Radiation Therapy for Patients with Early Stage Breast Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT01245712

Provider View

This study is exploring how well radiation therapy works for patients with early stage breast cancer (stage 0-II). The focus is on using a specialized form of radiation that targets the tumor directly, aiming to kill more cancer cells while minimizing damage to healthy tissue.

Patient Parameters

Program Overview

The purpose of this phase II trial is to evaluate the side effects and effectiveness of radiation therapy in treating patients with early stage breast cancer (stage 0-II). The study uses a specialized radiation technique that delivers high doses directly to the tumor, potentially improving treatment outcomes by killing more cancer cells and reducing harm to normal tissue.

Description

The main goals of this study are to assess the cosmetic outcomes, immediate side effects, and long-term side effects in patients receiving accelerated partial breast irradiation with proton radiation.

Additionally, the study aims to evaluate the convenience and quality of life during this treatment and to estimate how well the treatment controls tumors within the breast. Researchers will also compare the radiation dose distribution to other treatment methods.

Patients will receive accelerated partial breast irradiation (APBI) with proton radiation twice a day for 5 days, starting within 10 weeks after their last breast cancer surgery. After completing the treatment, patients will have follow-up visits at 6 weeks, 6 months, 1 year, and 18 months, and then annually for 10 years.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Must have stage 0, I, or II breast cancer, with tumors 3 cm or smaller if stage II.
  • Tumor must be ductal carcinoma in situ (DCIS) or invasive adenocarcinoma.
  • Must have had a lumpectomy with clear margins (no cancer cells at the edges of the removed tissue).
  • Tumor must be unifocal and 3 cm or smaller.
  • For invasive cancer, axillary staging is required, which may include sentinel node biopsy or axillary dissection.
  • The target area for radiation must be clearly defined and less than 30% of the breast volume.
  • Must be technically feasible to deliver partial breast irradiation based on a CT scan.
  • Patients with a history of other cancers are eligible if they have been disease-free for 5 years or more, or if they had certain non-breast cancers treated within the past 5 years.

Exclusion Criteria

  • Men are not eligible.
  • Individuals with cognitive impairments.
  • Breast cancer larger than 3 cm, or stage III or IV.
  • More than 3 positive axillary nodes.
  • Nodes with cancer spread beyond the capsule.
  • Suspicious lymph nodes unless confirmed cancer-free.
  • Suspicious findings on mammogram or ultrasound unless confirmed benign.
  • Non-epithelial breast cancers like sarcoma or lymphoma.
  • Cancer in more than one quadrant or separated by 4 cm or more.
  • Paget's disease of the nipple.
  • Cancer in both breasts at the same time.
  • Positive or unclear surgical margins unless cleared by re-excision.
  • Inability to clearly define the target area for radiation.
  • Plans for regional nodal irradiation.
  • Previous radiation to the affected breast.
  • Certain autoimmune diseases like lupus or scleroderma.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential must use non-hormonal contraception during treatment.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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