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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01344109

Enrollment

Registered

2011-04-28

Start date

2011-02-28

Completion date

2014-12-31

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
To characterize protein surface markers and RNA profiles in tumor derived exosomes from breast cancer patients undergoing neoadjuvant chemotherapy	up to 2 years from start of study	Compare tumor derived exosomes at baseline, monthly during chemotherapy, at the completion of chemotherapy treatment, and after surgery to determine residual cancer burden. Tumor derived exosome expression will be correlated with both clinical and pathologic response.

Countries

United States

Outcome results