Refer a Patient

If you have a patient with HR+/HER2- locally advanced or metastatic breast cancer whose tumor has a mutation in a gene called PIK3CA, they may be eligible to participate in the ReDiscover-2 Study.

Find a participating site

About the ReDiscover-2 Study

The ReDiscover-2 Study is evaluating an investigational study drug in participants living with locally advanced or metastatic breast cancer whose tumor has a mutation in the PIK3CA gene. The trial aims to learn more about the safety and effectiveness of the study drug in comparison to a standard approved treatment.

Study Purpose

The purpose of the ReDiscover-2 Study is to assess the efficacy and safety of RLY-2608 + fulvestrant versus TRUQAP™ (capivasertib) + fulvestrant as treatment for PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor.

Study Design

This is a Phase 3, open-label, randomized trial that is enrolling approximately 540 participants globally to receive either RLY-2608 in combination with fulvestrant or TRUQAP™ (capivasertib) in combination with fulvestrant.

Patients who join the ReDiscover-2 Study will participate in the trial for several months or up to a year or longer. During that time, there will be a screening period, treatment period, and follow-up period. Participants will visit the study site approximately once per month during the treatment period.

For additional trial details, visit ClinicalTrials.gov.

About the Investigational Study Drug

The investigational study drug, RLY-2608, is an oral capsule taken twice daily. TRUQAP™ (capivasertib) is an oral tablet taken twice daily for 4 days followed by 3 days off every week. Fulvestrant is administered at the study site as 2 injections given twice in the first cycle, then once per cycle thereafter.

Key Eligibility Criteria

To be considered for the trial, eligible participants must have:

  • HR+/HER2- advanced breast cancer
  • Any PIK3CA mutation with no known PTEN or AKT mutation
  • HbA1c < 7% and fasting plasma glucose < 140 mg/dL at baseline
  • Progression in metastatic or adjuvant setting on or after:
    • 1 prior CDK4/6 inhibitor, and
    • 1 or 2 prior endocrine therapies
  • No more than 1 prior line of chemotherapy
  • 6 months or longer duration of therapy on frontline ET regimen

Eligible participants must NOT:

  • Have metaplastic or inflammatory breast cancer
  • Have prior treatment with any of the following:
    • CDK2 or selective CDK4 inhibitors or any investigational therapies targeting CDKs
    • PI3K, AKT, or mTOR inhibitors, or any agent whose mechanism of action is to inhibit the PI3K/AKT/mTOR pathway
    • Immunotherapy
    • Antibody drug conjugates
  • Have known activating AKT mutations, loss-of-function PTEN mutations, or loss of PTEN expression resulting in oncogenic pathway activation downstream of PI3K

Refer a Patient

If you have a patient who may be interested in participating, and you think may qualify, refer your patient to this trial website.

Find a Site Near You

To learn more or refer a patient, please contact the Relay Therapeutics team. You can also view the full list of participating research sites or search by location to determine which site you are interested in referring a patient to.

Active site locations

Future site locations