Phase II Study Comparing Capecitabine and Elacestrant with Capecitabine Alone in ER+ Breast Cancer (CAPELA)

Sponsor: Kristina A. Fanucci

Sponsor score: 0

ClinicalTrials ID:NCT07222215

Provider View

This study is testing whether combining two drugs, capecitabine and elacestrant, is more effective than using capecitabine alone for treating advanced estrogen receptor-positive (ER+) breast cancer that has stopped responding to certain treatments.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of two drugs, capecitabine and elacestrant, when used together versus capecitabine alone in treating advanced ER+ breast cancer. This study is for patients whose cancer has stopped responding to CDK 4/6 inhibitors like palbociclib, ribociclib, or abemaciclib. Capecitabine is already approved for this type of cancer, while elacestrant is approved for metastatic breast cancer with a specific mutation. The study will involve about 297 participants and includes various tests and procedures to monitor health and treatment effects.

Description

This clinical trial is a Phase II study that involves two groups of participants. One group will receive a combination of capecitabine and elacestrant, while the other group will receive capecitabine alone. Participants are randomly assigned to each group. The study aims to see if the combination of these drugs is more effective in treating advanced ER+ breast cancer that is HER2-negative. Participants will undergo various tests, including blood tests, scans, and heart monitoring, to ensure safety and track the treatment's effectiveness. The study is supported by Stemline, a Menarini Group Company, and Johns Hopkins University.

Eligibility Criteria

Inclusion Criteria

  • Must have advanced ER+ HER2- breast cancer that cannot be removed by surgery.
  • Cancer must have a specific mutation (ESR1) and have stopped responding to certain treatments.
  • Must be 18 years or older.
  • Women must be postmenopausal or on specific hormone treatments.
  • Must have measurable cancer and have tried at least one hormone therapy.
  • Must have tried CDK4/6 inhibitors unless not suitable.
  • Must have good blood, liver, and kidney function.
  • Must agree to use contraception during and after the study.
  • Must be able to swallow pills and understand the study details.
  • HIV-positive participants must have controlled HIV.
  • Participants with hepatitis B or C must have controlled infections.

Exclusion Criteria

  • Cannot have had recent hormone or biological therapy.
  • Cannot be on other experimental treatments.
  • Cannot have rapidly spreading cancer that is life-threatening.
  • Cannot have a specific enzyme deficiency (DPD deficiency).
  • Cannot have active brain cancer unless treated and stable.
  • Cannot have uncontrolled illnesses or infections.
  • Cannot have had another cancer unless treated and stable for 3 years.
  • Cannot be on certain medications that interact with the study drugs.
  • Cannot be pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Dana-Farber Cancer Institute02215BostonMassachusetts

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