Clinical trial · Interventional
Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer
A Single Center Phase II Prospective Clinical Trial to Assess the Feasibility of Preoperative Radiation Boost in Breast Cancer Patients
- 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 investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and shrink tumors. Delivering a boost radiation treatment before surgery when doctors can still visualize the tumor on imaging may help to better target the tumor and decrease the volume of normal irradiated tissue. By so doing, doctors may achieve better cosmetic outcomes and possibly better tumor control.
Conditions
Conditions (20)
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 0 Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| 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 | — |
| Anatomic Stage IIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast MRI | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Radiation Boost | Radiation | — | UNRESOLVED |
| Therapeutic Surgical Procedure | Procedure | — | UNRESOLVED |
| Whole Breast Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (radiation therapy boost, WBI)
- description
- Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Radiation: Radiation Boost
- Procedure: Therapeutic Surgical Procedure
- Radiation: Whole Breast Irradiation
- Other: Breast MRI
Primary outcomes (1)
- measure
- Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery.
- timeFrame
- For at least 36 months after WBI
- description
- Wound complications will be assessed by the surgeon and radiation oncologist and graded using descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5 (CTCAE v 5.0). This will be calculated as a proportion based on the number of events in the study. Will report the proportion with a 95% confidence interval (CI) using the Clopper-Pearson method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer patients with biopsy proven invasive cancer * Clinically and radiographically node negative * No indication of metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Synchronous bilateral invasive cancer allowed * Negative serum pregnancy test within one month from the radiation therapy (RT) boost delivery * Willingness to participate in the clinical trial and adhere to the study protocol * Individuals of all races, genders and ethnic groups are eligible for this trial Exclusion Criteria: * Need for neoadjuvant chemotherapy * Inflammatory breast cancer (cT4) * Multicentric tumor * Prior ipsilateral breast or thoracic RT * Contraindication for baseline magnetic resonance imaging (MRI) * Contraindication for surgery * Distant metastatic disease * Other synchronous cancer (besides bilateral breast) * Contraindication to radiation therapy (presence of scleroderma or other collagen vascular disease) * Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
References
Publications (0)
Data not yet available