Clinical trial · Interventional
Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
Multi-institution Phase II Trial of Intraoperative Electron Beam Radiotherapy Boost at the Time of Breast Conserving Surgery With Oncoplastic Reconstruction in Women With Early-Stage Breast Cancer
NCT02927912CI-TRIAL-00113532active not recruitingPhase 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 the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electron Beam Therapy | Radiation | — | UNRESOLVED |
| Lumpectomy | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Reconstructive Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (IOERT boost)
- description
- Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
- interventionNames
- Radiation: Electron Beam Therapy
- Procedure: Lumpectomy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Radiation: Radiation Therapy
- Procedure: Reconstructive Surgery
Primary outcomes (2)
- measure
- Number of Dose-limiting Adverse Events in the First 30 Patients Enrolled as Graded by the National Cancer Institute Common Toxicity Criteria Version 4.0
- timeFrame
- Up to 30 days after surgery and IOERT boost
- description
- If 4 or more complications in the first 10 patients, 7 or more out of the first 20 patients or 9 or more out of 30 patients are observed, then the study will be deemed not safe to continue. Summary statistics will be used to report all complications.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven diagnosis of breast cancer * Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer * Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician * Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup * History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry * Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis * Absolute neutrophil count \> 1800 cells/cubic mm * Platelets \>= 75,000 cells/cubic mm * Hemoglobin \>= 8 g/dL * Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry * Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy * Patients must provide study specific informed consent prior to study entry Exclusion Criteria: * Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer * Prior invasive non-breast malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entry * Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ \[LCIS\] is eligible) * Two or more cancers not resectable through a single lumpectomy incision * Bilateral breast cancer * Ductal breast carcinoma in situ (DCIS) only * Non-epithelial breast malignancies such as sarcoma/lymphoma * Male breast cancer * Paget's disease of the nipple * Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields * Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception * Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash * Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.