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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Breast Cancer
Interventions Drug: systemic chemotherapy
Procedure: axillary lymph node dissection
Procedure: neoadjuvant therapy
Procedure: sentinel lymph node biopsy
Procedure: therapeutic conventional surgery
Procedure: ultrasound imaging
Enrollment 756
Recruitment Details  
Pre-assignment Details  
Arm/Group Title cN1 Cohort cN2 Cohort cN3 Patients (Ineligible)
Hide Arm/Group Description Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and 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. Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and 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. Patients who were staged according to the AJCC staging system as cN3.
Period Title: Overall Study
Started 707 47 2
Completed 663 38 0
Not Completed 44 9 2
Reason Not Completed
Terminated prior to surgery             27             7             0
Ineligible             17             2             2
Arm/Group Title cN1 Cohort cN2 Cohort Total
Hide Arm/Group Description Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and 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. Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and 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. Total of all reporting groups
Overall Number of Baseline Participants 663 38 701
Hide Baseline Analysis Population Description
Only cN1 and cN2 patients who completed the study were included.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 663 participants 38 participants 701 participants
18-39 years old 120 4 124
40-49 years old 213 15 228
50-59 years old 197 10 207
60-69 years old 112 5 117
greater than 70 years old 21 4 25
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 663 participants 38 participants 701 participants
Female
663
 100.0%
38
 100.0%
701
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 663 participants 38 participants 701 participants
663
 100.0%
38
 100.0%
701
 100.0%
1.Primary Outcome
Title 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]
Hide Description 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.
Time Frame At time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Of the cN1 Cohort patients who Started the study (see Participant Flow), only patients with residual nodal disease were included in this analysis.
Arm/Group Title cN1 Cohort
Hide Arm/Group Description:
Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and 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.
Overall Number of Participants Analyzed 525
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
12.6
(9.85 to 16.05)
2.Secondary Outcome
Title 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]
Hide Description 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.
Time Frame At time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Of the cN2 Cohort patients who Started the study (see Participant Flow), only patients with residual nodal disease were included in this analysis.
Arm/Group Title cN2 Cohort
Hide Arm/Group Description:
Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and 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.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of false-negative SLN finding
0
(0 to 23.2)
3.Secondary Outcome
Title False-negative Rate (FNR) Under the Selection Process by Axillary Ultrasound (AUS) Status After Completion of Neoadjuvant Chemotherapy (NAC)
Hide Description 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.
Time Frame At the time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Post-chemotherapy AUS Normal
Hide Arm/Group Description:
Patients with lymph nodes classified as normal if the radiologist was unable to visualize any lymph nodes on axillary ultrasound (AUS) or indicated that the lymph nodes were normal in morphologic appearance.
Overall Number of Participants Analyzed 470
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of false-negative SLN finding
12.6
(9.5 to 16.3)
4.Secondary Outcome
Title Node Status After Preoperative Chemotherapy, as Measured by the Total Number of Positive Nodes (SLN+ALND)
Hide Description 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.
Time Frame At time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with post-chemotherapy AUS results were included in this analysis.
Arm/Group Title Post-chemotherapy AUS Normal Post-chemotherapy AUS Suspicious
Hide Arm/Group Description:
Patients with lymph nodes classified as normal if the radiologist was unable to visualize any lymph nodes on axillary ultrasound (AUS) or indicated that the lymph nodes were normal in morphologic appearance.
Patients with lymph nodes with abnormal morphology on AUS were classified as suspicious.
Overall Number of Participants Analyzed 430 181
Measure Type: Count of Participants
Unit of Measure: Participants
0
171
  39.8%
47
  26.0%
1-3
173
  40.2%
89
  49.2%
4-10
42
   9.8%
28
  15.5%
>10
10
   2.3%
7
   3.9%
Missing/Unknown
34
   7.9%
10
   5.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Post-chemotherapy AUS Normal, Post-chemotherapy AUS Suspicious
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Pathologic Complete Nodal Response (pCR) Rate
Hide Description 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.
Time Frame At the time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in cN1 and cN2 Cohort who had at least two SLNs excised and went on to complete ALND were included in this analysis.
Arm/Group Title cN1 Cohort cN2 Cohort
Hide Arm/Group Description:
Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and 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.
Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and 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.
Overall Number of Participants Analyzed 525 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of SLN surgery/ALND
41.0
(36.7 to 45.3)
46.1
(26.6 to 66.6)
6.Secondary Outcome
Title Residual Cancer Burden Class
Hide Description 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.
Time Frame At time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title cN1 Cohort cN2 Cohort
Hide Arm/Group Description:
Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and 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.
Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and 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.
Overall Number of Participants Analyzed 663 38
Measure Type: Number
Unit of Measure: participants
missing data 162 6
0 182 13
I 33 0
II 136 10
III 150 9
7.Other Pre-specified Outcome
Title Disease-Free Survival
Hide Description [Not Specified]
Time Frame Up to 10 years
Outcome Measure Data Not Reported
Time Frame 1-2 weeks post surgery
Adverse Event Reporting Description Each CTCAE term is a unique representation of a specific event used for medical documentation & scientific analysis & is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who started treatment & were evaluated for AEs. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and are in the SAE table.
 
Arm/Group Title cN1 Cohort cN2 Cohort
Hide Arm/Group Description Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and 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. Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and 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.
All-Cause Mortality
cN1 Cohort cN2 Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   1/676 (0.15%)      0/39 (0.00%)    
Hide Serious Adverse Events
cN1 Cohort cN2 Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/676 (0.89%)      0/39 (0.00%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  1/676 (0.15%)  1 0/39 (0.00%)  0
General disorders     
Multi-organ failure  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Infections and infestations     
Infection  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Skin infection  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Wound infection  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Upper extremity dysfunction  1  1/676 (0.15%)  1 0/39 (0.00%)  0
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
cN1 Cohort cN2 Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   192/676 (28.40%)      9/39 (23.08%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  10/676 (1.48%)  10 1/39 (2.56%)  1
Lymphatic disorder  1  4/676 (0.59%)  4 2/39 (5.13%)  2
Ear and labyrinth disorders     
Ear disorder  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Eye disorders     
Eye disorder  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Eye pain  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  13/676 (1.92%)  13 0/39 (0.00%)  0
Diarrhea  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Ileus  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Nausea  1  15/676 (2.22%)  15 0/39 (0.00%)  0
Rectal pain  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Vomiting  1  3/676 (0.44%)  3 0/39 (0.00%)  0
General disorders     
Chest pain  1  3/676 (0.44%)  3 0/39 (0.00%)  0
Chills  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Edema limbs  1  15/676 (2.22%)  15 0/39 (0.00%)  0
Fatigue  1  41/676 (6.07%)  41 3/39 (7.69%)  3
Fever  1  5/676 (0.74%)  5 0/39 (0.00%)  0
Injection site reaction  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Localized edema  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Pain  1  54/676 (7.99%)  54 2/39 (5.13%)  2
Infections and infestations     
Catheter related infection  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Device related infection  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Infection  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Peripheral nerve infection  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Skin infection  1  3/676 (0.44%)  3 0/39 (0.00%)  0
Soft tissue infection  1  1/676 (0.15%)  1 1/39 (2.56%)  1
Upper respiratory infection  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Urinary tract infection  1  1/676 (0.15%)  1 1/39 (2.56%)  1
Wound infection  1  6/676 (0.89%)  6 0/39 (0.00%)  0
Injury, poisoning and procedural complications     
Bruising  1  5/676 (0.74%)  5 1/39 (2.56%)  1
Postoperative hemorrhage  1  1/676 (0.15%)  1 1/39 (2.56%)  1
Seroma  1  16/676 (2.37%)  16 2/39 (5.13%)  2
Small intestinal anastomotic leak  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Wound dehiscence  1  2/676 (0.30%)  2 0/39 (0.00%)  0
Investigations     
Gamma-glutamyltransferase increased  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Lymphocyte count decreased  1  2/676 (0.30%)  2 0/39 (0.00%)  0
Platelet count decreased  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Weight loss  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  3/676 (0.44%)  3 0/39 (0.00%)  0
Blood glucose increased  1  3/676 (0.44%)  3 0/39 (0.00%)  0
Dehydration  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Serum albumin decreased  1  2/676 (0.30%)  2 0/39 (0.00%)  0
Serum calcium decreased  1  2/676 (0.30%)  2 0/39 (0.00%)  0
Serum glucose decreased  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Serum magnesium decreased  1  2/676 (0.30%)  2 0/39 (0.00%)  0
Serum potassium decreased  1  2/676 (0.30%)  2 0/39 (0.00%)  0
Serum sodium decreased  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Back pain  1  2/676 (0.30%)  2 0/39 (0.00%)  0
Chest wall pain  1  15/676 (2.22%)  15 1/39 (2.56%)  1
Joint disorder  1  19/676 (2.81%)  19 1/39 (2.56%)  1
Joint pain  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Joint range of motion decreased cervical spine  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Muscle weakness upper limb  1  3/676 (0.44%)  3 0/39 (0.00%)  0
Musculoskeletal disorder  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Myalgia  1  6/676 (0.89%)  6 0/39 (0.00%)  0
Pain in extremity  1  22/676 (3.25%)  22 0/39 (0.00%)  0
Upper extremity dysfunction  1  11/676 (1.63%)  11 0/39 (0.00%)  0
Nervous system disorders     
Dizziness  1  4/676 (0.59%)  4 0/39 (0.00%)  0
Headache  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Neurological disorder NOS  1  2/676 (0.30%)  2 0/39 (0.00%)  0
Peripheral motor neuropathy  1  7/676 (1.04%)  7 0/39 (0.00%)  0
Peripheral sensory neuropathy  1  46/676 (6.80%)  46 1/39 (2.56%)  1
Seizure  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Syncope  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Taste alteration  1  2/676 (0.30%)  2 0/39 (0.00%)  0
Psychiatric disorders     
Anxiety  1  5/676 (0.74%)  5 0/39 (0.00%)  0
Confusion  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Depression  1  3/676 (0.44%)  3 0/39 (0.00%)  0
Insomnia  1  7/676 (1.04%)  7 0/39 (0.00%)  0
Renal and urinary disorders     
Cystitis  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Urinary frequency  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Urinary retention  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Urine discoloration  1  8/676 (1.18%)  8 0/39 (0.00%)  0
Reproductive system and breast disorders     
Breast pain  1  39/676 (5.77%)  39 2/39 (5.13%)  2
Ovulation pain  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Vaginal pain  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Cough  1  3/676 (0.44%)  3 0/39 (0.00%)  0
Dyspnea  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Pharyngolaryngeal pain  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  4/676 (0.59%)  4 0/39 (0.00%)  0
Chest wall necrosis  1  3/676 (0.44%)  3 0/39 (0.00%)  0
Decubitus ulcer  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Nail disorder  1  2/676 (0.30%)  2 2/39 (5.13%)  2
Pruritus  1  3/676 (0.44%)  3 0/39 (0.00%)  0
Rash desquamating  1  3/676 (0.44%)  3 0/39 (0.00%)  0
Skin disorder  1  9/676 (1.33%)  9 0/39 (0.00%)  0
Skin hyperpigmentation  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Sweating  1  2/676 (0.30%)  2 0/39 (0.00%)  0
Vascular disorders     
Hematoma  1  11/676 (1.63%)  11 0/39 (0.00%)  0
Hot flashes  1  4/676 (0.59%)  4 0/39 (0.00%)  0
Lymphedema  1  1/676 (0.15%)  1 0/39 (0.00%)  0
Thrombosis  1  3/676 (0.44%)  3 0/39 (0.00%)  0
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Judy C. Boughey, MD
Organization: Mayo Clinic
Phone: 507-284-3629
EMail: boughey.judy@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00881361    
Other Study ID Numbers: ACOSOG-Z1071
ACOSOG-Z1071
CDR0000640100 ( Registry Identifier: NCI Physician Data Query )
First Submitted: April 14, 2009
First Posted: April 15, 2009
Results First Submitted: September 19, 2018
Results First Posted: December 5, 2018
Last Update Posted: August 7, 2020