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

Primary Purpose

Breast Cancer, Ductal Carcinoma in Situ

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mammosite ML
Mammosite ML
Sponsored by
Mercy Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mercy Clinic St. Louis Cancer and Breast Institute
  • Mercy Hospital St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sole method

Boost

Arm Description

patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cosmetic Results
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 Measured Through Adverse Event Incidence
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.

Full Information

First Posted
September 30, 2011
Last Updated
June 25, 2021
Sponsor
Mercy Research
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1. Study Identification

Unique Protocol Identification Number
NCT01448447
Brief Title
Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®
Acronym
Mammosite ML
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Ductal Carcinoma in Situ

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sole method
Arm Type
Experimental
Arm Description
patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS
Arm Title
Boost
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Mammosite ML
Other Intervention Name(s)
HDR Brachytherapy
Intervention Description
34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days
Intervention Type
Device
Intervention Name(s)
Mammosite ML
Other Intervention Name(s)
HDR Brachytherapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Ipsilateral Recurrence Rate
Description
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Cosmetic Results
Description
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
Time Frame
6 months after treatment, then annually for 5 years
Title
Toxicity Measured Through Adverse Event Incidence
Description
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.
Time Frame
during therapy, 6 weeks after completion of therapy, and additionally as needed

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bethany G Sleckman, MD
Organizational Affiliation
Mercy Hospital St. Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Clinic St. Louis Cancer and Breast Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63011
Country
United States
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States

12. IPD Sharing Statement

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

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