Breast Cancer, HER2-positive Breast Cancer
Conditions
Keywords
HER2, partial mastectomy, lumpectomy, sentinel node biopsy, axillary node dissection, pathologic complete response, breast cancer, HER2-positive
Brief summary
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.
Interventions
OTHEROmit breast radiation
Omit breast radiation for 3 years after surgery
Sponsors
Armando Giuliano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of enrolling patients measured by proportion of recruited patients to participate in the trial | At time of consent. Assessed up to 3 years | 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. |
Countries
United States
Outcome results
None listed