Safety and Efficacy of Sentinel Node Biopsy Omission for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy

Study Overview
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Brief Summary
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Eligible patients will be female, ages 18 and older and have a diagnosis of Clinical T1 or T2 invasive breast cancer with no suspicious palpable adenopathy. Patients will undergo standard of care lumpectomy without sentinel node biopsy and whole breast radiation, followed by chemotherapy. Sentinel node biopsy is also considered standard care when patients have localized breast cancer. Treatment can often be influenced by whether the results of the biopsy show cancer or not. However, the biologic factors of the primary tumor have become more important in determining treatment recommendations in women with clinically node negative breast cancer.

Detailed Description
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The primary objective of the study is to determine the locoregional recurrence rate in patients with clinically node negative T1 and T2 breast cancer treated with systemic chemotherapy and whole breast irradiation in whom biopsy of the sentinel node is not performed. A locoregional recurrence is defined as any recurrence in the ipsilateral axillary nodes or in the supraclavicular nodes. After surgery, a patient will receive standard of care radiation on her affected breast and chemotherapy. A physical examination of the affected breast and regional lymph nodes will be conducted every six months for the first two years of follow up and then yearly for the last 3 years of follow up. Imaging of the affected breast will occur every 12 months after surgery per standard of care.

Official Title
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IIT2015-11-Giuliano: Safety and Efficacy of Omission of Sentinel Node Biopsy for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Lumpectomy without sentinel node biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female age 18 and older, not pregnant or lactating Clinical T1 or T2 invasive cancer with no suspicious palpable adenopathy If abnormal axillary nodes are seen on preoperative imaging, a negative fine needle aspiration or core biopsy is required for study entry. Planned treatment with breast conserving surgery and whole breast irradiation Chemotherapy required postoperatively based on patient and tumor characteristics at diagnosis Exclusion Criteria: Patients with suspicious palpable axillary adenopathy Patients with biopsy demonstrating axillary nodal metastases Patients with treatment by mastectomy Patients who have undergone neoadjuvant chemotherapy Patients with co-morbidities rendering the patient not a candidate for chemotherapy, surgery, or irradiation Patients treated with accelerated partial breast irradiation (APBI) Patients with contraindication to radiation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumpectomy without sentinel node biopsy<br>Subjects will undergo standard of care lumpectomy. A biopsy of the sentinel node will not be performed. After surgery, subjects will receive standard of care radiation on the affected breast and chemotherapy. | Procedure: Lumpectomy without sentinel node biopsy<br>* Biopsy of the sentinel node is considered standard of care treatment for women with localized breast cancer. The procedure will be eliminated at time of lumpectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A determination of the locoregional recurrence rate in patients with clinically node negative T1 and T2 breast cancer treated with systematic chemotherapy and whole breast radiation in whom sentinel node biopsy is not performed |  | Assessed up to 5 years from date of lumpectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinically node negative, T1 and T2 invasive breast cancer