Determine Feasibility of Quantifying Apoptosis and Bcl-2 Expression in CTCs in Women With Metastatic Breast Cancer

NCT ID: NCT00156273

Last Updated: 2017-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-10-31

Brief Summary

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We are trying to develop better ways to detect when cancer therapies are working.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1.Females at least 18 years of age 2 Diagnosis of metastatic breast cancer 3.ECOG Score of 0-2 4.Treating oncologist has decided to initiate any new systemic therapy with emphasis on recruiting patients commencing a taxane-based regimen. Taxine-based therapy may be docetaxel or paclitaxel, and it can be given on any schedule,including weekly or every 3 weeks. Other treatment can include non-taxane chemotherapy or trastuzumab-with or without other therapy.

5.Patient is willing to return for one or more additional \~18 mL blood draw (s) at 24-48-, and /or 72 hours and \~3-4 weeks after the initiation of therapy.At a minimum, patients must donate blood at baseline, one intermediate interval (24, 48, 72 hr) and at \~3-4 weeks 6.Signed Informed Consent Form

\-

Exclusion Criteria

Patient is unable and unwilling to provide a blood specimen at a minimum of one of the intermediate blood draw time points at 24, 48, or 72 hours -
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Smerage, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM 45808 Legacy 2004-0703

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2003.075

Identifier Type: -

Identifier Source: org_study_id

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