N/A
N=20
Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®
Breast Cancer · Ductal Carcinoma in Situ
Bottom Line
View on ClinicalTrials.gov: NCT01448447 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Ipsilateral Recurrence Rate — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mammosite ML (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Mercy Research
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ipsilateral Recurrence Rate |
— | — |
| SECONDARY Cosmetic Results |
4; 0; 14; 0; 0; 0 | — |
| SECONDARY Toxicity Measured Through Adverse Event Incidence |
0; 0 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT01448447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.