RecruitingPIK3CA MutationHER2- Negative Breast CancerHormone Receptor Positive Tumor

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

Eligible age

18+ yrs

Accepts

All genders

Locations

28 states

Healthy volunteers

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About this study

This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.

Sponsor: Relay Therapeutics, Inc.

You may qualify if…

✓ Patient has ECOG performance status of 0-1
✓ One or more known primary oncogenic PIK3CA mutation(s)
✓ Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with a gonadotropin-releasing hormone (GnRH) agonist. Patients are to have commenced treatment with a GnRH agonist at least 2 weeks prior to randomization and must be willing to continue on it for the duration of the study.
✓ Histologically or cytologically confirmed diagnosis of HR+/HER2- locally advanced or metastatic breast cancer (ABC) with radiological or objective evidence of recurrence or progression; locally advanced disease must not be amenable to resection with curative intent
✓ Measurable disease per RECIST v1.1 or evaluable bone-only disease.
✓ Must have radiological evidence of progression on or after previous treatment for HR+/HER2- ABC with:
✓ 1. At least 1 and no more than 2 lines of endocrine therapy (ET) in the (neo)adjuvant setting with recurrence on or within 12 months of completion or in the ABC setting
✓ 2. Only 1 prior line of CDK4/6 inhibitor therapy in one of the following settings:

You may not qualify if…

✕ Prior treatment with any of the following:
✕ 1. CDK2 inhibitors. Prior treatment with other investigational CDK inhibitors could be permitted upon discussion and approval from the Sponsor
✕ 2. PIK3, AKT, or mTOR inhibitors or any agent whose mechanism of action is the inhibit the PIK3/AKT/mTOR pathway
✕ 3. Immunotherapy
✕ 4. Antibody drug conjugates
✕ Type 1 diabetes, or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥ 140 mg/dL (7.8 mmol/L), or glycosylated hemoglobin (HbA1c) ≥7.0% (≥ 53 mmol/mol).
✕ Clinically significant, uncontrolled cardiovascular disease
✕ Any factors that increase the risk of QTc prolongation or risk of arrhythmic events