Lapatinib and Tamoxifen in Treating Patients With Advanced or Metastatic Breast Cancer
NCT00424164 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-03-08
Summary
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.
Conditions
Interventions
- DRUG
-
lapatinib ditosylate
- DRUG
-
tamoxifen citrate
- OTHER
-
pharmacological study
Sponsors & Collaborators
-
European Organisation for Research and Treatment of Cancer - EORTC
lead NETWORK
Principal Investigators
-
Pierre Fumoleau, MD, PhD · Centre Georges Francois Leclerc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-11-30
- Primary Completion
- 2009-06-30
- Completion
- 2010-05-28
Countries
- France
Study Locations
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