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

Part of paid clinical trials in San Jose, California.

Sponsor
George Albert Fisher
Study ID
NCT00404066
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG
    1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles)
  • Doxorubicin — DRUG
    60 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with cyclophosphamide.
  • Cyclophosphamide — DRUG
    600 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with doxorubicin.
  • Docetaxel — DRUG
    100 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
  • Pegfilgrastim — DRUG
    6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments.
  • Filgrastim — DRUG
    300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies.
  • Dexamethasone — DRUG
    8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel
  • Trastuzumab — DRUG
    Loading dose 8 mg/kg, then 6 mg/kg, intravenously every 3 weeks for 1 year

Study Details

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.

Key Dates

Start date
Oct 31, 2006
Status verified
Nov 2017
Primary completion
Dec 31, 2010
Completion
Mar 31, 2011

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Chemotherapy
    Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.

Primary Outcome Measure

Percentage of Participants With Pathologic Complete Response (pCR) [ Time Frame: 12 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Santa Clara Valley Medical CenterSan JoseCalifornia95128-
Stanford University School of MedicineStanfordCalifornia94305-

Find similar trials in San Jose, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Santa Clara Valley Medical Center· San Jose, CAStanford University School of Medicine· Stanford, CA

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