CLEVER Pilot Trial: Testing Hydroxychloroquine, Everolimus, or Both for Preventing Breast Cancer Recurrence

Sponsor: Abramson Cancer Center at Penn Medicine

Sponsor score: 0

ClinicalTrials ID:NCT03032406

Provider View

This study is exploring whether taking hydroxychloroquine, everolimus, or a combination of both can help prevent breast cancer from coming back in patients who have completed their initial treatment and have certain cancer cells in their bone marrow.

Patient Parameters

Program Overview

The CLEVER Pilot Trial is investigating if hydroxychloroquine (HCQ), everolimus (EVE), or a combination of both can be safely given to patients who have finished their primary breast cancer treatment. The study focuses on patients who still have cancer cells in their bone marrow, which could lead to a recurrence of breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary invasive breast cancer within the last 5 years.
  • Must meet certain risk criteria based on receptor testing, such as having positive lymph nodes or specific tumor characteristics.
  • Completed all primary treatments like surgery, chemotherapy, and radiation at least 4 weeks before joining the study.
  • No signs of breast cancer recurrence based on exams and tests.
  • Age 18 or older.
  • Good overall health with specific blood and organ function levels.
  • Able to provide informed consent.

Exclusion Criteria

  • Currently in another clinical trial.
  • Previously treated with certain mTOR inhibitors.
  • Allergic to everolimus or similar drugs.
  • Taking high doses of steroids or other immune-suppressing medications.
  • Have severe or uncontrolled medical conditions, such as heart failure or lung disease.
  • Have active infections or liver disease.
  • Pregnant or breastfeeding women, or those not using effective birth control.

Locations

FACILITYZIPCITYSTATE
Abramson Cancer Center of the University of Pennsylvania19104PhiladelphiaPennsylvania

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