Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer

Early Phase 1CompletedNCT00527293

Case Comprehensive Cancer Center29 enrolled

Overview

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.

OBJECTIVES: * To determine the cosmetic outcome resulting from partial breast irradiation using two different techniques. * To determine patient satisfaction with partial breast irradiation as it pertains to their overall treatment experience as measured by a questionnaire. * To determine if there are patient factors that limit a patient's suitability to receive partial breast irradiation delivered by a particular technique. * To evaluate wound healing and overall complication rate after partial breast irradiation. * To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates. OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days. After completion of study therapy, patients are followed periodically for up to 5 years.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

adjuvant therapyPROCEDURE

If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.

3-dimensional conformal radiation therapyRADIATION

3-dimensional conformal radiotherapy twice daily for 5-10 days.

brachytherapyRADIATION

Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer, including the following histologic subtypes: * Invasive ductal carcinoma * Medullary ductal carcinoma * Papillary ductal carcinoma * Colloid (mucinous) ductal carcinoma * Tubular ductal carcinoma * The following histologic subtypes are not allowed: * Invasive lobular carcinoma * Extensive lobular carcinoma in situ * Ductal carcinoma in situ (DCIS) * Nonepithelial breast malignancies, such as lymphoma or sarcoma * No extensive intraductal component by Harvard definition (i.e., more than 25% of the invasive tumor is DCIS or DCIS present in adjacent tissue) * Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a) * Lesion ≤ 3 cm * No more than 3 positive lymph nodes * Patients with 4 or more positive axillary lymph nodes found at the time of axillary lymph node dissection/sentinel lymph node biopsy are not eligible * Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy) * Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR a negative re-excision margin * Unifocal breast cancer * No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm) * No palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative * No skin involvement of disease * No Paget's disease of the nipple * No distant metastatic disease * Hormone-receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Not pregnant or lactating * Negative pregnancy test * Fertile patients must use effective contraception for ≥ 1 week prior to, during, and for ≥ 2 weeks after completion of study treatment * No collagen vascular disorders, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis * No psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent * No other malignancy within the past 5 years, except non-melanomatous skin cancer PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the breast * No chemotherapy for at least 2 weeks before and 2 weeks after completion of study radiotherapy * Concurrent hormonal therapy allowed

Locations (4)

Lake/University Ireland Cancer Center

Cleveland, Ohio, United States

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, United States

UHHS Westlake Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon

Time frame: 1 month after RT & Q3mos for one year

Patient satisfaction with partial breast irradiation as measured by a questionnaire

Time frame: Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr

Wound healing and overall complication rate after partial breast irradiation

Time frame: 1 month after RT & Q3mos for one year

Determination of which patients are best suited for each individual technique of partial breast irradiation

Time frame: Patients will be followed for a period of five years following completion of radiation.

Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates

Time frame: Ipsilateral breast 6 mos after dx, bilateral annually x 5 years

Data from ClinicalTrials.gov

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