohort C: Alpelisib 200mg + trastuzumab (6mg/kg) + pertuzumab (420 mg)

Group III: Part 2: Alpelisib matching Placebo + Trastuzumab + PertuzumabPlacebo Group3 Interventions

Trastuzumab (6mg/kg) + pertuzumab (420 mg) in combination with 200 mg alpelisib matching placebo, with potential for intra-participant dose escalation to 250 mg