Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Pathologic Complete Response

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Pertuzumab

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.

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

Omission of Radiation

Shane Stecklein, MD, PhD

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.

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

Selective Use of Observation After Lumpectomy and Sentinel Lymph Node Biopsy in Her-2 Positive Patients With Pathologic Complete Response to Neoadjuvant Chemotherapy

Defined as biopsy positive her-2 positive tumor in the same breast

Will include recurrence in the ipsilateral draining axilla, supraclavicular fossa, or internal mammary nodes.

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.

Measured using scores from patient reported outcomes from FACT-B+4 questionnaire

Measured using scores from patient reported outcomes using the Breast Q questionnaire

Assessed by a diagnosis of Lymphedema in the medical record by trained lymphedema nurse.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Omission of Radiation in Patients With Her-2 Positive Breast Cancer	NCT03460067	HER2-positive B...	Omission of Rad...	40 Years -	University of Kansas Medical Center
Omission of Radiation in Patients With Her-2 Positive Breast Cancer	NCT03460067	HER2-positive B...	Omission of Rad...	40 Years -	University of Kansas Medical Center
Omission of Radiation in Patients With Her-2 Positive Breast Cancer	NCT03460067	HER2-positive B...	Omission of Rad...	40 Years -	University of Kansas Medical Center

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