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

June 25, 2021 updated by: Robert Frazier, MD, Mercy Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital St. Louis
      • Saint Louis, Missouri, United States, 63011
        • Mercy Clinic St. Louis Cancer and Breast Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • HDR Brachytherapy
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 Names:
  • 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
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 Names:
  • HDR Brachytherapy
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 Names:
  • HDR Brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ipsilateral Recurrence Rate
Time Frame: 5 years
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmetic Results
Time Frame: 6 months after treatment, then annually for 5 years
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
6 months after treatment, then annually for 5 years
Toxicity Measured Through Adverse Event Incidence
Time Frame: during therapy, 6 weeks after completion of therapy, and additionally as needed
The incidence of serious adverse events will be calculated. Adverse events reviewed for device harm/toxicity include skin redness, breast pain, infections, breast swelling, and rib fractures.
during therapy, 6 weeks after completion of therapy, and additionally as needed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercy Research

Investigators

  • Principal Investigator: Bethany G Sleckman, MD, Mercy Hospital St. Louis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

September 30, 2011

First Submitted That Met QC Criteria

October 5, 2011

First Posted (ESTIMATE)

October 7, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mammosite ML

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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