Clinical trial · Interventional
Breast-Conserving Surgery and Whole-Breast Radiation Therapy With or Without Additional Radiation Therapy to the Tumor in Treating Women With Ductal Carcinoma in Situ (BONBIS)
A Multicentric Phase III Trial Evaluating the Impact of a Radiation Boost (16Gy) After Breast Conserving Surgery and a Whole Breast Irradiation (50Gy) for DCIS
NCT00907868CI-TRIAL-00102571BONBISactive not recruitingN/AClinicalTrials.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 kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether whole-breast radiation therapy is more effective when given with or without additional radiation therapy to the tumor in treating patients with ductal carcinoma in situ. PURPOSE: This randomized phase III trial is studying breast-conserving surgery followed by whole-breast radiation therapy to see how well it works when given with or without additional radiation therapy to the tumor in treating women with ductal carcinoma in situ.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| partial breast irradiation | Radiation | — | UNRESOLVED |
| whole breast irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients undergo whole breast irradiation (WBI) once daily for 5 weeks (weekdays only).
- interventionNames
- Radiation: whole breast irradiation
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo WBI as in arm I and a radiation tumor bed boost once daily for 8 days (weekdays only).
- interventionNames
- Radiation: partial breast irradiation
- Radiation: whole breast irradiation
Primary outcomes (1)
- measure
- Time to recurrence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed ductal carcinoma in situ of the breast * No invasive component * No clinically palpable lymph node or presence of tumor cells in the sentinel lymph node (if done) * No local recurrence of a primary breast cancer * No multicentric or multifocal tumors not suitable for conservative surgery R0 with a margin ≥ 1 mm * Has undergone bilateral mammography within 6 months before randomization PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 5 years * Not pregnant * Available for long-term follow up * No history of in situ carcinoma in the contralateral breast * No history of another cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix * No uncontrolled cardiac, renal, or pulmonary disease * No uncontrolled systemic disease (e.g., lupus erythematosus or scleroderma) * No HIV positivity * Affiliated with the social health system * No psychological, familial, sociological, or geographical situations that preclude compliance with study treatment and follow up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent participation in another therapeutic trial (participation in epidemiologic studies is allowed)
References
Publications (19)
- BACKGROUNDAzria D, Gourgou S, Sozzi WJ, Zouhair A, Mirimanoff RO, Kramar A, Lemanski C, Dubois JB, Romieu G, Pelegrin A, Ozsahin M. Concomitant use of tamoxifen with radiotherapy enhances subcutaneous breast fibrosis in hypersensitive patients. Br J Cancer. 2004 Oct 4;91(7):1251-60. doi: 10.1038/sj.bjc.6602146. PMID 15328527
- BACKGROUNDBartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18. PMID 17577015
- BACKGROUNDEORTC Breast Cancer Cooperative Group; EORTC Radiotherapy Group; Bijker N, Meijnen P, Peterse JL, Bogaerts J, Van Hoorebeeck I, Julien JP, Gennaro M, Rouanet P, Avril A, Fentiman IS, Bartelink H, Rutgers EJ. Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853--a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol. 2006 Jul 20;24(21):3381-7. doi: 10.1200/JCO.2006.06.1366. Epub 2006 Jun 26. PMID 16801628
- BACKGROUNDBijker N, Peterse JL, Duchateau L, Julien JP, Fentiman IS, Duval C, Di Palma S, Simony-Lafontaine J, de Mascarel I, van de Vijver MJ. Risk factors for recurrence and metastasis after breast-conserving therapy for ductal carcinoma-in-situ: analysis of European Organization for Research and Treatment of Cancer Trial 10853. J Clin Oncol. 2001 Apr 15;19(8):2263-71. doi: 10.1200/JCO.2001.19.8.2263. PMID 11304780
- BACKGROUNDCutuli B, Cohen-Solal-le Nir C, de Lafontan B, Mignotte H, Fichet V, Fay R, Servent V, Giard S, Charra-Brunaud C, Lemanski C, Auvray H, Jacquot S, Charpentier JC. Breast-conserving therapy for ductal carcinoma in situ of the breast: the French Cancer Centers' experience. Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):868-79. doi: 10.1016/s0360-3016(02)02834-1.