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Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer

NCT00404066 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-12-22

Study results available
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Summary

This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide (AC) followed by standard, every 3 week docetaxel and GW572016 (lapatinib) for neoadjuvant treatment of Her2neu positive stage II/III breast cancer. The purpose of the study was to determine whether lapatinib combined with chemotherapy was safe and resulted in an increase in pathologic complete response rates.

Conditions

Interventions

DRUG

Lapatinib

1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles)

DRUG

Doxorubicin

60 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with cyclophosphamide.

DRUG

Cyclophosphamide

600 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with doxorubicin.

DRUG

Docetaxel

100 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide

DRUG

Pegfilgrastim

6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments.

DRUG

Filgrastim

300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies.

DRUG

Dexamethasone

8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel

DRUG

Trastuzumab

Loading dose 8 mg/kg, then 6 mg/kg, intravenously every 3 weeks for 1 year

Sponsors & Collaborators

Principal Investigators

  • George A Fisher, MD, PhD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-12-31
Completion
2011-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00404066 on ClinicalTrials.gov