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

NCT ID: NCT02610621

Last Updated: 2016-10-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2020-04-30

Brief Summary

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

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lumpectomy without sentinel node biopsy

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.

Group Type: EXPERIMENTAL

Lumpectomy without sentinel node biopsy

Intervention Type: PROCEDURE

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.

Interventions

Lumpectomy without sentinel node biopsy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Armando Giuliano

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Armando Giuliano, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinal Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

IIT2015-11-Giuliano-SNBO

Identifier Type: -

Identifier Source: org_study_id