Clinical trial · Interventional
Randomized Boost Versus no Boost Irradiation of Early Breast Cancer
Phase III Study in the Conservative Management of Breast Carcinoma by Tumorectomy and Radiotherapy: Assessment of the Role of a Booster Dose of Radiotherapy (Joint Study of the European Organisation for Research and Treatment of Cancer Radiotherapy Cooperative Group and Breast Cancer Cooperative Group)
- 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)
Radiation therapy may kill any tumor cells remaining after surgery. This randomized phase III trial is studying the effect of an extra dose of radiation therapy (Boost dose) after breast conserving surgery and 50 Gy adjuvant external beam radiotherapy to see how well it works compared to no further therapy in treating women with early breast cancer that has been surgically removed.
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 |
|---|---|---|---|
| Boost irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Boost irradiation
- interventionNames
- Radiation: Boost irradiation
- type
- NO_INTERVENTION
- label
- No boost irradiation
Primary outcomes (1)
- measure
- Time to local recurrence
- timeFrame
- 25 years from first patient in
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented invasive adenocarcinoma (any subtype) of the breast with clinical stage T1-2 (0-5 cm) and pathologic stage N0-1, M0 disease * Lumpectomy with 1-2 cm margin required within 9 weeks of initiation of protocol radiotherapy * Axillary dissection required for premenopausal patients and recommended for postmenopausal patients (Irradiation of clinically negative axilla is an acceptable alternative to axillary dissection in postmenopausal patients) Exclusion Criteria: * Residual microcalcification on postoperative mammogram * Gross residual disease in the breast (re-excision allowed if there is gross residual disease after first surgical procedure) * Multiple foci of tumor in more than 1 quadrant * Previous or concurrent malignant tumor in contralateral breast * In situ carcinoma of the breast, without invasive tumor * Tumorectomy performed more than 9 weeks before the start of radiotherapy in cases where no adjuvant chemotherapy is given and more than 6 months before the start of radiotherapy if chemotherapy is given * Previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin * Concurrent pregnancy or lactation * Eastern Cooperative Oncology Group performance scale more than 2
References
Publications (2)
- DERIVEDVrieling C, van Werkhoven E, Maingon P, Poortmans P, Weltens C, Fourquet A, Schinagl D, Oei B, Rodenhuis CC, Horiot JC, Struikmans H, Van Limbergen E, Kirova Y, Elkhuizen P, Bongartz R, Miralbell R, Morgan DA, Dubois JB, Remouchamps V, Mirimanoff RO, Hart G, Collette S, Collette L, Bartelink H; European Organisation for Research and Treatment of Cancer, Radiation Oncology and Breast Cancer Groups. Prognostic Factors for Local Control in Breast Cancer After Long-term Follow-up in the EORTC Boost vs No Boost Trial: A Randomized Clinical Trial. JAMA Oncol. 2017 Jan 1;3(1):42-48. doi: 10.1001/jamaoncol.2016.3031. PMID 27607734
- DERIVEDBartelink H, Maingon P, Poortmans P, Weltens C, Fourquet A, Jager J, Schinagl D, Oei B, Rodenhuis C, Horiot JC, Struikmans H, Van Limbergen E, Kirova Y, Elkhuizen P, Bongartz R, Miralbell R, Morgan D, Dubois JB, Remouchamps V, Mirimanoff RO, Collette S, Collette L; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial. Lancet Oncol. 2015 Jan;16(1):47-56. doi: 10.1016/S1470-2045(14)71156-8. Epub 2014 Dec 9. PMID 25500422