Lapatinib and Tamoxifen in Treating Patients With Advanced or Metastatic Breast Cancer

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT00424164
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • lapatinib ditosylate — DRUG
  • tamoxifen citrate — DRUG
  • pharmacological study — OTHER

Study Details

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving lapatinib together with tamoxifen may be an effective treatment for breast cancer. PURPOSE: This randomized phase I trial is studying the side effects of lapatinib and tamoxifen in treating patients with advanced or metastatic breast cancer.

Key Dates

Start date
Nov 30, 2006
Status verified
Mar 2024
Primary completion
Jun 30, 2009
Completion
May 28, 2010

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tamoxifen-lapatinib
    Tamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib.
  • Experimental: Lapatinib-tamoxifen
    Lapatinib will be given alone for 2 weeks during cycle 1. As of cycle 2, you will receive the combined treatment Lapatinib and Tamoxifen

Primary Outcome Measure

Pharmacokinetic profile of lapatinib ditosylate and tamoxifen citrate alone and in combination [ Time Frame: maximum 24h after the dose administered on Day 28 ]

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