Clinical trial · Interventional
Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
Standardization of Breast Radiotherapy: Trial B - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer
NCT00005587CI-TRIAL-00013109completedPhase 3ClinicalTrials.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 uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective following surgery for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of radiation therapy following surgery in treating women who have early stage 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 |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed invasive unilateral breast cancer * T1-3, N0-1, M0 at presentation * Complete macroscopic excision of tumor by breast conserving surgery or mastectomy * No immediate breast reconstruction * No requirement for axillary radiotherapy after greater than a Level 1 axillary dissection or after greater than 10 lymph nodes have been removed * Not enrolled on SECRAB or OSCAR trials * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified PRIOR CONCURRENT THERAPY: * Prior neoadjuvant, or primary medical, therapy is allowed provided subsequent surgery confirms complete macroscopic excision of residual primary tumor Biologic therapy: * Not specified Chemotherapy: * At least 2 weeks since prior cytotoxic agents * No concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics
References
Publications (4)
- RESULTHopwood P, Haviland JS, Sumo G, Mills J, Bliss JM, Yarnold JR; START Trial Management Group. Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised Standardisation of Breast Radiotherapy (START) trials. Lancet Oncol. 2010 Mar;11(3):231-40. doi: 10.1016/S1470-2045(09)70382-1. Epub 2010 Feb 6. PMID 20138809
- RESULTSTART Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet. 2008 Mar 29;371(9618):1098-107. doi: 10.1016/S0140-6736(08)60348-7. Epub 2008 Mar 19. PMID 18355913
- RESULTHopwood P, Haviland J, Mills J, Sumo G, M Bliss J; START Trial Management Group. The impact of age and clinical factors on quality of life in early breast cancer: an analysis of 2208 women recruited to the UK START Trial (Standardisation of Breast Radiotherapy Trial). Breast. 2007 Jun;16(3):241-51. doi: 10.1016/j.breast.2006.11.003. Epub 2007 Jan 19. PMID 17236771
- RESULTVenables K, Miles EA, Aird EG, Hoskin PJ; START Trial Management Group. The use of in vivo thermoluminescent dosimeters in the quality assurance programme for the START breast fractionation trial. Radiother Oncol. 2004 Jun;71(3):303-10. doi: 10.1016/j.radonc.2004.02.008. PMID 15172146