A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-12-31

Brief Summary

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This is a pilot study evaluating the use of tumor derived exosomes as a marker for response to therapy in women receiving neoadjuvant chemotherapy for newly diagnosed breast cancer. Tumor derived exosome analysis may be a novel diagnostic and prognostic biosignature in breast cancer, which could prove to be a tool for earlier diagnosis, more effective treatments, and improved markers of response in order to increase survival rates.

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Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast cancer patients

Newly diagnosed patients with breast cancer presenting with operable breast tumor prior to initiation of of neoadjuvant chemotherapy (choice of chemotherapy will be the the treating physician's discretion)

No interventions assigned to this group

Healthy volunteers

Adult women without a cancer diagnosis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Women with biopsy proven invasive carcinoma of the breast
* Women with locally advanced breast cancer and breast tumors measuring \>/= 2cm who are deemed candidates for preoperative chemotherapy
* Age \>/= 18 years old
* Expected survival \>/= 6 months
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at initiation of study
* Initial required laboratory values:

Absolute neutrophil count \>/= 1.5 x 10(9)/L Platelet count \>/= 100,000 x 10(9)/L Creatinine clearance \>/= 50mL/min (calculated by Cockcroft-Gault method) Liver function tests (AST, ALT, total bilirubin) \</= 2.5 x ULN Urine or serum HCG negative (if female of childbearing potential)

* Women may be enrolled on ongoing therapeutic preoperative chemotherapy trials

Exclusion Criteria

* No prior chemotherapy for breast cancer
* No limitations for prior radiation therapy
* No active, serious infection or medical or psychiatric illness likely to interfere with participation in this trial
* Non-pregnant and non-nursing patients only. Patients of reproductive potential must agree to use an effective means of birth control
* No prior liver transplant or bone marrow transplant

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes