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Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00881361
Recruitment Status : Active, not recruiting
First Posted : April 15, 2009
Results First Posted : December 5, 2018
Last Update Posted : August 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE April 14, 2009
First Posted Date  ICMJE April 15, 2009
Results First Submitted Date  ICMJE September 19, 2018
Results First Posted Date  ICMJE December 5, 2018
Last Update Posted Date August 7, 2020
Actual Study Start Date  ICMJE July 2009
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
False Negative Rate (FNR) for Sentinel Lymph Node (SLN) Surgery After Chemotherapy When at Least 2 SLNs Were Excised in Women Initially Presenting With Biopsy-proven cN1 Breast Cancer [cN1 Cohort] [ Time Frame: At time of surgery ]
False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy when at least 2 SLNs were excised in women initially presenting with biopsy-proven cN1 breast cancer, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients initially presenting with biopsy-proven cN1 breast cancer with at least one positive lymph node by SLN or ALND multiplied by 100. A 2-sided Bayesian credible interval (BCI) for the true FNR was constructed.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
False negative rate defined as number of patients with no positive lymph nodes after SLN surgery and ≥ 1 positive lymph node by axillary lymph node dissection (ALND) divided by number of patients with ≥ 1 positive lymph node by ALND
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • False Negative Rate (FNR) for Sentinel Lymph Node (SLN) Surgery After Chemotherapy When at Least 2 SLNs Were Excised in Women Initially Presenting With Biopsy-proven cN2 Breast Cancer [cN2 Cohort] [ Time Frame: At time of surgery ]
    False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy when at least 2 SLNs were excised in women initially presenting with biopsy-proven cN2 breast cancer, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients initially presenting with biopsy-proven cN1 breast cancer with at least one positive lymph node by SLN or ALND multiplied by 100. An interval estimate of the SLN false negative rate will be constructed using the Duffy-Santner approach.
  • False-negative Rate (FNR) Under the Selection Process by Axillary Ultrasound (AUS) Status After Completion of Neoadjuvant Chemotherapy (NAC) [ Time Frame: At the time of surgery ]
    False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy in women with normal AUS and at least 2 SLNs were excised, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients with at least one positive lymph node by SLN or ALND multiplied by 100.
  • Node Status After Preoperative Chemotherapy, as Measured by the Total Number of Positive Nodes (SLN+ALND) [ Time Frame: At time of surgery ]
    Node status of patients after preoperative chemotherapy, as measured by the total number of positive nodes (SLN+ALND). Patients will be classified as node positive if they were determined to have at least one positive lymph node by SLN or ALND.
  • Pathologic Complete Nodal Response (pCR) Rate [ Time Frame: At the time of surgery ]
    Pathologic complete nodal response (pCR) rate (percentage) wherein a nodal pCR is pathologically node-negative (pN0) on the basis of SLN surgery and ALND. A 95% binomial confidence interval was constructed for the pCR rate.
  • Residual Cancer Burden Class [ Time Frame: At time of surgery ]
    Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. The calculated RCB index value can also be categorized as one of four RCB classes. The number of patients classified in the four RCB classes along with the number of patients missing this data by cohort are reported below. RCB of 0 represents a path complete response while increasing levels (I, then II, then III) indicate an increase in the 'amount' of residual disease remaining.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
  • Axillary ultrasound status after completion of preoperative chemotherapy (i.e., ultrasound evidence of residual lymphadenopathy versus no evidence of lymphadenopathy)
  • Node status after preoperative chemotherapy (positive status defined as ≥ 1 positive lymph node by SLN or ALND)
  • Extent of residual cancer burden
Current Other Pre-specified Outcome Measures
 (submitted: November 9, 2018)
Disease-Free Survival [ Time Frame: Up to 10 years ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer
Official Title  ICMJE A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women With Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis
Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage IIIB breast cancer.

Detailed Description

This is a multicenter study. Patients who plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes prior to registration to confirm eligibility and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. The primary and secondary objectives of the study are described below.

Primary Objective:

1. To determine the false negative rate for sentinel lymph node (SLN) surgery. Among the patients who have at least one sentinel lymph node identified and removed, false negative rate is defined as the number of patients declared to have no evidence of cancer in the SLN and are found to have at least one positive lymph node in the ALND divided by the total number of patients with at least one positive axillary lymph node by ALND.

Secondary Objectives:

  1. To determine how the axillary ultrasound status of the patient upon completion of preoperative chemotherapy (evidence of residual lymphadenopathy on the ultrasound examination versus no evidence of lymphadenopathy in the ultrasound examination) affects the false negative rate of SLN and how sonographic findings correlate with residual disease on final pathology.
  2. To determine the node status of patients after preoperative chemotherapy. Patients will be classified as node positive if they were determined to have at least one positive lymph node by SLN or ALND. Patients will be classified as node negative if all nodes examined by SLN and ALND were negative.
  3. To determine whether the false-negative rate for SLN surgery after preoperative chemotherapy is related to the extent of residual cancer burden (RCB) overall, or separately in the breast or regional nodal basin.
  4. To evaluate pathological complete response (pCR) rates (defined as no invasive disease in breast or lymph nodes) and disease-free survival (DFS) rates in node-positive patients receiving preoperative chemotherapy.

After completion of surgery, patients will visit the office for follow-up exams at 1-2 weeks then patients are followed every 6 months for 2 years, yearly for 2 years, then every other year for 6 years. The study closed to accrual and treatment on 5/29/12.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: systemic chemotherapy
  • Procedure: axillary lymph node dissection
  • Procedure: neoadjuvant therapy
  • Procedure: sentinel lymph node biopsy
  • Procedure: therapeutic conventional surgery
  • Procedure: ultrasound imaging
Study Arms  ICMJE Study cohort
Patients who plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection.
Interventions:
  • Drug: systemic chemotherapy
  • Procedure: axillary lymph node dissection
  • Procedure: neoadjuvant therapy
  • Procedure: sentinel lymph node biopsy
  • Procedure: therapeutic conventional surgery
  • Procedure: ultrasound imaging
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 3, 2015)
756
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2009)
550
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Eligibility Criteria:

  1. ≥ 18 years old
  2. ECOG/Zubrod Performance Status 0-1
  3. Female. Note: Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.
  4. Histologic diagnosis of invasive breast cancer, clinical stage T0-4 N1-2 M0 (excluding inflammatory breast cancer).
  5. FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy.
  6. Preoperative chemotherapy must be completed or planned for patient. NOTE: Patients enrolling on studies involving preoperative chemotherapy (through cooperative groups or institutional studies) may be eligible for this study, provided sentinel node surgery prior to preoperative chemotherapy was not required in the other studies.
  7. No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.
  8. No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of axillary status.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00881361
Other Study ID Numbers  ICMJE ACOSOG-Z1071
ACOSOG-Z1071
CDR0000640100 ( Registry Identifier: NCI Physician Data Query )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Judy Boughey, MD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP