Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml® (Mammosite ML)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by St. John's Mercy Research Institute, St. Louis
Sponsor:
Information provided by (Responsible Party):
Bethany Sleckman, St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier:
NCT01448447
First received: September 30, 2011
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

This study will evaluate the local control rate, cosmetic results, and complication rates of breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of radiation therapy or as a boost technique for patients with stage I-II carcinoma of the breast (< 3 cm), (non-lobular histology) treated with lumpectomy with histologically negative surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS.

Hypotheses:

  • For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS), radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is technically feasible and reproducible with acceptable complication rates.
  • Cosmetic results after brachytherapy will be similar to that obtained after traditional whole breast external beam radiation therapy.
  • Local tumor control rate in the breast after brachytherapy will be similar to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.

Condition Intervention Phase
Breast Cancer
Ductal Carcinoma in Situ
Device: Mammosite ML
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml® Radiation Therapy Delivery System as the Sole Method of Radiation Therapy or as a Boost for Early Stage Breast Cancer and Ductal Carcinoma In Situ of the Breast

Resource links provided by NLM:


Further study details as provided by St. John's Mercy Research Institute, St. Louis:

Primary Outcome Measures:
  • ipsilateral recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    • Local recurrence is defined as either invasive or non-invasive breast cancer recurrence within the target volume.
    • Elsewhere recurrence is defined as either invasive or non-invasive breast cancer recurrence outside of the target volume.
    • Local control rate will be evaluated by imaging techniques, physical exam and biopsy, if applicable.


Secondary Outcome Measures:
  • cosmetic results [ Time Frame: 6 months after treatment, then annually for 5 years ] [ Designated as safety issue: No ]
    Evaluation of cosmetic results as judged by the patient, surgeon, and radiation oncologist at stated follow up intervals. Serial photographs will be obtained. The cosmetic results will be assessed using the four category Harvard Scale definitions: Excellent - The treated breast looks essentially the same as the opposite breast Good - Minimal but identifiable effects of radiation on the treated breast Fair - Significant effects of radiation on the treated breast Poor - Severe normal tissue sequelae secondary to irradiation

  • toxicity [ Time Frame: during therapy, 6 weeks after completion of therapy, and additionally as needed ] [ Designated as safety issue: Yes ]
    The incidence of serious adverse events will be calculated.


Estimated Enrollment: 200
Study Start Date: December 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sole method
patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS
Device: Mammosite ML
34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days
Other Name: HDR Brachytherapy
Experimental: Boost
patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS
Device: Mammosite ML
5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)
Other Name: HDR Brachytherapy

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women,age of at least 45 years
  • Zubrod performance status of 0-2
  • AJCC Stage I-II (T1-T2, N0 M0) breast cancer
  • Maximum tumor dimension < 3 cm
  • Invasive ductal, medullary, papillary, tubular, colloid (mucinous) histologies
  • Unifocal breast cancer
  • Unilateral breast cancer (no synchronous or previous contralateral breast cancer)
  • Lumpectomy with negative surgical margins by at least 2 mm or re-excision specimen with negative surgical margins by at least 2 mm
  • Ductal Carcinoma In-Situ
  • Negative axillary lymph nodes for invasive breast cancer (sentinel node biopsy or standard level I-II dissection with > 6 nodes removed)
  • Time interval from final breast surgery to brachytherapy loading less than 8 weeks
  • At least 2 mm of breast tissue between the skin and the MammoSite® balloon surface(prefer > 5 mm)
  • If chemotherapy is planned, it must begin no earlier that 2 weeks following completion of radiation therapy. If chemotherapy is first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation therapy.
  • Signed study-specific consent form

Exclusion Criteria:

  • Invasive lobular histology
  • Non-epithelial breast malignancies such as sarcoma or lymphoma
  • Multifocal or multicentric invasive carcinoma
  • Extensive intraductal component (EIC)
  • Paget's disease of the nipple
  • Skin involvement by tumor, regardless of tumor size
  • Positive axillary lymph nodes
  • Distant metastases
  • Collagen vascular disease (scleroderma)
  • Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females (negative pregnancy test for women of child-bearing age)
  • Any previously treated or synchronous contralateral breast carcinoma
  • Patients with psychiatric or addictive disorder that would preclude obtaining informed Consent
  • Men
  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: NCT01448447

Contacts
Contact: Kathy Baglan, MD kathy.baglan@mercy.net
Contact: Julie Mai, MD julie.mai@mercy.net

Locations
United States, Missouri
Mercy Hospital St. Louis Recruiting
St. Louis, Missouri, United States, 63141
Mercy Clinic St. Louis Cancer and Breast Institute Recruiting
St. Louis, Missouri, United States, 63011
Sponsors and Collaborators
St. John's Mercy Research Institute, St. Louis
Investigators
Principal Investigator: Bethany G Sleckman, MD Mercy Hospital St. Louis
  More Information

No publications provided

Responsible Party: Bethany Sleckman, Director of Oncology Research, St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier: NCT01448447     History of Changes
Other Study ID Numbers: Mammosite ML
Study First Received: September 30, 2011
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Breast Neoplasms
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014