Clinical trial · Interventional
Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer
A PHASE I/II TRIAL TO EVALUATE BRACHYTHERAPY AS THE SOLE METHOD OF RADIATION THERAPY FOR STAGE I AND II BREAST CARCINOMA
NCT00002873CI-TRIAL-00011436completedPhase 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)
RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery. PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating women who have stage I or stage II 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 |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed nonlobular invasive breast cancer of one of the following histologies: Ductal Papillary Medullary Colloid (mucinous) Tubular Stage I/II (T1-2 N0-1 M0) tumor no greater than 3 cm Prior tylectomy and axillary lymph node dissection required No more than 3 positive axillary lymph nodes and no extracapsular extension At least 6 lymph nodes sampled OR Negative sentinal node Surgical clips in place delineating margins of tylectomy cavity Negative, or close but negative, inked histologic margins of tylectomy or re-excision specimen Negative margins defined as no tumor at least 2 mm away from the inked margins Close but negative margins defined as tumor within 2 mm of inked margin Positive margins defined as invasive or noninvasive tumor at inked resection margins Negative post-tylectomy or post-reexcision mammogram required if disease presented with malignancy-associated microcalcifications No remaining suspicious microcalcifications If catheters are placed at time of reexcision, the crieria may not be feasible but a post brachytherapy mammogram should be obtained as soon as possible No extensive intraductal carcinoma by the Harvard definition, i.e.: More than 25% of tumor is ductal carcinoma in situ (DCIS) and there is DCIS in adjacent breast tissue OR Intraductal carcinoma with microinvasion No proven multicentric carcinoma, i.e.: Tumor in different quadrants of the breast OR Tumor separated by at least 4 cm The following exclude: Skin or chest wall invasion Matted or fixed axillary adenopathy Metastatic internal mammary or supraclavicular nodes Paget's disease of the nipple Previously treated contralateral breast carcinoma or synchronous bilateral breast carcinoma Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Not specified Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No collagen vascular disease with a c-reactive protein level above normal or with an active skin rash (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis) No coexisting medical condition that reduces life expectancy to less than 2 years No second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for breast cancer Planned chemotherapy may begin at least 2 weeks after removal of brachytherapy catheters Endocrine therapy: Concurrent tamoxifen permitted Radiotherapy: No prior radiotherapy for breast cancer Surgery: See Disease Characteristics
References
Publications (5)
- RESULTArthur DW, Winter K, Kuske RR, Bolton J, Rabinovitch R, White J, Hanson WF, Wilenzick RM, McCormick B. A Phase II trial of brachytherapy alone after lumpectomy for select breast cancer: tumor control and survival outcomes of RTOG 95-17. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):467-73. doi: 10.1016/j.ijrobp.2007.12.056. Epub 2008 Mar 4. PMID 18294778
- RESULTIbbott GS, Hanson WF, O'Meara E, Kuske RR, Arthur D, Rabinovitch R, White J, Wilenzick RM, Harris I, Tailor RC. Dose specification and quality assurance of radiation therapy oncology group protocol 95-17; a cooperative group study of iridium-192 breast implants as sole therapy. Int J Radiat Oncol Biol Phys. 2007 Dec 1;69(5):1572-8. doi: 10.1016/j.ijrobp.2007.08.011. PMID 18035213
- RESULTRabinovitch R, Winter K, Kuske R, Bolton J, Arthur D, Scroggins T, Vicini F, McCormick B, White J. RTOG 95-17, a Phase II trial to evaluate brachytherapy as the sole method of radiation therapy for Stage I and II breast carcinoma--year-5 toxicity and cosmesis. Brachytherapy. 2014 Jan-Feb;13(1):17-22. doi: 10.1016/j.brachy.2013.08.002. Epub 2013 Sep 14. PMID 24041956
- RESULTKuske RR, Winter K, Arthur DW, et al.: A phase II trial of brachytherapy alone following lumpectomy for stage I or II breast cancer: initial outcomes of RTOG 9517. [Abstract] J Clin Oncol 22 (Suppl 14): A-565, 18s, 2004.
- RESULTKuske RR, Winter K, Arthur D, et al.: A phase I/II trial of brachytherapy alone following lumpectomy for select breast cancer: toxicity analysis of Radiation Therapy Oncology Group 95-17. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): A-151, 87, 2002.