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Breast Cancer

PHASE III Trial Comparing Tratuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

Purpose

This study is being done to compare the effects of adding the drug trastuzumab (Herceptin) to breast radiation therapy.  Radiation therapy is the standard treatment for patients with DCIS (Ductal Carcinoma in Situ).

Trastuzumab is called a targeted therapy because it targets breast cancers that make too much of a protein called HER2. Trastuzumab has been shown to block the HER2 protein and to slow down or stop the growth of HER2-positive invasive breast cancers.

In this study, trastuzumab is considered to be investigational as it has not yet been approved for use in the treatment of DCIS.

This study will also look at trastuzumab given without chemotherapy and its effects on the ovaries of women who have not yet gone through menopause.

Eligibility

Eligibility criteria include the following:

  • Must be female
  • Must have a histologically proven DCIS
  • The DCIS must test positive for HER2
  • The DCIS must have been resected by lumpectomy (patients who require a mastectomy are not eligible to be in the study)
  • Registration into the study must be no more than 120 days from the date of the surgery
  • Must not have a prior history of breast cancer
  • Must not have started chemotherapy or radiation therapy prior to registering into the study
  • Must be at least 18 years of age
  • Must not have invasive breast cancer
  • Must not have positive lymph nodes
  • Must not have DCIS in more than one area of the breast
  • Must not have contralateral breast cancer
  • Must not have cardiac disease (angina, arrhythmias, valve disease)
  • Must not have uncontrolled hypertension
  • Must not have other malignancies

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment

Group 1 (Radiation Therapy alone)

  • Whole Breast Irradiation

Group 2 (Radiation Therapy plus trastuzumab)

  • Whole Breast Irradiation
  • Dose 1 of trastuzumab one week before radiation therapy
  • Dose 2 of trastuzumab followed three weeks later

Patients in the study will be followed for 10 years.  The actual study treatment will last approximately 3-6 weeks.