Omission of Radiation in Patients With Her-2 Positive Breast Cancer
HER2-positive Breast Cancer
About this trial
This is an interventional treatment trial for HER2-positive Breast Cancer focused on measuring omission of radiation, trastuzumab, pertuzumab, biospecimen collection, lumpectomy
Eligibility Criteria
Inclusion Criteria:
- Ability to understand and the willingness to sign a written informed consent.
- Karnofsky Performance Status 50% to 100% (Appendix A).
- Women 40 years of age or older with a diagnosis of invasive ductal carcinoma
- Her-2 3+ or FISH ratio of 2.2 or higher, background gene expression with normal copy number
Only postmenopausal women will be eligible. Subjects will be classified as being postmenopausal if they have had:
- No spontaneous menses > 1 year, or
- Bilateral surgical oophorectomy, or
- No menses for < 1 year with FSH and estradiol levels in according to institutional standards
- cT1-2N0 on clinical staging (verified to have no suspicious axillary or internal mammary nodes on MRI or ultrasound)
- Undergo neoadjuvant chemotherapy with a trastuzumab based regimen prior to surgery and plan for completion of one year of trastuzumab
- Patients are required to undergo lumpectomy with sentinel lymph node biopsy
- Pathologic review shows no evidence of residual disease in the tumor bed (to also include no evidence of residual DCIS)
- Tumor bed should be no larger than 5 cm in size on pathologic review
- Fibrotic area of prior tumor located at least 3 mm away from surgical margins
- No evidence of treatment related change in the lymph nodes on pathologic review
Exclusion Criteria
- Diagnosis of inflammatory breast cancer
- Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more)
- Diagnosis of metastatic disease
Sites / Locations
- University of Kansas Medical Center/ Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
No Intervention
No Intervention
Arm A
Arm B
Arm C
Patient is required to have lumpectomy with sentinel lymph node biopsy shows pCR and will complete 1 year of trastuzumab +/- pertuzumab treatment. No radiation, or an omission of radiation, will be given on this arm, including external beam, brachytherapy or intraoperative radiation. Patients will be required to follow up with a medical, surgical, or radiation oncologist every 3 months for 5 years. At these follow up visits, a physical exam will be performed to assess for any disease recurrence. Screening mammogram or MRI is recommended every 6 months for patients on this arm.
Patient is required to have her-2 positive breast cancer, clinically node negative from exam. Patient will complete neoadjuvant chemotherapy per Medical Oncologist. This arm will undergo lumpectomy with sentinel lymph node biopsy shows pCR. The patient will proceed with radiation as standard of care. This arm includes a review of outcomes in the patient's medical chart as well as a collection of biospecimens such as blood and urine, for correlative studies.
Patient is required to have her-2 positive breast cancer, clinically node negative from exam. patient will complete neoadjuvant chemotherapy per Medical Oncologist. This arm will not undergo lumpectomy with sentinel lymph node biopsy shows pCR. The patient will proceed with radiation as standard of care. This arm includes a review of outcomes in the patient's medical chart as well as a collection of biospecimens, such as blood and urine, for correlative studies.