Clinical trial NCT00527293: Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer
Official title: Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
invasive ductal breast carcinoma
medullary ductal breast carcinoma with lymphocytic infiltrate
mucinous ductal breast carcinoma
tubular ductal breast carcinoma
papillary ductal breast carcinoma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-09-10
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon
timeFrame: 1 month after RT & Q3mos for one year
measure: Patient satisfaction with partial breast irradiation as measured by a questionnaire
timeFrame: Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr
measure: Wound healing and overall complication rate after partial breast irradiation
timeFrame: 1 month after RT & Q3mos for one year
measure: Determination of which patients are best suited for each individual technique of partial breast irradiation
timeFrame: Patients will be followed for a period of five years following completion of radiation.
measure: Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates
timeFrame: Ipsilateral breast 6 mos after dx, bilateral annually x 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Lake/University Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: UHHS Chagrin Highlands Medical Center
state: Ohio
city: Cleveland
country: United States
facility: UHHS Westlake Medical Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Janice Lyons, MD
role: STUDY_CHAIR
References: