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Trial record 7 of 15 for:    "Breast Ductal Carcinoma" | "Citrate"

Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy

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: NCT00053898
Recruitment Status : Completed
First Posted : February 6, 2003
Results First Posted : March 12, 2018
Last Update Posted : September 20, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Southwest Oncology Group
American College of Surgeons
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: anastrozole
Drug: tamoxifen citrate
Radiation: Radiation Therapy
Enrollment 3104
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrozole + Tamoxifen Placebo
Hide Arm/Group Description

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

tamoxifen citrate: 20 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

anastrozole: 1 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

Period Title: Overall Study
Started 1552 1552
Completed 1538 1539
Not Completed 14 13
Reason Not Completed
No follow-up data from any source             9             12
Follow-up from telephone contact only             5             1
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrozole + Tamoxifen Placebo Total
Hide Arm/Group Description

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

Drug: tamoxifen citrate

20 mg/day and placebo for 5 years

Radiation: Radiation Therapy

Adjuvant radiation therapy

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

Drug: anastrozole

1 mg/day and placebo for 5 years

Radiation: Radiation Therapy

Adjuvant radiation therapy

Total of all reporting groups
Overall Number of Baseline Participants 1552 1552 3104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1552 participants 1552 participants 3104 participants
60.9  (7.8) 61.1  (7.8) 61.0  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1552 participants 1552 participants 3104 participants
Female
1552
 100.0%
1552
 100.0%
3104
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Patients Free From Breast Cancer
Hide Description Percentage of patients free from breast cancer event at 10 years where events include local, regional, or distant recurrence or contralateral breast cancer, invasive or DCIS.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrozole + Tamoxifen Placebo
Hide Arm/Group Description:

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

tamoxifen citrate: 20 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

anastrozole: 1 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

Overall Number of Participants Analyzed 1538 1539
Measure Type: Number
Unit of Measure: percentage of participants event-free
89.1 93.1
2.Secondary Outcome
Title Percentage of Patients Free From Invasive Breast Cancer
Hide Description Percentage of patients free from an invasive breast cancer event where events include invasive local, regional, or distant recurrence, or contralateral breast cancer, occurring as a first cancer event. Note that this endpoint includes only invasive breast cancers and the primary endpoint includes both invasive and DCIS breast cancers.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrozole + Tamoxifen Placebo
Hide Arm/Group Description:

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

tamoxifen citrate: 20 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

anastrozole: 1 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

Overall Number of Participants Analyzed 1538 1539
Measure Type: Number
Unit of Measure: percentage of participants event-free
93.3 96.4
3.Secondary Outcome
Title Percentage of Patients Free From Ipsilateral Recurrence
Hide Description Percentage of patients free from a breast cancer recurrence in the ipsilateral breast (invasive and DCIS), occurring as a first cancer event.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrozole + Tamoxifen Placebo
Hide Arm/Group Description:

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

tamoxifen citrate: 20 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

anastrozole: 1 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

Overall Number of Participants Analyzed 1538 1539
Measure Type: Number
Unit of Measure: percentage of participants event-free
94.6 96.4
4.Secondary Outcome
Title Percentage of Patients Free From Contralateral Breast Cancer
Hide Description Percentage of patients free from a breast cancer recurrence in the contralateral breast (invasive and DCIS), occurring as a first cancer event.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrozole + Tamoxifen Placebo
Hide Arm/Group Description:

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

tamoxifen citrate: 20 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

anastrozole: 1 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

Overall Number of Participants Analyzed 1538 1539
Measure Type: Number
Unit of Measure: percentage of participants event-free
94.7 97.0
5.Secondary Outcome
Title Percentage of Patients Free From Non-breast Secondary Cancer
Hide Description Percentage of patients free from any non-breast second primary cancer other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, or carcinoma in situ of the cervix, occurring as a first cancer event.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrozole + Tamoxifen Placebo
Hide Arm/Group Description:

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

tamoxifen citrate: 20 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

anastrozole: 1 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

Overall Number of Participants Analyzed 1538 1539
Measure Type: Number
Unit of Measure: percentage of participants event-free
91.5 91.9
6.Secondary Outcome
Title Percentage of Patients Free From Osteoporotic Fractures
Hide Description Percentage of patients free from fractures of the hip, spine, and wrist.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis for osteoporotic fractures included those whose method of contact for follow-up was by telephone. Two participants were excluded from the analysis because their date of fracture was unknown.
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrozole + Tamoxifen Placebo
Hide Arm/Group Description:

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

tamoxifen citrate: 20 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

anastrozole: 1 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

Overall Number of Participants Analyzed 1542 1539
Measure Type: Number
Unit of Measure: percentage of participants event-free
96.0 95.3
7.Secondary Outcome
Title Percentage of Patients Alive and Disease-free
Hide Description Percentage of patients free from a disease-free survival event where events include any recurrence, second primary cancer, and death from any cause. Lobular carcinoma in situ (LCIS), basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, and cervical carcinoma in situ will not be included as recurrences or second primary cancer.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrozole + Tamoxifen Placebo
Hide Arm/Group Description:

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

tamoxifen citrate: 20 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

anastrozole: 1 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

Overall Number of Participants Analyzed 1538 1539
Measure Type: Number
Unit of Measure: percentage of participants event-free
77.9 82.7
8.Secondary Outcome
Title Percentage of Patients Alive (Overall Survival)
Hide Description Percentage of patients alive.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis for overall survival included those whose method of contact for follow-up was by telephone.
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrozole + Tamoxifen Placebo
Hide Arm/Group Description:

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

tamoxifen citrate: 20 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

anastrozole: 1 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

Overall Number of Participants Analyzed 1543 1540
Measure Type: Number
Unit of Measure: percentage of participants event-free
92.1 92.5
9.Secondary Outcome
Title Quality of Life-Short Form 12 (SF-12) Physical Health Component Score
Hide Description The primary outcome of the QOL substudy was the Medical Outcomes Study-Short Form 12 (SF-12) physical health component scale score. The SF-12 physical score was calculated to have a range of 0–100 and was normalized to have a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The Quality of Life study was performed in a subset of B-35 participants. Participants were required to have submitted a baseline and at least one follow-up QOL form to be included in the analysis.
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrozole + Tamoxifen Placebo
Hide Arm/Group Description:

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

tamoxifen citrate: 20 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

anastrozole: 1 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

Overall Number of Participants Analyzed 601 592
Mean (Standard Deviation)
Unit of Measure: units on a scale
46.20  (10.13) 45.38  (10.25)
10.Secondary Outcome
Title Quality-adjusted Survival Time
Hide Description The mean quality-adjusted survival time (in months) in each treatment group, estimated by the Quality-Adjusted Time without Symptoms and Toxicity (Q-TWIST) method.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrozole + Tamoxifen Placebo
Hide Arm/Group Description:

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

tamoxifen citrate: 20 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

anastrozole: 1 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

Overall Number of Participants Analyzed 1538 1539
Mean (95% Confidence Interval)
Unit of Measure: months
104.4
(101.8 to 106.9)
102.9
(100.9 to 104.9)
Time Frame [Not Specified]
Adverse Event Reporting Description Participants at Risk includes any patient who submitted an AE form.
 
Arm/Group Title Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrazole + Tamoxifen Placebo
Hide Arm/Group Description

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

Drug: tamoxifen citrate

20 mg/day and placebo for 5 years

Radiation: Radiation Therapy

Adjuvant radiation therapy

anastrozole, 1 mg/day and a tamoxifen look-alike placebo for 5 years

Drug: anastrozole

1 mg/day and placebo for 5 years

Radiation: Radiation Therapy

Adjuvant radiation therapy

All-Cause Mortality
Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrazole + Tamoxifen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrazole + Tamoxifen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   73/1535 (4.76%)   62/1535 (4.04%) 
Blood and lymphatic system disorders     
Anemia  1  0/1535 (0.00%)  2/1535 (0.13%) 
Cardiac disorders     
Cardiac arrest  1  0/1535 (0.00%)  1/1535 (0.07%) 
Cardiac disorders - Other, specify  1  3/1535 (0.20%)  3/1535 (0.20%) 
Heart failure  1  1/1535 (0.07%)  0/1535 (0.00%) 
Myocardial infarction  1  6/1535 (0.39%)  8/1535 (0.52%) 
Supraventricular tachycardia  1  5/1535 (0.33%)  1/1535 (0.07%) 
Ventricular arrhythmia  1  2/1535 (0.13%)  1/1535 (0.07%) 
Acute coronary syndrome  1  4/1535 (0.26%)  0/1535 (0.00%) 
Left ventricular systolic dysfunction  1  2/1535 (0.13%)  2/1535 (0.13%) 
Endocrine disorders     
Endocrine disorders - Other, specify  1  0/1535 (0.00%)  1/1535 (0.07%) 
Eye disorders     
Eye disorders - Other, specify  1  1/1535 (0.07%)  1/1535 (0.07%) 
Gastrointestinal disorders     
Abdominal pain  1  0/1535 (0.00%)  1/1535 (0.07%) 
Colitis  1  2/1535 (0.13%)  1/1535 (0.07%) 
Diarrhea  1  0/1535 (0.00%)  1/1535 (0.07%) 
Gastric ulcer  1  0/1535 (0.00%)  1/1535 (0.07%) 
Gastrointestinal disorders - Other, specify  1  1/1535 (0.07%)  4/1535 (0.26%) 
General disorders     
Death NOS  1  1/1535 (0.07%)  1/1535 (0.07%) 
Fatigue  1  0/1535 (0.00%)  1/1535 (0.07%) 
Pain  1  1/1535 (0.07%)  1/1535 (0.07%) 
Sudden death NOS  1  0/1535 (0.00%)  1/1535 (0.07%) 
Edema limbs  1  1/1535 (0.07%)  0/1535 (0.00%) 
Infections and infestations     
Infections and infestations - Other, specify  1  2/1535 (0.13%)  8/1535 (0.52%) 
Wound infection  1  0/1535 (0.00%)  1/1535 (0.07%) 
Lung infection  1  2/1535 (0.13%)  0/1535 (0.00%) 
Investigations     
Aspartate aminotransferase increased (AST/SGOT)  1  1/1535 (0.07%)  0/1535 (0.00%) 
Blood antidiuretic hormone abnormal  1  0/1535 (0.00%)  1/1535 (0.07%) 
Cardiac troponin I increased  1  4/1535 (0.26%)  5/1535 (0.33%) 
Cardiac troponin T increased  1  1/1535 (0.07%)  0/1535 (0.00%) 
Cholesterol high  1  2/1535 (0.13%)  0/1535 (0.00%) 
CPK increased  1  1/1535 (0.07%)  1/1535 (0.07%) 
Creatinine increased  1  2/1535 (0.13%)  7/1535 (0.46%) 
Investigations - Other, specify  1  1/1535 (0.07%)  3/1535 (0.20%) 
Platelet count decreased  1  3/1535 (0.20%)  0/1535 (0.00%) 
GGT increased  1  0/1535 (0.00%)  1/1535 (0.07%) 
Metabolism and nutrition disorders     
Dehydration  1  0/1535 (0.00%)  3/1535 (0.20%) 
Hyperglycemia  1  1/1535 (0.07%)  1/1535 (0.07%) 
Hyperkalemia  1  0/1535 (0.00%)  1/1535 (0.07%) 
Hypertriglyceridemia  1  2/1535 (0.13%)  0/1535 (0.00%) 
Hyperuricemia  1  0/1535 (0.00%)  1/1535 (0.07%) 
Hypocalcemia  1  1/1535 (0.07%)  0/1535 (0.00%) 
Hypoglycemia  1  0/1535 (0.00%)  1/1535 (0.07%) 
Hypokalemia  1  3/1535 (0.20%)  2/1535 (0.13%) 
Hyponatremia  1  1/1535 (0.07%)  3/1535 (0.20%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/1535 (0.07%)  1/1535 (0.07%) 
Arthritis  1  0/1535 (0.00%)  2/1535 (0.13%) 
Bone pain  1  0/1535 (0.00%)  1/1535 (0.07%) 
Musculoskeletal and connective tissue disorder - Other, specify  1  1/1535 (0.07%)  2/1535 (0.13%) 
Myalgia  1  0/1535 (0.00%)  1/1535 (0.07%) 
Avascular necrosis  1  0/1535 (0.00%)  1/1535 (0.07%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  1/1535 (0.07%)  0/1535 (0.00%) 
Nervous system disorders     
Headache  1  1/1535 (0.07%)  0/1535 (0.00%) 
Intracranial hemorrhage  1  3/1535 (0.20%)  2/1535 (0.13%) 
Nervous system disorders - Other, specify  1  7/1535 (0.46%)  7/1535 (0.46%) 
Neuralgia  1  0/1535 (0.00%)  1/1535 (0.07%) 
Peripheral motor neuropathy  1  0/1535 (0.00%)  1/1535 (0.07%) 
Peripheral sensory neuropathy  1  0/1535 (0.00%)  1/1535 (0.07%) 
Seizure  1  2/1535 (0.13%)  1/1535 (0.07%) 
Stroke  1  1/1535 (0.07%)  0/1535 (0.00%) 
Syncope  1  1/1535 (0.07%)  2/1535 (0.13%) 
Psychiatric disorders     
Anxiety  1  1/1535 (0.07%)  0/1535 (0.00%) 
Confusion  1  2/1535 (0.13%)  1/1535 (0.07%) 
Depression  1  5/1535 (0.33%)  5/1535 (0.33%) 
Personality change  1  1/1535 (0.07%)  0/1535 (0.00%) 
Renal and urinary disorders     
Urinary incontinence  1  1/1535 (0.07%)  0/1535 (0.00%) 
Urinary tract obstruction  1  3/1535 (0.20%)  2/1535 (0.13%) 
Acute kidney injury  1  1/1535 (0.07%)  2/1535 (0.13%) 
Reproductive system and breast disorders     
Reproductive system and breast disorders - Other, specify  1  1/1535 (0.07%)  0/1535 (0.00%) 
Vaginal dryness  1  0/1535 (0.00%)  1/1535 (0.07%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  0/1535 (0.00%)  1/1535 (0.07%) 
Cough  1  0/1535 (0.00%)  2/1535 (0.13%) 
Dyspnea  1  4/1535 (0.26%)  4/1535 (0.26%) 
Hypoxia  1  1/1535 (0.07%)  4/1535 (0.26%) 
Pleural effusion  1  0/1535 (0.00%)  1/1535 (0.07%) 
Pneumonitis  1  1/1535 (0.07%)  0/1535 (0.00%) 
Pneumothorax  1  0/1535 (0.00%)  1/1535 (0.07%) 
Pulmonary fibrosis  1  1/1535 (0.07%)  0/1535 (0.00%) 
Respiratory failure  1  1/1535 (0.07%)  0/1535 (0.00%) 
Vascular disorders     
Hypertension  1  0/1535 (0.00%)  1/1535 (0.07%) 
Thromboembolic event  1  20/1535 (1.30%)  4/1535 (0.26%) 
Vascular disorders - Other, specify  1  1/1535 (0.07%)  0/1535 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: Tamoxifen + Anastrozole Placebo Group 2: Anastrazole + Tamoxifen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1024/1535 (66.71%)   1064/1535 (69.32%) 
Eye disorders     
Cataract  1  77/1535 (5.02%)  43/1535 (2.80%) 
General disorders     
Fatigue  1  187/1535 (12.18%)  196/1535 (12.77%) 
Pain  1  78/1535 (5.08%)  88/1535 (5.73%) 
Infections and infestations     
Infections and infestations - Other, specify  1  216/1535 (14.07%)  207/1535 (13.49%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  358/1535 (23.32%)  504/1535 (32.83%) 
Bone pain  1  96/1535 (6.25%)  152/1535 (9.90%) 
Musculoskeletal and connective tissue disorder - Other, specify  1  55/1535 (3.58%)  91/1535 (5.93%) 
Myalgia  1  168/1535 (10.94%)  218/1535 (14.20%) 
Nervous system disorders     
Headache  1  73/1535 (4.76%)  86/1535 (5.60%) 
Psychiatric disorders     
Depression  1  112/1535 (7.30%)  126/1535 (8.21%) 
Reproductive system and breast disorders     
Vaginal dryness  1  137/1535 (8.93%)  197/1535 (12.83%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  101/1535 (6.58%)  95/1535 (6.19%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  124/1535 (8.08%)  99/1535 (6.45%) 
Vascular disorders     
Hot flashes  1  655/1535 (42.67%)  570/1535 (37.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Department of Regulatory Affairs
Organization: NSABP Foundation, Inc
Phone: 412-339-5300
EMail: regulatory@nsabp.org
Layout table for additonal information
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00053898     History of Changes
Other Study ID Numbers: NSABP B-35
NSABP-B-35
SWOG-NSABP-B-35
NCCTG-NSABP-B-35
ACOSOG-NSABP-B-35
First Submitted: February 5, 2003
First Posted: February 6, 2003
Results First Submitted: November 20, 2017
Results First Posted: March 12, 2018
Last Update Posted: September 20, 2018