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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: intracavitary balloon brachytherapy
Radiation: intraoperative radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: September 2008
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Radiation: intraoperative radiation therapy
Patients undergo radiotherapy
Experimental: Group 2
Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
Radiation: intracavitary balloon brachytherapy
Patients undergo brachytherapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945061

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122
UHHS Westlake Medical Center
Cleveland, Ohio, United States, 44145
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Janice Lyons, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00945061     History of Changes
Other Study ID Numbers: CASE11107, P30CA043703, CASE11107, CASE-11107-CC479
Study First Received: July 22, 2009
Last Updated: February 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014