A Phase I Study of Exercise Treatment with Standard Therapy for Metastatic Breast Cancer

Print

Full Title

Phase 1a/1b Trial of Exercise Treatment with Concurrent First-Line Therapy for Hormone Receptor Positive Metastatic Breast Cancer

Purpose

The purpose of this study is to determine the amount of aerobic exercise that is beneficial to patients receiving initial therapy for newly diagnosed metastatic breast cancer that contains hormone receptors and is negative for the HER2 protein. Researchers believe that exercise may help delay the development of resistance to hormone therapy while slowing the growth of breast tumors.

The researchers will assess increasing amounts of weekly exercise (walking on a treadmill) in different groups of study participants. All participants in this study will be required to exercise for a certain number of minutes per week. A treadmill, activity tracker, and other equipment will be shipped to their homes for use during the study, and these items will be returned to Memorial Sloan Kettering when study participation is complete. Participants will communicate with the study team through virtual visits using an electronic tablet provided to them.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Participants must be postmenopausal (or be receiving ovarian suppression therapy) and have previously untreated metastatic breast cancer that is positive for hormone receptors and negative for HER2.
  • Patients must enroll in the study within 3 weeks of starting initial hormonal therapy (tamoxifen, aromatase inhibitor, or fulvestrant) with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Neil Iyengar at 646-888-8103.

Protocol

19-113

Phase

I

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

Jones, Lee, PhD

Diseases