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Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer

NCT00191789 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2010-07-27

Study results available
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Summary

Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.

Conditions

Interventions

DRUG

gemcitabine

1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8)

DRUG

doxorubicin

60 mg/m\^2, IV, every 21 days x 4 cycles (1-4)

DRUG

cisplatin

70 mg/m\^2, IV, every 21 days x 4 cycles (5-8)

PROCEDURE

surgery

Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT -5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • India

Study Locations

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Entities

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Diseases
Companies

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 NCT00191789 on ClinicalTrials.gov