Clinical trial NCT00945061: Radiation Therapy in Treating Patients With Recurrent Breast Cancer
Official title: Partial Breast Re-Irradiation for Patients With Ipsilateral Breast Tumor Recurrence, After First Being Treated With Breast Conservation for Early Stage Breast Cancer: An Efficacy Trial Comparing Mammosite® and Intraoperative Radiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
recurrent breast cancer
invasive ductal breast carcinoma
medullary ductal breast carcinoma with lymphocytic infiltrate
mucinous ductal breast carcinoma
papillary ductal breast carcinoma
tubular ductal breast carcinoma
male breast cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.

PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.

Detailed description: OBJECTIVES:

* To determine the in breast recurrence rate following repeat radiation to the breast. These patients will be followed for a period of five years following completion of radiation to determine these rates.
* To determine the cosmetic outcome resulting from partial breast re-irradiation using different techniques, including both physician and patient rated scales.
* To determine patient satisfaction of partial breast re-irradiation as it pertains to their overall treatment experience, as measured by a questionnaire.
* To determine if there are patient factors illuminated during a discussion of informed consent, which limit a patient's suitability to receive partial breast re-irradiation delivered by a particular technique.
* To evaluate tylectomy wound healing and overall complication rate after partial breast re-irradiation.
* To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.These patients will be followed for a period of five years following completion of the second course of radiation to determine these rates.

OUTLINE: Patients are stratified according to which modality is best suited for the patient. Patients are assigned to 1 of 2 groups.

All patients undergo excisional biopsy or needle localization removal of the tumor. Patients with margins \< 2 mm undergo re-excision of the biopsy cavity.

* Group 1: Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
* Group 2: Patients undergo partial breast irradiation delivered by Mammosite® brachytherapy consisting of 10 fractions over 5 days.

Quality of life is assessed at baseline, 1 month after completion of radiotherapy, and then at follow-up visits.

After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 5 years.

Eligibility criteria: Inclusion Criteria:

* Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
* Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)
* Unifocal breast cancer recurrence
* Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision
* Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.
* Signed study-specific informed consent prior to study entry.

Exclusion Criteria:

* Patients with distant metastatic disease
* Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma.
* Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.
* Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is Ductal carcinoma in situ (DCIS) and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.
* Patients with Paget's disease of the nipple.
* Patients with skin involvement.
* Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
* Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.
* Other malignancy, except non-melanomatous skin cancer, \< 5 years prior to participation in this study.
* Patients who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.
* Patients with known BReast CAncer gene (BRCA)1/BRCA 2 mutations.

Primary outcomes:
measure: Ipsilateral Breast Tumor Recurrence Rates
timeFrame: 1 month after radiation therapy (RT)
measure: Ipsilateral Breast Tumor Recurrence Rates
timeFrame: 3 months after RT
measure: Ipsilateral Breast Tumor Recurrence Rates
timeFrame: 6 months after RT
measure: Ipsilateral Breast Tumor Recurrence Rates
timeFrame: 9 months after RT
measure: Ipsilateral Breast Tumor Recurrence Rates
timeFrame: 12 months after RT
measure: Ipsilateral Breast Tumor Recurrence Rates
timeFrame: 2 years after RT
measure: Ipsilateral Breast Tumor Recurrence Rates
timeFrame: 3 years after RT
measure: Ipsilateral Breast Tumor Recurrence Rates
timeFrame: 4 years after RT
measure: Ipsilateral Breast Tumor Recurrence Rates
timeFrame: 5 years after RT
measure: Tumor Bed Recurrence Rates
timeFrame: 1 month after RT
measure: Tumor Bed Recurrence Rates
timeFrame: 3 month after RT
measure: Tumor Bed Recurrence Rates
timeFrame: 6 month after RT
measure: Tumor Bed Recurrence Rates
timeFrame: 12 month after RT
measure: Tumor Bed Recurrence Rates
timeFrame: 2 years after RT
measure: Tumor Bed Recurrence Rates
timeFrame: 3 years after RT
measure: Tumor Bed Recurrence Rates
timeFrame: 4 years after RT
measure: Tumor Bed Recurrence Rates
timeFrame: 5 years after RT
measure: Cosmetic Outcome as Determined by an Established Scale
timeFrame: 1 month after RT & Q3mos for one year and at 5 years
measure: Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
timeFrame: 1 month after RT
measure: Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
timeFrame: 3 month after RT
measure: Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
timeFrame: 6 month after RT
measure: Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
timeFrame: 9 month after RT
measure: Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
timeFrame: 12 month after RT
measure: Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
timeFrame: 2 years after RT
measure: Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
timeFrame: 3 years after RT
measure: Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
timeFrame: 4 years after RT
measure: Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
timeFrame: 5 years after RT
measure: Percent of Participants Experiencing Complications After Intervention
timeFrame: 1 month after RT
measure: Percent of Participants Experiencing Complications After Intervention
timeFrame: 3 month after RT
measure: Percent of Participants Experiencing Complications After Intervention
timeFrame: 6 month after RT
measure: Percent of Participants Experiencing Complications After Intervention
timeFrame: 9 month after RT
measure: Percent of Participants Experiencing Complications After Intervention
timeFrame: 12 month after RT
measure: Percent of Participants Experiencing Complications After Intervention
timeFrame: 2 years after RT
measure: Percent of Participants Experiencing Complications After Intervention
timeFrame: 3 years after RT
measure: Percent of Participants Experiencing Complications After Intervention
timeFrame: 4 years after RT
measure: Percent of Participants Experiencing Complications After Intervention
timeFrame: 5 years after RT
Secondary outcomes:
measure: Percent of Participants With Delayed Wound Healing
timeFrame: 1 month after RT
measure: Percent of Participants With Delayed Wound Healing
timeFrame: 3 month after RT
measure: Percent of Participants With Delayed Wound Healing
timeFrame: 6 month after RT
measure: Percent of Participants With Delayed Wound Healing
timeFrame: 9 month after RT
measure: Percent of Participants With Delayed Wound Healing
timeFrame: 12 month after RT
measure: Percent of Participants With Delayed Wound Healing
timeFrame: 2 years after RT
measure: Percent of Participants With Delayed Wound Healing
timeFrame: 3 years after RT
measure: Percent of Participants With Delayed Wound Healing
timeFrame: 4 years after RT
measure: Percent of Participants With Delayed Wound Healing
timeFrame: 5 years after RT
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, 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: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
name: Janice Lyons, MD
role: PRINCIPAL_INVESTIGATOR
References: