Study Comparing Radiation Treatment Schedules for Post-Menopausal Women with Early-Stage Breast Cancer

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40

ClinicalTrials ID:NCT02755896

This clinical trial is exploring two different radiation treatment schedules for post-menopausal women with early-stage breast cancer. The study aims to determine which schedule is more effective and has fewer side effects.

Patient Parameters

Program Overview

The study involves post-menopausal women with early-stage breast cancer who will receive radiation therapy after surgery. Participants will be randomly assigned to one of two groups: one group will receive radiation over five consecutive days, while the other group will receive it every other day for three sessions. The goal is to see which schedule is better at controlling cancer and minimizing side effects. Participants will be monitored for a month after treatment, then every six months for the first year, and annually for the next ten years.

Description

This trial is investigating a new approach to radiation therapy for breast cancer called Partial Breast Irradiation (PBI). Unlike traditional whole breast radiation, PBI targets only the part of the breast where the cancer was removed. This study compares two different PBI schedules to see which is more effective and has fewer side effects. The first schedule involves five sessions over five days, and the second involves three sessions every other day. PBI is less invasive than other methods and doesn't require surgery or anesthesia. It's also more accessible since it can be done at any facility with the right equipment. The study is open to post-menopausal women who have had surgery to remove early-stage breast cancer and meet specific health criteria. Participants will be closely monitored to ensure the treatment is safe and effective.

Eligibility Criteria

Inclusion Criteria

  • Post-menopausal women who have had surgery to remove early-stage breast cancer.
  • Must be at least two years without a menstrual period, or over 50 with blood tests confirming menopause, or have had a hysterectomy with tests confirming menopause.
  • Cancer must be stage 1 and completely removed with no cancer cells at the edges of the removed tissue.
  • No cancer spread to lymph nodes.

Exclusion Criteria

  • Previous radiation treatment to the same breast.
  • Presence of a type of breast cancer called Ductal Carcinoma in-situ (DCIS) that is widespread in the biopsy sample.

Locations

FACILITYZIPCITYSTATE
University of Southern California90033Los AngelesCalifornia
Weill Cornell Medical College10065New YorkNew York
Brooklyn Methodist Hospital - NewYork Presbyterian11215New YorkNew York
New York Presbyterian Hospital - Queens11355New YorkNew York

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