Clinical trial · Interventional
Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response
Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI voluntarily closed the study. Will be reopened as a national cooperative group trial.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with HER2+ breast cancer who achieve pathologic complete response.
Conditions
Conditions (2)
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 |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omit breast radiation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Omit breast radiation
- interventionNames
- Other: Omit breast radiation
Primary outcomes (1)
- measure
- Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial
- timeFrame
- At time of consent. Assessed up to 3 years
- description
- Measured by the number of recruited patients over the number of patients approached to participate to the trial. Feasibility will be defined as recruitment rate of greater or equal to 25% among patients who are eligible to participate in the trial.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age ≥ 40 years * Patients must have a tissue diagnosis of HER2+ breast cancer * Patients must have documented clinical T1-3, N0, M0 disease prior to receiving neo-adjuvant chemotherapy * Patients must have undergone neo-adjuvant chemotherapy and targeted HER2 therapy prior to surgery and plan for completion of adjuvant systemic therapy as directed by their medical oncologist * Patients must have completed partial mastectomy/lumpectomy and sentinel node biopsy or axillary node dissection. * Patient must have documented pathologic complete response (defined as no residual invasive or in situ disease in the breast or axilla, including free of isolated tumor cells or micrometastasis) Exclusion Criteria: * Breastfeeding * Prior history of breast cancer (invasive or ductal carcinoma in-situ) in either breast * Prior adjuvant radiation therapy * Patients with diagnosis of inflammatory breast cancer * Patients with known BRCA mutation or other known breast cancer related deleterious mutations
References
Publications (0)
Data not yet available