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Neoadjuvant Treatment of Breast Cancer

NCT00254592 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-02-28

Study results available
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Summary

Study Aims

1. To measure the clinic response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2-4 cycles of biweekly doxorubicin, cyclophosphamide with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks).
2. To measure the microscopic pathological response rate of this regimen.
3. To measure toxicity and the delivered dose intensity of this regimen.
4. To assess the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients.
5. To determine whether the GM-CSF increases the post treatment dendritic cells (S100+) percentage in the tumor draining lymph node as compared to pretreatment S100+ cells.
6. To determine whether the patients with a higher percent S100+ have a better clinical, pathological response, Disease Free Survival (DFS), and overall Survival (OS).
7. To determine whether flow cytometry of dendritic cells performed post-treatment in blood sample shows an increase in dendritic cell population compared to pretreatment levels.

Conditions

Interventions

DRUG

Doxorubicin

60 mg/m2 IV, bolus once a day every 14 days x 2-4 cycles

DRUG

Cyclophosphamide

600 mg/m2 IV once a day every 14 days x 2-4 cycles

DRUG

Carboplatin

AUC 2 IV weekly for 9-12 doses beginning two weeks after completion of last AC dose

DRUG

Nab-paclitaxel

100 mg/m2 IV over 30 min weekly for 9-12 doses beginning two weeks after completion of last AC dose

DRUG

GM-CSF

250 μg/mL IV or on day 4-13 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide

DRUG

Trastuzumab

4mg/kg, and then2 mg/kg q wk IV weekly for 12-16 doses beginning two weeks after completion of last AC dose

DRUG

Bevacizumab

10mg/kg q 2 wks

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Rita Mehta, M.D. · Chao Family Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2013-09-04
Completion
2013-09-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00254592 on ClinicalTrials.gov