Adaptive Therapy with Capecitabine for Treating Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT06525766

Provider View

This study is testing a new approach to using the drug capecitabine for treating breast cancer that is estrogen receptor positive and HER2 negative, and has spread to other parts of the body. The treatment adjusts the dose based on how the cancer responds, aiming to slow or stop tumor growth.

Patient Parameters

Program Overview

This phase II study is exploring how well capecitabine, a cancer drug, works when its dose is adjusted based on tumor response in patients with metastatic estrogen receptor positive, HER2 negative breast cancer. Capecitabine is a type of medication that targets cancer cells and breaks down into a substance that kills them. By adapting the dose according to the tumor's response, the study aims to slow or stop the growth of cancer cells in these patients.

Description

The main goal of this study is to see if adjusting the dose of capecitabine based on how the cancer responds is feasible for patients with hormone receptor positive metastatic breast cancer. Researchers will look at how long it takes for the cancer to progress and overall survival rates. They will also assess patients' quality of life and any side effects from the treatment.

In the initial phase, patients will take a standard dose of capecitabine twice a day for 14 days, with cycles repeating every 21 days. If the cancer responds or remains stable after two cycles, patients will move to the adaptive phase.

In the adaptive phase, the dose of capecitabine will be reduced by 50%. Patients will have regular blood tests and scans to monitor the cancer. If the cancer shrinks by less than 10%, the dose will be further reduced. If the cancer remains stable, the dose will stay the same. If the cancer grows by more than 10%, the dose will be increased. This cycle will continue every 21 days as long as the cancer does not progress or cause unacceptable side effects.

Patients will also have blood samples taken and may undergo additional scans as needed. After completing the study treatment, patients will be followed up every three months for up to three years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of estrogen receptor positive, HER2 negative metastatic breast cancer.
  • Have measurable disease, including bone-only disease with a measurable soft tissue component.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Have adequate blood counts and organ function as determined by specific tests.
  • Not be pregnant and agree to use effective contraception if of childbearing potential.
  • Be willing to provide blood samples for research and undergo required scans.
  • Agree to return for follow-up visits as specified in the study.

Exclusion Criteria

  • Have received prior chemotherapy or antibody drug conjugates for metastatic breast cancer.
  • Be pregnant, nursing, or unwilling to use contraception if of childbearing potential.
  • Have had major surgery within three weeks or radiation therapy within two weeks before starting the study.
  • Have evidence of severe or uncontrolled illness, such as active infection or heart problems.
  • Be taking other investigational drugs for cancer treatment.
  • Have had another active cancer within the past three years, except for certain skin or cervical cancers.
  • Have a history of severe allergic reactions to fluorouracil or capecitabine.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Arizona85259ScottsdaleArizona

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.