Radiation Therapy in Treating Women With Early Stage Breast Cancer

Sponsor: Rutgers, The State University of New Jersey

Sponsor score: 40

ClinicalTrials ID:NCT00909909

This phase II trial evaluates the side effects and efficacy of accelerated, hypofractionated radiotherapy in women post-lumpectomy or mastectomy. It assesses local/regional failure, toxicity, and cosmetic outcomes. Interventions include intracavitary brachytherapy, 3D-CRT/IMRT, and whole breast/chest wall irradiation. Follow-ups occur over several years to monitor outcomes.

Patient Parameters

Program Overview

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.

Description

OBJECTIVES:

Primary

  • To determine the freedom from local and regional failure in women with early stage breast cancer treated with accelerated, hypofractionated radiotherapy.
  • To determine the acute and late toxicity of accelerated, hypofractionated radiotherapy using previously published toxicity scales.

Secondary

  • To measure cosmesis using the Harvard cosmesis scale in patients who have undergone lumpectomy.
  • To identify co-variates responsible for poor cosmetic outcome in these patients.

OUTLINE: Patients who have undergone lumpectomy undergo either intracavitary balloon brachytherapy boost and hypofractionated, accelerated whole breast irradiation (AWBI) OR 3D-conformal radiotherapy (3D-CRT)/intensity-modulated radiotherapy (IMRT) boost and AWBI. Patients who have undergone mastectomy undergo hypofractionated, accelerated chest wall irradiation.

  • Intracavitary balloon brachytherapy boost and AWBI (post-lumpectomy): Patients undergo intracavitary balloon brachytherapy boost twice daily for 2 days (total of 4 fractions). Beginning 5-21 days after completion of brachytherapy, patients undergo AWBI once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
  • 3D-CRT/IMRT boost and AWBI (post-lumpectomy): Patients undergo 3D-CRT/IMRT boost twice daily for 2 days (total of 4 fractions). Patients also undergo AWBI as above before or after boost radiotherapy.
  • Accelerated chest wall irradiation (post-mastectomy): Patients undergo accelerated chest wall irradiation once daily 5 days a week for approximately 2 weeks (total of 11 fractions).

Patients who have undergone lumpectomy undergo frontal digital photography of the breasts at baseline, immediately before the initiation of radiotherapy, and then annually for 3 years after completion of radiotherapy. These patients also complete the Breast Cancer Treatment Outcome Scale at baseline and at 3 years after completion of radiotherapy. Physicians complete the Harvard Cosmesis scale at baseline and at 1 and 3 years after completion of radiotherapy.

After completion of study treatment, patients are followed up at weeks 1, 4, and 8 and then every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer, including 1 of the following subtypes:

    • Ductal carcinoma in situ
    • Invasive ductal carcinoma
    • Invasive lobular carcinoma
    • Medullary carcinoma
    • Papillary carcinoma
    • Colloidal (mucinous) carcinoma
    • Tubular carcinoma

  • Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0)

    • Tumor size ≤ 5 cm

  • Breast considered technically satisfactory for radiotherapy

  • Has undergone lumpectomy or mastectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)

    • Negative inked histological margins (i.e., no invasive cells at surgical margin) or confirmed negative re-excision specimen

  • Unifocal or multifocal (confined to 1 quadrant; tumors < 4 cm apart) disease with 1 or 2 foci that can be encompassed by 1 lumpectomy

  • No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by ≥ 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy

  • No evidence of suspicious microcalcifications in the breast before the start of radiotherapy

    • If malignancy-associated microcalcifications were initially present, the post-excision mammography must be negative

  • No more than 9 positive axillary lymph nodes

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

  • No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer

  • No lobular carcinoma in situ alone (i.e., no invasive component) or non-epithelial breast malignancies (e.g., sarcoma or lymphoma)

  • No Paget disease of the nipple

  • No skin involvement, regardless of tumor size

  • No distant metastases

  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Pre- or post-menopausal
  • ECOG performance status 0-1
  • No co-existing medical condition that would limit life expectancy to < 2 years
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except for nonmelanoma skin cancer (the disease-free interval from any prior malignancy must be continuous)
  • No collagen vascular disease, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
  • No psychiatric or addictive disorder that would preclude obtaining informed consent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • No prior radiotherapy for the current breast cancer

  • No tylectomies so extensive that the cosmetic result is low or poor prior to radiotherapy

  • Chemotherapy allowed provided the following criteria are met:

    • Chemotherapy is not administered prior to, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving brachytherapy boost)
    • Chemotherapy is not administered for ≥ 21 days before, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving external beam radiotherapy boost or chest wall irradiation)

  • Concurrent tamoxifen, anastrozole, or other hormonal therapy allowed

    • May be initiated before, during, or after radiotherapy

  • No other concurrent chemotherapy, immunotherapy, or experimental medications

Locations

FACILITYZIPCITYSTATE
RWJBarnabas Health - Robert Wood Johnson University Hospital08690HamiltonNew Jersey
RWJBarnabas Health - Robert Wood Johnson University Hospital08690New BrunswickNew Jersey
Rutgers Cancer Institute of New Jersey08903New BrunswickNew Jersey
RWJBarnabas Health - Robert Wood Johnson University Hospital08873SomersetNew Jersey

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