Clinical trial · Interventional
Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery
A Pilot/Phase II Trial of Hypofractionated Radiotherapy to the Whole Breast Alone Before Breast Conserving Surgery
NCT03624478CI-TRIAL-00111725completedPhase 2Results postedClinicalTrials.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 phase II trial studies how well hypofractionated radiation therapy works in treating participants with breast cancer before surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Prognostic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Prognostic Stage IB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Prognostic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Prognostic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (hypofractionated radiation therapy)
- description
- Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy.
- interventionNames
- Radiation: Hypofractionated Radiation Therapy
Primary outcomes (1)
- measure
- Pathologic Complete Response (pCR) Rate Defined as a Residual Tumor Burden of 0-1 in the Surgical Specimen
- timeFrame
- up to 2 years
- description
- The proportion of successes (number of patients achieving pCR at time of definitive surgery) will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of breast cancer * Clinical stage T0-T2 N0 M0 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2 * Able to and provides Institutional Review Board (IRB) approved study specific written informed consent * Study entry must be within 120 days of last biopsy (breast) * Able to complete all mandatory tests * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Planned breast surgery and indications for whole breast radiotherapy Exclusion Criteria: * Medical contraindication to receipt of radiotherapy * Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent * Active systemic lupus or scleroderma * Pregnancy * Women of childbearing potential who are unwilling to employ adequate contraception * Prior receipt of ipsilateral breast or chest wall radiation * Recurrent breast cancer * Indications for comprehensive regional nodal irradiation * No neo-adjuvant therapy
References
Publications (0)
Data not yet available
No reference posted for this study.