NCT06982521 - Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer | Biotech Hunter

Enrollment

540

Participants

Timeline

Start Date

August 26, 2025

Primary Completion Date

April 30, 2028

Study Completion Date

December 31, 2031

Conditions

PIK3CA MutationHER2- Negative Breast CancerHormone Receptor Positive TumorBreast CancerMetastatic Breast CancerAdvanced Breast Cancer

Interventions

DRUG

RLY-2608

400 mg orally BID administered daily on a 28-day treatment cycle

DRUG

Capivasertib

400mg orally BID administered on an intermittent weekly dosing schedule. Patients will dose on Days 1 through 4 each week of a 28-day treatment cycle

DRUG

Fulvestrant

500 mg intramuscularly administered on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (28-day treatment cycle)

Trial Locations (8)

32909

RECRUITING

Cancer Care Centers of Brevard, Palm Bay

37203

RECRUITING

Tennessee Oncology, Nashville

48073

RECRUITING

Profound Research LLC, Royal Oak

57105

RECRUITING

Avera Cancer Institute, Sioux Falls

67214

RECRUITING

Cancer Center of Kansas, Wichita

75390

RECRUITING

UT Southwestern Medical Center, Dallas

89502

RECRUITING

Renown Regional Medical Center, Reno

08901

RECRUITING

Rutgers Cancer Institute, New Brunswick

All Listed Sponsors

lead

Relay Therapeutics, Inc.

INDUSTRY