Study on 3-Day Partial Breast Radiation Therapy for Women with Breast Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04084730

Provider View

This clinical trial is exploring whether a shorter, 3-day course of radiation therapy is safe and effective for women with newly diagnosed breast cancer or DCIS who have had a lumpectomy. The study aims to see if this approach causes few or mild side effects.

Patient Parameters

Program Overview

The purpose of this study is to find out if delivering radiation therapy over a shorter period of three days is a safe and effective way to treat women with newly diagnosed breast cancer or ductal carcinoma in situ (DCIS) who have undergone a lumpectomy. Researchers want to see if this method can produce a good treatment response while keeping side effects mild or minimal.

Eligibility Criteria

Inclusion Criteria

  • Women aged 45 years or older.
  • Diagnosed with a single tumor of stage I invasive ductal breast cancer or DCIS, less than 3 cm in size.
  • Women aged 70 or older with small, hormone-positive tumors and no lymph node involvement may also qualify.
  • Tumor margins must be clear of cancer cells.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Negative pregnancy test for women of childbearing potential.
  • Willing to use effective birth control during the study.
  • Able to provide written informed consent.

Additional criteria for intermediate risk group:

  • Specific tumor characteristics or genetic scores indicating higher risk.
  • Age 40-49 with no history of certain breast conditions or family history of breast cancer.
  • Invasive lobular carcinoma or close surgical margins.

Exclusion Criteria

  • Cancer that has spread to other parts of the body.
  • Pregnant or breastfeeding women.
  • Multiple or large areas of suspicious microcalcifications or multiple tumors.
  • Previous radiation therapy to the breast or chest.
  • Extensive cancer spread in lymph or ducts.
  • Known genetic mutations like BRCA1 or BRCA2.
  • History of cosmetic or reconstructive breast surgery.
  • Serious medical conditions like uncontrolled infections or diabetes.
  • Active second cancer, except for certain skin cancers.
  • Participation in other cancer treatment trials.
  • Planning to conceive during the study period.
  • Ongoing treatment with other investigational drugs.

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