Study on Regional Radiotherapy for Low-Risk Node Positive and T3N0 Breast Cancer

Sponsor: Canadian Cancer Trials Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03488693

Provider View

This clinical trial is exploring whether skipping regional radiation therapy in low-risk breast cancer patients is as effective as including it in the usual treatment plan. The goal is to see if avoiding this type of radiation can still prevent the cancer from returning.

Patient Parameters

Program Overview

The study aims to compare the effects of usual care, which includes regional radiation therapy, with not giving this type of radiation to women with low-risk breast cancer. Researchers want to find out if not using regional radiation therapy works just as well in preventing the cancer from coming back, potentially sparing patients from unnecessary side effects.

Description

Women with node-positive breast cancer typically receive treatments like hormone therapy and sometimes chemotherapy to help prevent the cancer from returning. Many also receive radiation therapy to the breast or chest area and nearby lymph nodes, known as regional radiotherapy. However, it's unclear if women with low-risk breast cancer need this regional radiotherapy. Some women might be receiving it without any real benefit, exposing them to side effects unnecessarily.

Eligibility Criteria

Inclusion Criteria

  • Women with newly diagnosed invasive breast cancer, confirmed by lab tests, with no signs of cancer spread.
  • Must have had breast-conserving surgery or mastectomy with clear margins. Multifocal or multicentric disease is allowed.
  • Eligible if diagnosed with T3N0 disease or if cancer is limited to small nodal metastases.
  • If treated by axillary dissection, must have 1-3 positive nodes; if treated by mastectomy and sentinel lymph node biopsy, must have 1-2 positive nodes.
  • Cancer must be estrogen receptor-positive (ER ≥ 1%) and HER2 negative.
  • Must have an Oncotype DX recurrence score of 25 or lower.
  • Must agree to provide tumor tissue and blood samples for research.
  • Must have started or plan to start hormone therapy for at least 5 years.
  • May or may not have received chemotherapy.
  • Radiation therapy must start within 16 weeks of surgery if no chemotherapy, or within 12 weeks after chemotherapy.
  • Must have an ECOG performance status of 0, 1, or 2.
  • Must be 35 years or older.
  • Must be able to complete quality of life questionnaires in English or French.
  • Must agree to use effective contraception if of childbearing potential.
  • Must be available for treatment and follow-up.
  • Treatment must start within 6 weeks of randomization.

Exclusion Criteria

  • Cancer limited to isolated tumor cells smaller than 0.2 mm.
  • Diagnosed with pT3N1 or pT4 disease.
  • Previous history of breast cancer on the same side treated with radiation.
  • Previous or simultaneous breast cancer on the opposite side, unless it was DCIS not treated with radiation.
  • History of other cancers, except certain skin cancers or cancers treated successfully over 5 years ago.
  • Pregnant women.
  • Previous chest wall or thoracic radiation.
  • Received chemotherapy or hormone therapy before surgery, except hormone therapy within 12 weeks before surgery.
  • Serious non-cancerous diseases that would prevent radiation therapy.
  • Serious medical conditions or infections that would prevent participation in the study.

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