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Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer

NCT00256243 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-03-02

Study results available
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Summary

We proposed to use 4 cycles of AC q 2 weeks, as used in the dose dense adjuvant study with GM-CSF support on days 3-9 of the cycle. After the completion of AC we plan to administer paclitaxel and carboplatin weekly for a total of 12 doses with one week rest after every 3 weeks of treatment over 12 weeks. Patients who are her-2 over-expressors by FISH (fluorescence in situ hybridization) will also receive Trastuzumab with weekly carboplatin and paclitaxel as the combination TC±H has been found to be synergistic in advanced breast cancer with improved clinical outcome.

Conditions

Interventions

DRUG

Doxorubicin

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

DRUG

Cyclophosphamide

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

DRUG

Paclitaxel

80 mg/m2 IV over 1 hour once weekly for 9-12 doses beginning two weeks after completion of last AC dose

DRUG

Carboplatin

Area under the concentration curve (AUC) 2 IV once weekly for 9-12 doses beginning two weeks after completion of last AC dose

DRUG

GM-CSF

250 μg/mL IV on day 5-14 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide

DRUG

Trastuzumab

AUC 2 IV weekly for 12-16 doses beginning two weeks after completion of last AC dose

Sponsors & Collaborators

  • Rita Sanghvi, Mehta

    lead OTHER

Principal Investigators

  • Rita Mehta, MD · 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
2004-04-30
Primary Completion
2011-03-31
Completion
2012-07-31

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 NCT00256243 on ClinicalTrials.gov