Status:
ACTIVE_NOT_RECRUITING
Omission of Radiation in Patients With Her-2 Positive Breast Cancer
Lead Sponsor:
University of Kansas Medical Center
Conditions:
HER2-positive Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03460067
Start Date
February 23 2018
End Date
July 16 2027
Last Update
March 27 2025
Active Locations (1)
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1
University of Kansas Medical Center/ Cancer Center
Kansas City, Kansas, United States, 66190