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Completed

NCT Number: NCT01448447

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

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.

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mercy Clinic St. Louis Cancer and Breast Institute, St Louis, Missouri, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: HDR Brachytherapy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Mercy Research

Other

Registry information

Official study 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

Acronym: Mammosite ML

Important dates

Study start
2009
Primary completion
2015
Study completion
2016
First posted
Oct 7, 2011
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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