Not provided
Not provided
Not provided
Not provided
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Stopped due to low percentage of patients with detectable CTCs at baseline.
Not provided
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| Name | Class |
|---|---|
| Barnes-Jewish Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.
Not provided
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plavix and Aspirin | Experimental | 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 only | No Intervention | Observation by treating physician |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plavix | Drug |
|
| |
| Aspirin |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs | Measured by number of patients who have detectable circulating tumor cells | Week 4 |
| Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug | Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type. | Maximum of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time | 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 | Baseline, 2 weeks and 1 month |
Not provided
Inclusion Criteria:
Women with metastatic breast cancer who are completing planned course of chemotherapy with planned treatment break
On stable hormone therapy for at least 2 months are also eligible for the study
Estimated survival of at least 3 months
No platelet inhibitor therapy within 1 month of study entry
Platelets ≥ 100,000
Coagulation screening tests within normal range (INR between 0.81 and 1.20)
Normal kidney and liver function as defined by:
Able to provide signed, informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Katherine N Weilbaecher, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Not provided
Not provided
This study opened for enrollment in January 6, 2006 and closed enrollment in May 25, 2010
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Plavix and Aspirin | 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. |
| FG001 | Observation Only | Observation by treating physician |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Plavix and Aspirin | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs | Measured by number of patients who have detectable circulating tumor cells | 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. | Posted | Number | participants | Week 4 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plavix and Aspirin | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT | Investigations | CTCAE (3.0) | Systematic Assessment |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Weilbacher, M.D, | Department of Medicine Div. of Oncology, Washington University School of Medicine St. Louis MO | Fax: 314-454-8973 | kweiblac@dom.wustl.edu |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups |
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). |
| Baseline, 2 weeks and 1 month |
| Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups | Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups | Baseline, 2 weeks and 1 month |
| Progression Free Survival | Maximum of 6 months |
| Protocol Violation |
|
| Disease Progression |
|
| BG001 | Observation Only | Observation by treating physician |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| The Number of Participants with Detectable Positive Circulating Tumor Cells (CTCs=>1) at Baseline | The number of participants with detectable CTCs (>= 1 CTC) was calculated at baseline. | Number | participants |
|
| Human Epidermal Growth Factor Receptor 2 Positivity (HER2+) | 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. | Number | participants |
|
| Estrogen Receptor Positivity (ER+) | Estrogen Receptor + means that the breast cancer is considered "hormone-receptor-positive." | Number | participants |
|
| Number of Metastatic Sites | Number | participants |
|
| Number of Previous Metastatic Chemotherapy Regimens | Number | participants |
|
| Number of Previous Metastatic Endocrine Therapies | Number | participants |
|
| Number of Participants Concurrently using Trastuzumab | Number | participants |
|
| Number of Participants Concurrently using Bisphosphonate | Number | participants |
|
| Number of Participants who Smoke | Number | participants |
|
| OG001 | Observation Only | Observation by treating physician |
|
|
| Primary | Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug | Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type. | Plavix and Aspirin: 1 patient withdrew consent prior to starting 1 patient died prior to starting | Posted | Number | participants | Maximum of 6 months |
|
|
|
| Secondary | Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time | 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 | 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 | Posted | Number | percentage of participants | Baseline, 2 weeks and 1 month |
|
|
|
| Secondary | Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups | 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). | 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 | Posted | Mean | Standard Deviation | Aspirin Reaction Units | Baseline, 2 weeks and 1 month |
|
|
|
| Secondary | Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups | Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups | 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 | Posted | Mean | Standard Deviation | percentage of platelet inhibition | Baseline, 2 weeks and 1 month |
|
|
|
| Secondary | Progression Free Survival | This trial was terminated early due to futility, subjects were not followed for progression free-survival. | Posted | Maximum of 6 months |
|
|
| 3 |
| 24 |
| 24 |
| 24 |
| EG001 | Observation Only | Observation by treating physician | 1 | 24 | 24 | 24 |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Calf Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| AST | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Albumin, serum low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline Phosphate | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphedema | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dermatology other-Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dermatology other-bilateral breast inflammation and discoloration and alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema: Limb | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema Head and Neck | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema Trunk/genital | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage Respiratory Nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, GU Vagina | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot Flashes | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection G 1/2 Normal ANC Pulmonary (Neck NOS) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection G 1/2 Normal Pulmonary (upper airway) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection Unknown ANC Auditory /ear (external) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection Unknown ANC Pulmonary (Pharynx) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection Unknown ANC Renal (Urinary tract) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint -function | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Lymphatic other swelling | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Metabolic Lab/ Other BUN high | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Plasma protein low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood Alteration-Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy -cranial motor face | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy -motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy Sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| PTT | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Pain Neuralgia/Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain GI (Abdomen NOS) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain GI (stomach) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hip and Jaw Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain Pulmonary (Chest Thorax NOS) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash acne/acneiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash dermatitis assoc. with reaction : chemo | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal (Slight blood in urine/hematuria) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Persistent vaginal herpes | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin Breakdown decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sweating | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urine color change | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Liver Pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| 1 month 0 CTCs |
|
| Baseline 1-5 CTCs |
|
| 2 weeks 1-5 CTCs |
|
| 1 month 1-5 CTCs |
|
| Baseline >=5 CTS |
|
| 2 weeks >=5 CTCs |
|
| 1 month >=5 CTCs |
|
| 1 month ARU |
|
| 1 month |
|