Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00482391
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • trastuzumab — BIOLOGICAL
  • cyclophosphamide — DRUG
  • doxorubicin hydrochloride — DRUG
  • lapatinib ditosylate — DRUG
  • paclitaxel — DRUG
  • laboratory biomarker analysis — OTHER

Study Details

The purpose of this study is to study a new treatment for HER-2/neu (+) breast cancer.

Key Dates

Start date
Mar 31, 2007
Status verified
Apr 2017
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

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

Arms

  • Experimental: AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
    The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.

Primary Outcome Measure

Number of Patients Who Completed All Planned Therapy [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBostonMassachusetts02115-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10021-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute· Boston, MAMemorial Sloan-Kettering Cancer Center· New York, NY

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