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

NCT01448447 | Completed Results

• 1 other identifier: Mammosite ML
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer; Ductal Carcinoma in Situ

Outcome Measures

Primary Outcomes (1)

• Ipsilateral Recurrence Rate

  * 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. Measured as a count of participants experiencing recurrence, i.e. each subject experiencing ipsilateral tumor recurrence within 5 years = 1, and each subject with no ipsilateral tumor recurrence within 5 years = 0

  5 years

Secondary Outcomes (2)

• Cosmetic Results

  6 months after treatment, then annually for 5 years

• Toxicity Measured Through Adverse Event Incidence

  during therapy, 6 weeks after completion of therapy, and additionally as needed

Study Arms (2)

Sole method

EXPERIMENTAL

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

Boost

EXPERIMENTAL

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

Interventions

Mammosite ML DEVICE

34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days

Also known as: HDR Brachytherapy

Sole method

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Research: lead

Study Sites (2)

Mercy Clinic St. Louis Cancer and Breast Institute

St Louis, Missouri, 63011, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

• Title: Dr. Robert Frazier
• Organization: Mercy

Robert.Frazier@mercy.net

314-251-6844

Study Officials

• Bethany G Sleckman, MD

  Mercy Hospital St. Louis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Radiation Oncologist

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 7, 2011
• Study Start: December 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: July 15, 2021
• Results First Posted: July 15, 2021

Record last verified: 2021-06

Locations

US (2)