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A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT00263211
Recruitment Status : Terminated (Stopped due to low percentage of patients with detectable CTCs at baseline.)
First Posted : December 7, 2005
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Breast Neoplasms
Interventions Drug: Plavix
Drug: Aspirin
Enrollment 48
Recruitment Details This study opened for enrollment in January 6, 2006 and closed enrollment in May 25, 2010
Pre-assignment Details  
Arm/Group Title Plavix and Aspirin Observation Only
Hide Arm/Group Description Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen. Observation by treating physician
Period Title: Overall Study
Started 24 24
Completed 19 23
Not Completed 5 1
Reason Not Completed
Death             1             0
Withdrawal by Subject             3             0
Protocol Violation             1             0
Disease Progression             0             1
Arm/Group Title Plavix and Aspirin Observation Only Total
Hide Arm/Group Description Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen. Observation by treating physician Total of all reporting groups
Overall Number of Baseline Participants 24 24 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 48 participants
50.7  (12.01) 58.4  (12.06) 55.79  (12.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Female
24
 100.0%
24
 100.0%
48
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 24 participants 48 participants
24 24 48
The Number of Participants with Detectable Positive Circulating Tumor Cells (CTCs=>1) at Baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
12 18 30
[1]
Measure Description: The number of participants with detectable CTCs (>= 1 CTC) was calculated at baseline.
Human Epidermal Growth Factor Receptor 2 Positivity (HER2+)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
8 10 18
[1]
Measure Description: Some breast cancers have high amounts of a protein called HER2/neu on the surface of the cancer cells (called HER2/neu-positive (HER2-positive) breast cancer). The HER2/neu protein is important for cancer cell growth.
Estrogen Receptor Positivity (ER+)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
15 13 28
[1]
Measure Description: Estrogen Receptor + means that the breast cancer is considered “hormone-receptor-positive.”
Number of Metastatic Sites  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
1 8 9 17
2 7 7 14
≥3 9 8 17
Number of Previous Metastatic Chemotherapy Regimens  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
0 6 4 10
1 5 8 13
2 4 6 10
≥3 9 6 15
Number of Previous Metastatic Endocrine Therapies  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
0 8 11 19
1 7 3 10
≥2 9 10 19
Number of Participants Concurrently using Trastuzumab  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
5 9 14
Number of Participants Concurrently using Bisphosphonate  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
12 9 21
Number of Participants who Smoke  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
4 5 9
1.Primary Outcome
Title Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs
Hide Description Measured by number of patients who have detectable circulating tumor cells
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Plavix & Aspirin arm has 19 evaluable patients. 5 withdrew before 1-month data collection: death n=1 and withdrawal of consent n=1 prior to starting; surgery plans n=1; patient preference n=1; platelet inhibition use n=1; Observation only arm had 23 evaluable patients ; 1 patient withdrew during the first month due to disease progression.
Arm/Group Title Plavix and Aspirin Observation Only
Hide Arm/Group Description:
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
Observation by treating physician
Overall Number of Participants Analyzed 19 23
Measure Type: Number
Unit of Measure: participants
11 15
2.Primary Outcome
Title Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug
Hide Description Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.
Time Frame Maximum of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Plavix and Aspirin: 1 patient withdrew consent prior to starting 1 patient died prior to starting
Arm/Group Title Plavix and Aspirin Observation Only
Hide Arm/Group Description:
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
Observation by treating physician
Overall Number of Participants Analyzed 22 24
Measure Type: Number
Unit of Measure: participants
Bleeding (possibly related) 1 0
Back pain (unlikely related) 1 0
3.Secondary Outcome
Title Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
Hide Description Percent of patients with a given number/range of CTCs ( 0, 1-5 >+ 5) vs. time baseline 2-weeks and 1 month for plavix & Aspirin arm and observation only
Time Frame Baseline, 2 weeks and 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Denominator for Plavix & Aspirin arm at Baseline=22, at 2 weeks =20, at 4 weeks =19 Denominator for Observation only at Baseline=24, at 2 weeks=19, at 4 weeks =23
Arm/Group Title Plavix and Aspirin Observation Only
Hide Arm/Group Description:
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
Observation by treating physician
Overall Number of Participants Analyzed 22 24
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 0 CTCs 40.00 22.73
2 week 0 CTCs 45.00 40.00
1 month 0 CTCs 41.18 35.00
Baseline 1-5 CTCs 45.00 63.64
2 weeks 1-5 CTCs 31.58 45.00
1 month 1-5 CTCs 52.94 55.00
Baseline >=5 CTS 15.00 13.64
2 weeks >=5 CTCs 21.05 15.00
1 month >=5 CTCs 5.88 10.00
4.Secondary Outcome
Title Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups
Hide Description Mean platelet inhibition vs. time plotted for Plavix & Aspirin Arm and Observation group. Citrated whole blood is added to a test carriage containing fibrinogen-coated beads and a platelet activator (arachidonic acid to synthesize thromboxane A2). Using a turbidimetric-based optical detection system, aggregation of activated platelets to fibrinogen-coated beads increase light transmittance which is reported in Aspirin Reaction Units (ARU).
Time Frame Baseline, 2 weeks and 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Denominator for Plavix & Aspirin arm baseline n=22, 2 weeks n=20, 1 month n=19 Denominator for Observation only arm baseline n=24 , 2-weeks n=19, 1 month n=23
Arm/Group Title Plavix and Aspirin Observation Only
Hide Arm/Group Description:
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
Observation by treating physician
Overall Number of Participants Analyzed 22 24
Mean (Standard Deviation)
Unit of Measure: Aspirin Reaction Units
Baseline Aspirin Reaction UnitsARU 610.39  (57.64) 579.81  (92.10)
2 weeks ARU 435.33  (56.50) 578.35  (151.10)
1 month ARU 455.44  (94.70) 593.58  (88.81)
5.Secondary Outcome
Title Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups
Hide Description Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups
Time Frame Baseline, 2 weeks and 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Mean Platelet inhibition Denominator for Plavix & Aspirin arm baseline n=22, 2 weeks n=20, 1 month n=19 Denominator for control group baseline n=24 , 2-weeks n=19, 1 month n=23
Arm/Group Title Plavix and Aspirin Observation Only
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 22 24
Mean (Standard Deviation)
Unit of Measure: percentage of platelet inhibition
Baseline 9.85  (16.13) 13.00  (21.93)
2 weeks 37.35  (30.38) 9.05  (7.96)
1 month 35.56  (30.90) 7.05  (7.07)
6.Secondary Outcome
Title Progression Free Survival
Hide Description [Not Specified]
Time Frame Maximum of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This trial was terminated early due to futility, subjects were not followed for progression free-survival.
Arm/Group Title Plavix and Aspirin Observation Only
Hide Arm/Group Description:

Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.

Plavix

Observation by treating physician
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Plavix and Aspirin Observation Only
Hide Arm/Group Description Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen. Observation by treating physician
All-Cause Mortality
Plavix and Aspirin Observation Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Plavix and Aspirin Observation Only
Affected / at Risk (%) Affected / at Risk (%)
Total   3/24 (12.50%)   1/24 (4.17%) 
Blood and lymphatic system disorders     
Edema  1  1/24 (4.17%)  0/24 (0.00%) 
Gastrointestinal disorders     
Diarrhea  1  1/24 (4.17%)  1/24 (4.17%) 
Dysphagia  1  0/24 (0.00%)  1/24 (4.17%) 
Nausea  1  1/24 (4.17%)  0/24 (0.00%) 
Vomiting  1  1/24 (4.17%)  0/24 (0.00%) 
Mucositis  1  1/24 (4.17%)  0/24 (0.00%) 
Esophagitis  1  1/24 (4.17%)  0/24 (0.00%) 
Infections and infestations     
Pneumonia  1  0/24 (0.00%)  1/24 (4.17%) 
Metabolism and nutrition disorders     
Dehydration  1  1/24 (4.17%)  1/24 (4.17%) 
Musculoskeletal and connective tissue disorders     
Calf Pain  1  1/24 (4.17%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/24 (4.17%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Plavix and Aspirin Observation Only
Affected / at Risk (%) Affected / at Risk (%)
Total   24/24 (100.00%)   24/24 (100.00%) 
Blood and lymphatic system disorders     
Hemoglobin  1  7/24 (29.17%)  7/24 (29.17%) 
Ear and labyrinth disorders     
Tinnitus  1  1/24 (4.17%)  0/24 (0.00%) 
Gastrointestinal disorders     
Colitis  1  1/24 (4.17%)  0/24 (0.00%) 
Constipation  1  4/24 (16.67%)  4/24 (16.67%) 
Diarrhea  1  2/24 (8.33%)  2/24 (8.33%) 
Esophagitis  1  0/24 (0.00%)  1/24 (4.17%) 
Gastritis  1  3/24 (12.50%)  3/24 (12.50%) 
Nausea  1  8/24 (33.33%)  9/24 (37.50%) 
Pain GI (Abdomen NOS)  1  2/24 (8.33%)  2/24 (8.33%) 
Pain GI (stomach)  1  0/24 (0.00%)  1/24 (4.17%) 
Vomiting  1  0/24 (0.00%)  4/24 (16.67%) 
Heartburn  1  0/24 (0.00%)  3/24 (12.50%) 
Liver Pain  1  0/24 (0.00%)  1/24 (4.17%) 
General disorders     
Edema: Limb  1  5/24 (20.83%)  5/24 (20.83%) 
Edema Head and Neck  1  0/24 (0.00%)  1/24 (4.17%) 
Edema Trunk/genital  1  0/24 (0.00%)  1/24 (4.17%) 
Fatigue  1  8/24 (33.33%)  8/24 (33.33%) 
Fever  1  1/24 (4.17%)  0/24 (0.00%) 
Lymphatic other swelling  1  0/24 (0.00%)  1/24 (4.17%) 
Rigors/chills  1  0/24 (0.00%)  1/24 (4.17%) 
Sweating  1  0/24 (0.00%)  3/24 (12.50%) 
Infections and infestations     
Infection G 1/2 Normal ANC Pulmonary (Neck NOS)  1  1/24 (4.17%)  0/24 (0.00%) 
Infection G 1/2 Normal Pulmonary (upper airway)  1  0/24 (0.00%)  1/24 (4.17%) 
Infection Unknown ANC Auditory /ear (external)  1  1/24 (4.17%)  0/24 (0.00%) 
Infection Unknown ANC Pulmonary (Pharynx)  1  0/24 (0.00%)  1/24 (4.17%) 
Infection Unknown ANC Renal (Urinary tract)  1  1/24 (4.17%)  0/24 (0.00%) 
Injury, poisoning and procedural complications     
Bruising  1  9/24 (37.50%)  0/24 (0.00%) 
Fracture  1  0/24 (0.00%)  1/24 (4.17%) 
Investigations     
ALT  1  4/24 (16.67%)  0/24 (0.00%) 
AST  1  1/24 (4.17%)  0/24 (0.00%) 
Alkaline Phosphate  1  2/24 (8.33%)  2/24 (8.33%) 
Leukocytes  1  6/24 (25.00%)  6/24 (25.00%) 
Lymphopenia  1  5/24 (20.83%)  5/24 (20.83%) 
Neutrophils  1  3/24 (12.50%)  3/24 (12.50%) 
PTT  1  0/24 (0.00%)  2/24 (8.33%) 
Platelets  1  1/24 (4.17%)  0/24 (0.00%) 
Metabolism and nutrition disorders     
Albumin, serum low  1  0/24 (0.00%)  1/24 (4.17%) 
Anorexia  1  2/24 (8.33%)  2/24 (8.33%) 
Hypercalcemia  1  0/24 (0.00%)  1/24 (4.17%) 
Hyperglycemia  1  6/24 (25.00%)  6/24 (25.00%) 
Hyperkalemia  1  0/24 (0.00%)  1/24 (4.17%) 
Hypernatremia  1  0/24 (0.00%)  2/24 (8.33%) 
Hypertriglyceridemia  1  0/24 (0.00%)  1/24 (4.17%) 
Hyperuricemia  1  3/24 (12.50%)  0/24 (0.00%) 
Hypocalcemia  1  1/24 (4.17%)  0/24 (0.00%) 
Hypokalemia  1  0/24 (0.00%)  1/24 (4.17%) 
Hyponatremia  1  0/24 (0.00%)  1/24 (4.17%) 
Metabolic Lab/ Other BUN high  1  0/24 (0.00%)  3/24 (12.50%) 
Plasma protein low  1  3/24 (12.50%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders     
Joint -function  1  1/24 (4.17%)  0/24 (0.00%) 
Back Pain  1  4/24 (16.67%)  4/24 (16.67%) 
Bone Pain  1  0/24 (0.00%)  2/24 (8.33%) 
Joint Pain  1  5/24 (20.83%)  5/24 (20.83%) 
Muscle Pain  1  2/24 (8.33%)  2/24 (8.33%) 
Neck Pain  1  0/24 (0.00%)  1/24 (4.17%) 
Hip and Jaw Pain  1  2/24 (8.33%)  0/24 (0.00%) 
Nervous system disorders     
Dizziness  1  6/24 (25.00%)  6/24 (25.00%) 
Neuropathy -cranial motor face  1  0/24 (0.00%)  1/24 (4.17%) 
Neuropathy -motor  1  1/24 (4.17%)  0/24 (0.00%) 
Neuropathy Sensory  1  6/24 (25.00%)  6/24 (25.00%) 
Pain Neuralgia/Neuropathy  1  0/24 (0.00%)  2/24 (8.33%) 
Headache  1  8/24 (33.33%)  8/24 (33.33%) 
Psychiatric disorders     
Insomnia  1  0/24 (0.00%)  3/24 (12.50%) 
Mood Alteration-Anxiety  1  0/24 (0.00%)  1/24 (4.17%) 
Renal and urinary disorders     
Renal (Slight blood in urine/hematuria)  1  2/24 (8.33%)  0/24 (0.00%) 
Urine color change  1  2/24 (8.33%)  2/24 (8.33%) 
Reproductive system and breast disorders     
Hemorrhage, GU Vagina  1  1/24 (4.17%)  0/24 (0.00%) 
Persistent vaginal herpes  1  1/24 (4.17%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  6/24 (25.00%)  6/24 (25.00%) 
Dyspnea  1  1/24 (4.17%)  2/24 (8.33%) 
Hemorrhage Respiratory Nose  1  2/24 (8.33%)  0/24 (0.00%) 
Pain Pulmonary (Chest Thorax NOS)  1  0/24 (0.00%)  1/24 (4.17%) 
Pneumonitis  1  1/24 (4.17%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatology other-Pruritus  1  2/24 (8.33%)  1/24 (4.17%) 
Dermatology other-bilateral breast inflammation and discoloration and alopecia  1  0/24 (0.00%)  2/24 (8.33%) 
Rash acne/acneiforme  1  1/24 (4.17%)  0/24 (0.00%) 
Rash dermatitis assoc. with reaction : chemo  1  1/24 (4.17%)  0/24 (0.00%) 
Rash desquamation  1  0/24 (0.00%)  1/24 (4.17%) 
Rash erythema multiforme  1  0/24 (0.00%)  1/24 (4.17%) 
Skin Breakdown decubitus ulcer  1  1/24 (4.17%)  0/24 (0.00%) 
Vascular disorders     
Lymphedema  1  0/24 (0.00%)  2/24 (8.33%) 
Hematoma  1  1/24 (4.17%)  0/24 (0.00%) 
Hot Flashes  1  4/24 (16.67%)  4/24 (16.67%) 
Hypertension  1  1/24 (4.17%)  0/24 (0.00%) 
Hypotension  1  1/24 (4.17%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)

Inclusion of patients with no or few CTC's limited ability to distinguish anti-platelet therapeutic effect.

Early termination because of low probability of reaching statistical significance for primary outcome

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: Katherine Weilbacher, M.D,
Organization: Department of Medicine Div. of Oncology, Washington University School of Medicine St. Louis MO
Phone: Fax: 314-454-8973
EMail: kweiblac@dom.wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00263211     History of Changes
Other Study ID Numbers: 05-0427 / 201107340
First Submitted: December 6, 2005
First Posted: December 7, 2005
Results First Submitted: July 21, 2016
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017