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

NCT02610621 | Withdrawn Phase 2

• 1 other identifier: IIT2015-11-Giuliano-SNBO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Clinically node negative; T1 and T2 invasive breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Lumpectomy without sentinel node biopsy

EXPERIMENTAL

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

Interventions

Lumpectomy without sentinel node biopsy 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.

Lumpectomy without sentinel node biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Lymph Node Excision; Investigative Techniques

Study Officials

• Armando Giuliano, MD

  Cedars-Sinal Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: December 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2020
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

US (1)