Back to resultsSafety and Efficacy of Sentinel Node Biopsy Omission for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lumpectomy without sentinel node biopsy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Clinically node negative, T1 and T2 invasive breast cancer
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
Sites / Locations
- Cedars-Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lumpectomy without sentinel node biopsy
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02610621
First Posted
November 18, 2015
Last Updated
October 11, 2016
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02610621
Brief Title
Safety and Efficacy of Sentinel Node Biopsy Omission for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
Official Title
IIT2015-11-Giuliano: Safety and Efficacy of Omission of Sentinel Node Biopsy for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Study may not be clinically relevant at this time.
Study Start Date
December 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Clinically node negative, T1 and T2 invasive breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lumpectomy without sentinel node biopsy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lumpectomy without sentinel node biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Giuliano, MD
Organizational Affiliation
Cedars-Sinal Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Sentinel Node Biopsy Omission for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy
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