Mammosite Breast Brachytherapy Optimization in the Treatment of Breast Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joanne Weidhaas, Yale University
ClinicalTrials.gov Identifier:
NCT00611624
First received: January 29, 2008
Last updated: April 5, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine if Mammosite Catheter optimization using multiple dwell position delivery decreases skin toxicity over historically reported skin toxicity with the single dwell delivery method.


Condition Intervention Phase
Breast Neoplasms
Radiation: Mammosite brachytherapy radiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Mammosite Breast Brachytherapy Optimization in the Treatment of Stage 0, I and II Breast Carcinoma

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Evaluation of skin toxicity the first year following treatment with the multiple dwell Mammosite delivery method [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Information of treatment parameters in order to define parameters most predictive of skin toxicity [ Time Frame: Upon completion of study ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2006
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Five Days of Mammosite Therapy
Five Days of Mammosite Therapy (Radiotherapy)
Radiation: Mammosite brachytherapy radiation
Treatment using MammoSite will begin within five days of placement of the catheter. Only high dose rate (HDR) with Ir-192 treatment is allowed. The balloon will remain inflated throughout the treatment course. A total of 34 Gy will be prescribed to an approximate 1 cm radial distance from the balloon surface. Two fractions per day, each of 3.4 Gy, separated by at least 6 hours, given on 5 treatment days (over a period of 5 to 10 days), will sum to 10 fractions and 34 Gy.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines.
  • Patient must be > 50 years old.
  • The patient should have a life expectancy of at least two years.
  • The patient must have stage 0 , I , or II breast cancer. If stage IIA, the tumor size must be 3 cm or less and the patients must be node negative.
  • On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
  • Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted.
  • Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.)
  • Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). (Axillary staging is NOT required for patients with DCIS.)
  • The patient must have the MammoSite catheter placed within 4 weeks or 28 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure). Placement of a spacer for the MammoSite catheter is permitted at their final surgery.
  • Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to randomization. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. Patients with a prior diagnosis of ipsilateral breast cancer are ineligible.
  • Chemotherapy is permitted if planned for >2 weeks after removal of Mammosite catheter.
  • Patient must be ineligible or have refused enrollment on the randomized trial RTOG (Radiation Therapy Oncology Group) 0413.

Exclusion Criteria:

  • Men are not eligible for this study.
  • T2 (>3.0 cm), T3, node positive, stage III or IV breast cancer.
  • Any positive axillary nodes.
  • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.
  • Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign.
  • Non-epithelial breast malignancies such as sarcoma or lymphoma.
  • Proven multicentric carcinoma in more than one quadrant or separated by more than 3 centimeters.
  • Paget's disease of the nipple.
  • History of invasive breast cancer or DCIS in the same breast.
  • Surgical margins that cannot be microscopically assessed or are less then 2 mm.
  • Collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.
  • Pregnancy or lactation at the time of proposed radiation. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
  • Patients with coexisting medical conditions in whom life expectancy is < 2 years.
  • Patients with skin involvement, regardless of tumor size.
  • Patients for whom treatment with the MammoSite catheter is not feasible, such as those with too little breast tissue between the skin and the catheter (as determined by distance of dose calculations).
  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: NCT00611624

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Joanne Weidhaas, M.D., Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Joanne Weidhaas, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00611624     History of Changes
Other Study ID Numbers: 0601000957
Study First Received: January 29, 2008
Last Updated: April 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
MammoSite
brachytherapy

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

ClinicalTrials.gov processed this record on October 23, 2014