Omission of Radiation in Patients With Her-2 Positive Breast Cancer

  • STATUS
    Recruiting
  • End date
    Jul 25, 2025
  • participants needed
    78
  • sponsor
    University of Kansas Medical Center
Updated on 25 January 2021
cancer
breast cancer
trastuzumab
her-2
breast cancer staging
ductal carcinoma
her-2 positive breast cancer

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.

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 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.

Details
Condition HER2 Positive Breast Cancer, her2/neu-positive breast cancer, her2-positive breast cancer
Treatment Omission of Radiation
Clinical Study IdentifierNCT03460067
SponsorUniversity of Kansas Medical Center
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 40 yrs?
Are you female?
Do you have HER2 Positive Breast Cancer?
Do you have any of these conditions: her2/neu-positive breast cancer or HER2 Positive Breast Cancer or her2-positive breast cancer?
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
Clear my responses

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