Phase 2
Completed N=25
Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery
Anatomic Stage I Breast Cancer AJCC v8 · Anatomic Stage IA Breast Cancer AJCC v8 · Anatomic Stage IB Breast Cancer AJCC v8 · Anatomic Stage IIA Breast Cancer AJCC v8
Source: ClinicalTrials.gov NCT03624478 ↗
Enrolled (actual)
25
Serious AEs
8.3%
Results posted
Dec 2022
Primary outcomePrimary: Pathologic Complete Response (pCR) Rate Defined as a Residual Tumor Burden of 0-1 in the Surgical Specimen — 0.64 proportion of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response (pCR) Rate Defined as a Residual Tumor Burden of 0-1 in the Surgical Specimen |
0.64 | — |
| SECONDARY Number of Participants With Acute Adverse Events (AE) |
16; 8; 19; 5 | — |
| SECONDARY Incidence of Late Adverse Events |
— | — |
| SECONDARY Locoregional Control |
— | — |
| SECONDARY Invasive Disease-free Survival |
— | — |
| SECONDARY Distant Recurrence |
— | — |
| SECONDARY Disease- Free Survival |
— | — |
| SECONDARY Cause-specific Survival |
— | — |
| SECONDARY Overall Survival |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03624478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.