Radiation Therapy in Treating Patients With Recurrent Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00945061
First received: July 22, 2009
Last updated: February 5, 2014
Last verified: February 2014

July 22, 2009
February 5, 2014
September 2008
April 2014   (final data collection date for primary outcome measure)
  • Ipsilateral breast tumor recurrence rates [ Time Frame: Every three months during the first year and every 6 months thereafter for 5 years. ] [ Designated as safety issue: No ]
  • Tumor bed recurrence rates [ Time Frame: Every three months during the first year and every 6 months thereafter for 5 years. ] [ Designated as safety issue: No ]
  • Cosmetic outcome as determined by an established scale [ Time Frame: 1 month after RT & Q3mos for one year and at 5 years ] [ Designated as safety issue: No ]
  • Patient satisfaction with the procedure as determined by a patient questionnaire [ Time Frame: one month post-radiation therapy, and every three months thereafter for one year, followed bi-annually for the remainder of the 5 year follow-up. ] [ Designated as safety issue: No ]
  • Wound healing and overall complication rate [ Time Frame: one month post-radiation therapy, and every three months thereafter for one year, followed bi-annually for the remainder of the 5 year follow-up. ] [ Designated as safety issue: No ]
  • Ipsilateral breast tumor recurrence rates [ Designated as safety issue: No ]
  • Tumor bed recurrence rates [ Designated as safety issue: No ]
  • Cosmetic outcome as determined by an established scale [ Designated as safety issue: No ]
  • Patient satisfaction with the procedure as determined by a patient questionnaire [ Designated as safety issue: No ]
  • Wound healing and overall complication rate [ Designated as safety issue: No ]
  • Determination of which patients are best suited for each individual technique of performing partial breast irradiation [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00945061 on ClinicalTrials.gov Archive Site
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Radiation Therapy in Treating Patients With Recurrent Breast Cancer
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

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.

OBJECTIVES:

  • To determine the in breast recurrence rate following repeat radiation to the breast with Mammosite® brachytherapy or intraoperative radiotherapy in patients with recurrent ipsilateral breast cancer.
  • 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 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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Radiation: intracavitary balloon brachytherapy
    Patients undergo brachytherapy
  • Radiation: intraoperative radiation therapy
    Patients undergo radiotherapy
  • Experimental: Group 1
    Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
    Intervention: Radiation: intraoperative radiation therapy
  • Experimental: Group 2
    Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
    Intervention: Radiation: intracavitary balloon brachytherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
Not Provided
April 2014   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast (ductal, medullary, papillary, colloid [mucinous], or tubular) meeting the following criteria:

    • 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 ≥ a 2 mm margin from invasive and in situ cancer or a negative re-excision
  • Patients with clinically and radiographically negative axillas should not undergo an axillary lymph node dissection unless they did not have prior axillary lymph node sampling (i.e., previous cancer was DCIS)
  • No invasive lobular carcinoma, extensive lobular carcinoma in situ, extensive DCIS (≥ 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma
  • 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 or cytologically confirmed negative
  • No extensive intraductal component by the Harvard definition, i.e., more than 25% of the invasive tumor is DCIS and DCIS present in adjacent breast tissue
  • No distant metastatic disease
  • No Paget's disease of the nipple
  • No skin involvement
  • No known BRCA1/BRCA2 mutations
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • No collagen vascular disorders, i.e., systemic lupus erythematosus, scleroderma, or dermatomyositis
  • No psychiatric, neurologic, or addictive disorders that would preclude study participation
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 5 years since prior radiotherapy
  • No chemotherapy within 2 weeks after completion of radiotherapy
  • Concurrent hormonal therapy allowed
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00945061
CASE11107, P30CA043703, CASE11107, CASE-11107-CC479
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Janice Lyons, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP