Clinical trial · Interventional
Treatment of T1N0 Invasive Breast Carcinoma by Local Excision Implant
The Treatment of T1N0 Invasive Breast Carcinoma by Local Excision and Interstitial Implant
NCT00977275CI-TRIAL-00026910completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate radiation therapy directed to a small region of the breast in women who were recently diagnosed with early stage invasive breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interstitial Implant Brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine if interstitial implant brachytherapy to radical radiation doses is feasible following wide local excision of T1N0 breast carcinoma
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Low risk of multifocal disease within the breast whose tumor location is favorable for brachytherapy catheter placement * Diagnosis of invasive breast carcinoma (biopsy or fine needle aspiration cytology) and be clinical stage T1N0 (primary tumor \< 2cm, clinically negative nodes) * Location of primary tumor is not immediately adjacent to the nipple of chest wall * No evidence of two or more separate tumors within the breast * All histologic types and pathologic grades of primary tumor * No extensive intraductal component (substantial intraductal carcinoma away from the primary tumor location) * No lymphatic or vascular invasion * Lymph node staging by sentinel node excision or axillary dissection confirms node negative status (If node positive, implant is used to deliver boost to tumor bed) * Assessment of final surgical margins should be predominantly negative, but a single small region of focal positivity is allowable as it is for whole breast radiation * 18 years of age or older Exclusion Criteria: * Tumor is too close to the chest wall to allow placement of catheters * Contraindications to radiation therapy are present, including a history of scleroderma, systemic lupus or other active connective tissue disease, pregnancy, or prior chest wall radiation
References
Publications (2)
- RESULTHattangadi JA, Powell SN, MacDonald SM, Mauceri T, Ancukiewicz M, Freer P, Lawenda B, Alm El-Din MA, Gadd MA, Smith BL, Taghian AG. Accelerated partial breast irradiation with low-dose-rate interstitial implant brachytherapy after wide local excision: 12-year outcomes from a prospective trial. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):791-800. doi: 10.1016/j.ijrobp.2011.09.003. Epub 2011 Nov 16. PMID 22099046
- RESULTLawenda BD, Taghian AG, Kachnic LA, Hamdi H, Smith BL, Gadd MA, Mauceri T, Powell SN. Dose-volume analysis of radiotherapy for T1N0 invasive breast cancer treated by local excision and partial breast irradiation by low-dose-rate interstitial implant. Int J Radiat Oncol Biol Phys. 2003 Jul 1;56(3):671-80. doi: 10.1016/s0360-3016(03)00071-3. PMID 12788172