Breast NeoplasmsPhase 2NCT00263211

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

A Phase 2 study testing Plavix and Aspirin in people with Breast Neoplasms, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Neoplasms
What is being tested?: Plavix and Aspirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited States
Study dates: Jan 2006to Sep 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Show all 10Show fewer

Normal kidney and liver function as defined by:
Aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase (SGOT))/alanine aminotransferase(ALT) ≤ 2 x Institutional Normal
Creatinine ≤ 2 x Institutional Normal
Able to provide signed, informed consent.

Who cannot join

Patients going on to surgery
Patients with a serious bleeding disorder that make them inappropriate candidates for NSAID therapy
Patients with history of significant bleeding related to peptic ulcer disease
Patients on standing doses of NSAIDS or platelet function inhibitors
Patients on standing doses of anti-coagulants

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

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

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

Conditions: Breast Neoplasms
Being tested: Plavix, Aspirin
Keywords: Breast Cancer, Metastatic, Platelet
Medical subject headings: Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlavixDrug
Also called Clopidogrel Bisulfate
AspirinDrug
Also called acetylsalicylic acid

Study groups in NCT00263211
Study group	Role	What they receive
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. Receives: Drug: Plavix; Drug: Aspirin
Observation only	No intervention	Observation by treating physician

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: Maximum of 6 months

Secondary outcomes (4)

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
Measured: Baseline, 2 weeks and 1 month
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).
Measured: 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
Measured: Baseline, 2 weeks and 1 month
Progression Free Survival
Measured: Maximum of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Sep 2009

First posted7 Dec 2005 (estimated)
Study startJan 2006
Primary completionSep 2009
Study completionSep 2009

Why it stopped: Stopped due to low percentage of patients with detectable CTCs at baseline.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00263211
Sponsor's protocol ID: 05-0427 / 201107340
Status last verified: Jan 2017
First submitted: 6 Dec 2005
Last updated: 15 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients
ClinicalTrials.gov ID: NCT00263211
Acronym / sponsor ID: 05-0427 / 201107340
Conditions: Breast Neoplasms
Keywords: Breast Cancer, Metastatic, Platelet
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Stopped due to low percentage of patients with detectable CTCs at baseline.
Enrolment: 48 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Barnes-Jewish Hospital
Study start: Jan 2006
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 7 Dec 2005 (estimated)
Results: Posted 15 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Plavix and Aspirin	Experimental	Drug: Plavix, Drug: AspirinPatients 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

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (5 listed)

Patients going on to surgery
Patients with a serious bleeding disorder that make them inappropriate candidates for NSAID therapy
Patients with history of significant bleeding related to peptic ulcer disease
Patients on standing doses of NSAIDS or platelet function inhibitors
Patients on standing doses of anti-coagulants

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlavixAlso: Clopidogrel Bisulfate	Drug	Plavix and Aspirin
AspirinAlso: acetylsalicylic acid	Drug	Plavix and Aspirin

Primary outcome

Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs
Time frame: Week 4
Measured by number of patients who have detectable circulating tumor cells
Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug
Time frame: Maximum of 6 months
Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.

4 secondary outcomes

Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
Time frame: Baseline, 2 weeks and 1 month
Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups
Time frame: Baseline, 2 weeks and 1 month
Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups
Time frame: Baseline, 2 weeks and 1 month
Progression Free Survival
Time frame: Maximum of 6 months

Results and safety

Results posted to the registry on 15 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Plavix and Aspirin	24	19
Observation Only	24	23

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

Time frame: Week 4. Number. Unit: participants

Measure	Plavix and Aspirin n = 19	Observation Only n = 23
Value	11	15

Population analysed: 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.

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

Time frame: Maximum of 6 months. Number. Unit: participants

Measure	Plavix and Aspirin n = 22	Observation Only n = 24
Bleeding (possibly related)	1	0
Back pain (unlikely related)	1	0

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

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Plavix and Aspirin	3 of 24 (12.5%)	24 of 24 (100%)	Not reported
Observation Only	1 of 24 (4.2%)	24 of 24 (100%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.

Related trials for Breast Neoplasms

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Katherine N Weilbaecher, M.D. principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Plavix and Aspirin in people with Breast Neoplasms, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00263211.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.