The primary objective of this study is to describe the rate of local control in patients with her-2 positive early stage breast cancer with a complete response to chemotherapy and lumpectomy alone.
Participants, ages 40 and older diagnosed with stage I or stage II her-2 positive, node negative breast cancer patients will be recommended to continue trastuzumab +/- pertuzumab therapy after surgery to complete a full year of therapy as standard of care under the clinical management of the patient's medical oncologist. Once neoadjuvant chemotherapy has been completed, the patient will be separated in to one of three arms based on a set of criteria for each. If the patient wishes to take part in the study, but does not have a lumpectomy with sentinel lymph node biopsy showing pCR, the patient will be placed in to Arm C and will proceed with radiation as standard of care. If the patient wishes to take part in the study, and has a lumpectomy with sentinel lymph node biopsy showing pCR, but does not agree to omission of radiation, the patient will be placed in to Arm B and will proceed with radiation as standard of care. If the patient wishes to take part in the study, and has a lumpectomy with sentinel lymph node biopsy showing pCR and agrees to omission of radiation, the patient will be placed in to Arm A with follow up assessments occuring at 1 month post-op, and every 3 months up to 5 years post-op. Data will be collected on local, regional and distant recurrence at each follow-up.The self-administered FACT-B+4 quality of life questionnaire will be given to patients at baseline, at first postoperative visit, and at the one year post-operative visit. Patients enrolling prior to chemotherapy will be asked to fill out the Breast-Q™ at the time of their first surgical consultation. Patients enrolled post-surgery will be asked to fill out the Breast-Q™ at their first post-operative visit. All patients will be asked to fill out the Breast-Q™ at their yearly postoperative visits. The Breast-Q™ is a validated patient assessment of breast cosmesis. This tool has both pre operative and post-operative components. Pre-operative Breast-Q™ questionnaire data is not required of participants in this study who enroll postoperatively.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
No Radiation will be given. 1 year of trastuzumab +/- pertuzumab treatment will be given with 5 years of follow up occurring every 3 months to check for recurrence
University of Kansas Medical Center/ Cancer Center
Kansas City, Kansas, United States
Ipsilateral Breast Cancer Recurrence
Defined as biopsy positive her-2 positive tumor in the same breast
Time frame: up to 5 year post-op
Regional Nodal Recurrence
Will include recurrence in the ipsilateral draining axilla, supraclavicular fossa, or internal mammary nodes.
Time frame: 1 month post-op, every three months post-op for 5 years
Distance Metastasis
Defined as biopsy proven disease outside of the affected breast and draining lymphatics, or definitive radiographical evidence of distant disease, to include a positive bone scan or enhancing lesions on MRI brain.
Time frame: 1 month post-op, every three months post-op for 5 years
Overall Survival
Defined as death from any cause
Time frame: 1 month post-op, every three months post-op for 5 years
Quality of Life using FACT-B+4
Measured using scores from patient reported outcomes from FACT-B+4 questionnaire
Time frame: 1 month post-op, every three months post-op for 5 years
Cosmetic (Breast) Outcomes
Measured using scores from patient reported outcomes using the Breast Q questionnaire
Time frame: 1 month post-op, every three months post-op for 5 years
Lymphedema Rate
Assessed by a diagnosis of Lymphedema in the medical record by trained lymphedema nurse.
Time frame: 1 month post-op, every three months post-op for 5 years
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