Clinical trial · Interventional
Intensity Modulated Radiotherapy for Breast Cancer
Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study
NCT00594477CI-TRIAL-00029020IMRTcompletedPhase 1ClinicalTrials.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)
This study delivers radiation therapy to any residual breast tissue and the chest wall plus lymph node areas around the breast. These lymph node areas are under the arm, around the collar bone, and under the sternum (breastbone).
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 |
|---|---|---|---|
| IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT
- description
- The prescribed dose for all patients will be 5040 cGy in 28 fractions. Patients will receive external beam treatment once a day, five days a week for approximately five and a half weeks.
- interventionNames
- Radiation: IMRT
Primary outcomes (1)
- measure
- Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification
- timeFrame
- Within 1 year of protocol registration
- description
- The study will be deemed infeasible if greater than 10% of enrolled patients have at least one of the following outcomes: 1. Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her. 2. Within 1 year of protocol registration, the patient develops radiation pneumonitis toxicity of greater than or equal to grade 3 by CTCAE scales. 3. Within 1 year of protocol registration, the patient develops any local or regional breast cancer recurrence. 4. Within 1 year of protocol registration, the patient dies from causes judged to be related to her treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female gender * Age ≥ 18 years * Invasive primary female breast cancer * Pathologically proven regional nodal metastasis * Status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection. * Signed study specific consent form Exclusion Criteria: * Distant metastasis * Currently Pregnant * Psychiatric or addictive disorders that preclude informed consent * Time from initial diagnosis to the start of radiation therapy \> one year * Estimated life expectancy judged to be \< one year * Prior radiation to the ipsilateral breast or chest wall * Primary breast cancer is lymphoma or sarcoma * Patients being treated with concurrent chemotherapy.
References
Publications (76)
- BACKGROUNDEl Moussaoui R, Opmeer BC, Bossuyt PM, Speelman P, de Borgie CA, Prins JM. Development and validation of a short questionnaire in community acquired pneumonia. Thorax. 2004 Jul;59(7):591-5. doi: 10.1136/thx.2003.015107. PMID 15223867
- BACKGROUNDRagaz J, Jackson SM, Le N, Plenderleith IH, Spinelli JJ, Basco VE, Wilson KS, Knowling MA, Coppin CM, Paradis M, Coldman AJ, Olivotto IA. Adjuvant radiotherapy and chemotherapy in node-positive premenopausal women with breast cancer. N Engl J Med. 1997 Oct 2;337(14):956-62. doi: 10.1056/NEJM199710023371402. PMID 9309100
- BACKGROUNDRagaz J, Olivotto IA, Spinelli JJ, Phillips N, Jackson SM, Wilson KS, Knowling MA, Coppin CM, Weir L, Gelmon K, Le N, Durand R, Coldman AJ, Manji M. Locoregional radiation therapy in patients with high-risk breast cancer receiving adjuvant chemotherapy: 20-year results of the British Columbia randomized trial. J Natl Cancer Inst. 2005 Jan 19;97(2):116-26. doi: 10.1093/jnci/djh297. PMID 15657341
- BACKGROUNDOvergaard M, Hansen PS, Overgaard J, Rose C, Andersson M, Bach F, Kjaer M, Gadeberg CC, Mouridsen HT, Jensen MB, Zedeler K. Postoperative radiotherapy in high-risk premenopausal women with breast cancer who receive adjuvant chemotherapy. Danish Breast Cancer Cooperative Group 82b Trial. N Engl J Med. 1997 Oct 2;337(14):949-55. doi: 10.1056/NEJM199710023371401. PMID 9395428
- BACKGROUNDOvergaard M, Jensen MB, Overgaard J, Hansen PS, Rose C, Andersson M, Kamby C, Kjaer M, Gadeberg CC, Rasmussen BB, Blichert-Toft M, Mouridsen HT. Postoperative radiotherapy in high-risk postmenopausal breast-cancer patients given adjuvant tamoxifen: Danish Breast Cancer Cooperative Group DBCG 82c randomised trial. Lancet. 1999 May 15;353(9165):1641-8. doi: 10.1016/S0140-6736(98)09201-0. PMID 10335782
- BACKGROUNDClarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.