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

ConditionsPIK3CA MutationHER2- Negative Breast CancerHormone Receptor Positive TumorBreast CancerMetastatic Breast CancerAdvanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRelay Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

CDK2 inhibitors. Prior treatment with other investigational CDK inhibitors could be permitted upon discussion and approval from the Sponsor

PIK3, AKT, or mTOR inhibitors or any agent whose mechanism of action is the inhibit the PIK3/AKT/mTOR pathway

Immunotherapy

Antibody drug conjugates

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zovegalisib

    Drug

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

  • Capivasertib

    Drug

    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

  • Fulvestrant

    Drug

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

Treatment groups

540 Participants
are divided into 2 treatment groups
Group A: Zovegalisib + fulvestrantExperimental treatment 2 interventions
Group B: capivasertib + fulvestrantActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR)

Time frame
The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months

Secondary outcomes

1

Overall Survival (OS) within the overall and kinase populations

Time frame
The time from randomization to the date of death by any cause, up to approximately 77 months
2

PFS by Investigator within the overall and kinase populations

Time frame
The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months
3

Objective Response Rate (ORR) within the overall and kinase populations

Time frame
Up to approximately 77 months
4

Duration of Response (DOR) within the overall and kinase populations

Time frame
Up to approximately 77 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Relay Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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