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  3. RLY-2608-102/ReDiscover-2

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

Short Title: RLY-2608-102/ReDiscover-2


Enrollment Status: Recruiting

NCT #: NCT06982521

Specialty Area: Oncology

Condition Studied: Locally Advanced or Metastatic Breast Cancer

Age Groups: Adult; Older Adult

Phase: III


Study Information

Summary / Purpose

To compare the safety and effectiveness of RLY-2608 plus fulvestrant versus capivasertib plus fulvestrant in people with advanced or metastatic HR+/HER2− breast cancer that has a PIK3CA mutation and has progressed after CDK4/6 inhibitor therapy.

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adults 18+ years of age
  • Diagnosed with hormone receptor-positive (HR+), HER2-negative breast cancer with a PIK3CA mutation that is locally advanced or spread beyond the breast (metastatic)
  • Experienced recurrence or progression after treatment with a CDK4/6 inhibitor

What's Involved

Participation in the study will include:
  • Either RLY-2608 or the standard of care capivasertib given orally plus fulvestrant injected into the muscle
  • CT/MRI scans to check response to treatment
  • Blood and urine tests to monitor your health and treatment effects
  • Electrocardiogram (ECG) to monitor heart function
  • Questionnaires

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Complete Study Details: https://clinicaltrials.gov/study/NCT06982521

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.

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