Safety and Efficacy of Sentinel Node Biopsy Omission for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
IIT2015-11-Giuliano: Safety and Efficacy of Omission of Sentinel Node Biopsy for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: Assessed up to 5 years from date of lumpectomy
|
Assessed up to 5 years from date of lumpectomy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Armando Giuliano, MD, Cedars-Sinal Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT2015-11-Giuliano-SNBO
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