Accelerated Whole Breast Radiotherapy in Treating Patients with Breast Cancer Who Have Undergone Surgery

Status: Active

Description

This phase II trial studies how well accelerate whole breast radiotherapy works in treating patients with breast cancer who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Ductal carcinoma in-situ or invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies; invasive lobular carcinomas are allowed
  • American Joint Committee on Cancer (AJCC) stage 0-IIIa (pathologic stage Tis, T1N0, T2N0, T1N1a, T2N1a, T1N2a, T2N2a, M0) histologically confirmed ductal carcinoma in-situ or invasive carcinoma of the breast with a lesion =< 5 cm treated with lumpectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
  • Unifocal or multifocal (confined to one quadrant, lesions less than 4 cm apart) breast cancer (1 or 2 foci which can be encompassed by one lumpectomy)
  • Negative inked histologic margins of lumpectomy (no invasive cells at margin) or negative re-excision specimen to be confirmed prior to radiation
  • Tamoxifen, Arimidex or other hormonal therapy is allowed; it may begin any time relative to the radiation at the discretion of the treating physician
  • Chemotherapy is allowed; if chemotherapy is indicated and brachytherapy boost is planned, it must be administered after the accelerated whole breast irradiation (AWBI) but should begin no earlier than 21 days following completion of radiation therapy; alternatively if chemotherapy is indicated and external beam boost is planned, the chemotherapy can be delivered first, followed by radiation therapy beginning 21-63 days after the last cycle of chemotherapy or the radiation therapy can be delivered first and the chemotherapy can be delivered no earlier than 21 days post radiation therapy
  • The patient must be enrolled and have treatment planning between 14-63 days from date of last surgery or last cycle of chemotherapy, and radiation must start within 21-63 days of date of last surgery or last cycle of chemotherapy
  • Signed study-specific informed consent form prior to study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

  • Evidence of suspicious microcalcifications in the breast prior to the start of radiation
  • Greater than 9 positive axillary nodes/sentinel biopsy
  • Patient with distant metastases
  • Patients with lobular carcinoma in-situ alone (no invasive component) and patients with non-epithelial breast malignancies such as sarcoma or lymphoma
  • Patients with proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
  • Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
  • Any previously treated contralateral breast carcinoma or synchronous ipsilateral breast carcinoma
  • Prior radiation therapy for the current breast cancer
  • For patients treated with external beam boost, prior chemotherapy if administered less than 3 weeks from start of radiation therapy or chemotherapy < 3 weeks after finishing radiation therapy; for patients treated with brachytherapy intracavitary device, chemotherapy prior to start of radiation therapy (RT)
  • Patients with Paget’s disease of the nipple
  • Patients with skin involvement, regardless of tumor size
  • Patients with a breast technically unsatisfactory for radiation therapy
  • Patients with tylectomies so extensive that the cosmetic result is low or poor prior to radiation
  • Patients with collagen vascular diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
  • Patients with co-existing medical conditions with life expectancy < 2 years
  • Patients with psychiatric or addictive disorders that would preclude obtaining informed consent
  • Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
  • Women who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females
  • Women who are able to conceive and unwilling to practice and effective method of birth control; women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to treatment

Locations & Contacts

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Contact: Bruce George Haffty
Phone: 732-235-3959
Email: hafftybg@cinj.rutgers.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Freedom from local failure and freedom from regional failure.

II. Acute toxicity and late toxicity using previously published toxicity scales.

SECONDARY OBJECTIVES:

I. Cosmesis using the Harvard cosmesis scale. Cosmesis will be assessed by the patient, by the treating physician, and documented by digital photography and reviewed by an independent nurse and a non-treating physician.

II. To identify co-variates responsible for poor cosmetic outcome in women treated with accelerated, hypofractionated radiotherapy.

III. To correlate toxicity, cosmesis, and local control with genomic profiles.

OUTLINE:

Patients undergo accelerated, hypofractionated whole breast radiotherapy once daily (QD) 5 days per week for a total of 11 fractions followed by 3-dimensional conformal radiation therapy (3DCRT)/intensity-modulated radiation therapy (IMRT) lumpectomy bed boost QD 5 days per week for a total of 4 fractions (the order of accelerated, hypofractionated whole breast radiotherapy and 3DCRT/IMRT lumpectomy bed boost may be reversed).

After completion of study treatment, patients are followed up at 2-8 weeks and then every 6-12 months for 5 years.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Rutgers Cancer Institute of New Jersey

Principal Investigator
Bruce George Haffty

Trial IDs

Primary ID 040807
Secondary IDs NCI-2012-00535, CDR0000643276
Clinicaltrials.gov ID NCT00909909