Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Anti-Infective Agents

Clopidogrel

Aspirin

Trichostatin A

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Purinergic P2Y Receptor Antagonists

Neurotransmitter Agents

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

Katherine N Weilbaecher, M.D.

The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.

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

The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients

Measured by number of patients who have detectable circulating tumor cells

Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.

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

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).

Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups

Barnes-Jewish Hospital

Washington University School of Medicine

Plavix and Aspirin

Observation Only

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

The number of participants with detectable CTCs (\>= 1 CTC) was calculated at baseline.

The Number of Participants with Detectable Positive Circulating Tumor Cells (CTCs=>1) at Baseline

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.

Human Epidermal Growth Factor Receptor 2 Positivity (HER2+)

Estrogen Receptor + means that the breast cancer is considered "hormone-receptor-positive."

Estrogen Receptor Positivity (ER+)

≥3

Number of Metastatic Sites

Number of Previous Metastatic Chemotherapy Regimens

≥2

Number of Previous Metastatic Endocrine Therapies

Number of Participants Concurrently using Trastuzumab

Number of Participants Concurrently using Bisphosphonate

Number of Participants who Smoke

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

Katherine Weilbacher, M.D,

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.

Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs

Bleeding (possibly related)

Back pain (unlikely related)

Plavix and Aspirin: 1 patient withdrew consent prior to starting 1 patient died prior to starting

Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug

Baseline 0 CTCs

2 week 0 CTCs

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

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

Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time

Baseline Aspirin Reaction UnitsARU

2 weeks ARU

1 month 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

Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups

Baseline

2 weeks

1 month

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

Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups

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

This trial was terminated early due to futility, subjects were not followed for progression free-survival.

Progression Free Survival

Overall Study

Spots Global Cancer Trial Database for A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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