Radiation Therapy (WBI Versus PBI) in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer

Not Recruiting

Trial ID: NCT00103181


RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.

Official Title

A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women With Stage 0, I, or II Breast Cancer

Stanford Investigator(s)

Irene Wapnir, MD
Irene Wapnir, MD

Professor of Surgery (General Surgery)

Frank E. Stockdale
Frank E. Stockdale

Maureen Lyles D'Ambrogio Professor in the School of Medicine, Emeritus



   - Histologically confirmed ductal carcinoma in situ (DCIS*) or invasive* adenocarcinoma
   of the breast

      - Stage 0, I, or II disease

         - Stage II tumors must be ≤ 3 cm

      - Gross disease must be unifocal

         - Microscopic multifocality allowed provided total pathological tumor size is
         ≤ 3 cm

      - No proven multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm

      - No non-epithelial breast malignancies (e.g., sarcoma or lymphoma) NOTE: *Patients
      who are 50 years of age and over with DCIS regardless of hormone receptor status
      AND patients with invasive breast cancer meeting all of the following criteria: ≥
      50 years of age, node-negative, and hormone-receptor positive status will not be
      enrolled in study after 12/30/2006

   - Prior axillary staging required for patients with invasive breast cancer, including 1
   of the following:

      - Sentinel node biopsy alone (if sentinel node is negative)

      - Sentinel node biopsy followed by axillary dissection or sampling with ≥ 6
      axillary nodes (if sentinel node is positive)

      - Axillary dissection alone with ≥ 6 axillary nodes

   - No more than 3 positive axillary nodes

      - No axillary nodes with definite evidence of microscopic or macroscopic
      extracapsular extension

      - No positive non-axillary sentinel nodes (intramammary nodes are staged as
      axillary nodes)

      - No palpable or radiographically suspicious ipsilateral or contralateral axillary,
      supraclavicular, infraclavicular, or internal mammary nodes unless there is
      histologic confirmation that these nodes are negative for tumor

   - Must have undergone lumpectomy

      - Resected margins histologically free of tumor

      - Re-excision of surgical margins allowed

      - Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast
      reference volume ≤ 30% based on postoperative pre-randomization CT scan

      - Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging
      procedure) within the past 42 days

   - No suspicious microcalcifications, densities, or palpable abnormalities in the
   ipsilateral or contralateral breast unless biopsied and found to be benign

   - No Paget's disease of the nipple

   - No history of invasive breast cancer or DCIS

      - Prior lobular carcinoma in situ treated by surgery alone allowed

   - No synchronous bilateral invasive or non-invasive breast cancer

   - Partial breast irradiation deemed technically deliverable by radiation oncologist at a
   credentialed facility

   - Must have undergone a history and physical exam within the past 4 months AND a
   bilateral mammogram within the past 6 months

   - Hormone receptor status:

      - Estrogen receptor (ER) status known

      - Progesterone status known if ER analysis is negative

      - Marginal or borderline results are considered positive



   - 18 and over


   - Female

Menopausal status

   - Premenopausal or postmenopausal

Performance status

   - Not specified

Life expectancy

   - At least 10 years, excluding diagnosis of breast cancer


   - Not specified


   - Not specified


   - Not specified


   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective non-hormonal contraception

   - No other malignancy within the past 5 years except previously treated carcinoma in
   situ of the cervix or colon, melanoma in situ, or basal cell or squamous cell skin

      - Deemed to be at low risk for recurrence

   - No collagen vascular disease (e.g., systemic lupus erythematosus or scleroderma),
   specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal,
   or active skin rash

   - No psychiatric or addictive disorder that would preclude study therapy


Biologic therapy

   - No prior biologic therapy for this malignancy


   - No prior chemotherapy for this malignancy

   - No concurrent chemotherapy during study radiotherapy

Endocrine therapy

   - No prior hormonal therapy for this malignancy unless total duration of hormonal
   therapy was no more than 28 days before randomization

   - Concurrent hormonal therapy allowed provided it is not administered during

   - No concurrent raloxifene, tamoxifen, or other selective estrogen receptor modulating

   - No concurrent hormone replacement therapy

   - No concurrent Femring^®


   - No prior radiotherapy for this malignancy

   - No prior breast or thoracic radiotherapy

   - No concurrent brachytherapy boosts

   - No concurrent intensity modulated radiotherapy

   - No concurrent regional nodal irradiation


   - See Disease Characteristics

   - No prior breast implants

      - Patients who have had implants removed are eligible


   - No other concurrent anticancer therapy


radiation: 3-dimensional conformal accelerated partial breast irradiation

radiation: brachytherapy

radiation: whole breast irradiation

radiation: MammoSite or other single-entry intracavitary device

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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