Study on Shorter Radiation Schedules for Breast Cancer Patients After Surgery

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07076485

Provider View

This clinical trial is exploring whether shorter radiation therapy schedules can be effective for patients with breast cancer who have had surgery and are at higher risk of the cancer returning. The study involves both men and women with node-positive and high-risk node-negative invasive breast cancer.

Patient Parameters

Program Overview

The aim of this study is to find out if shorter schedules of radiation therapy to the lymph nodes can be as effective as the standard schedules for patients who have had surgery for breast cancer. This includes patients who have had either a lumpectomy or mastectomy and are at higher risk of the cancer coming back. The study will look at the side effects, cancer control, survival rates, and patient satisfaction with the treatment.

Description

The main goal of this study is to compare the side effects of different radiation therapy schedules in patients who have had surgery for breast cancer. The study will look at how often patients experience moderate to severe side effects within 18 months of starting radiation therapy.

Secondary goals include comparing the overall side effects, cancer control, survival rates, and patient satisfaction with the treatment. The study will also assess the cosmetic outcomes of the treated breast and the effectiveness of the radiation treatment plans. Additionally, the study will collect data from patients' Apple Watches to monitor health metrics before, during, and after radiation therapy.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed invasive breast cancer.
  • Radiation therapy to the lymph nodes recommended by the doctor.
  • Surgery or chemotherapy completed within the last 12 weeks.
  • Age 18 or older.
  • Able to understand and sign a consent form.
  • Can participate in other studies if they don't conflict with this one.

Low-Risk Lumpectomy Cohort:

  • Had surgery first, with certain cancer stages and no specific lymph node involvement.
  • Treated with lumpectomy.
  • No extra radiation to lymph nodes recommended.

High-Risk Lumpectomy Cohort:

  • Treated with chemotherapy before surgery.
  • Certain cancer stages with lymph node involvement.
  • Treated with lumpectomy.
  • Extra radiation to lymph nodes recommended.

Low-Risk Mastectomy Cohort:

  • Had surgery first, with certain cancer stages.
  • Treated with mastectomy.
  • No extra radiation to chest wall recommended.
  • Age 40 or older.

High-Risk Mastectomy Cohort:

  • Had surgery first, with certain cancer stages.
  • Treated with mastectomy.
  • Extra radiation to chest wall and/or lymph nodes recommended.

Pregnancy Status:

  • Women and men must use effective birth control during radiation treatment.
  • Women must not be pregnant and may need a pregnancy test before starting treatment.

Exclusion Criteria

  • Previous radiation treatment overlapping with the current treatment area.
  • History of scleroderma.
  • Pregnant women cannot participate due to risks from radiation.
  • Patients with psychiatric or social issues that would prevent them from following the study requirements.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas

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