Lapatinib and Tamoxifen in Treating Patients With Advanced or Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00424164
- Brief 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.
- Detailed Description
OBJECTIVES:
Primary
* Determine the pharmacokinetics of lapatinib ditosylate and tamoxifen citrate in patients with advanced or metastatic breast cancer.
Secondary
* Assess the safety of this regimen in these patients.
* Determine any relationship between drug exposure and adverse events or biological modifications of this regimen in these patients.
* Assess the antitumor activity of this regimen in patients with measurable disease.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral tamoxifen citrate on days 1-28 of course 1. In all subsequent courses, patients receive oral tamoxifen citrate and oral lapatinib ditosylate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive oral lapatinib ditosylate on days 1-14 of course 1. In all subsequent courses, patients receive oral lapatinib ditosylate and oral tamoxifen citrate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
In both treatment arms, blood is collected periodically during courses 1 and 2 for pharmacokinetic studies.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tamoxifen-lapatinib lapatinib ditosylate Tamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib. Lapatinib-tamoxifen tamoxifen citrate Lapatinib will be given alone for 2 weeks during cycle 1. As of cycle 2, you will receive the combined treatment Lapatinib and Tamoxifen Tamoxifen-lapatinib tamoxifen citrate Tamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib. Tamoxifen-lapatinib pharmacological study Tamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib. Lapatinib-tamoxifen lapatinib ditosylate Lapatinib will be given alone for 2 weeks during cycle 1. As of cycle 2, you will receive the combined treatment Lapatinib and Tamoxifen Lapatinib-tamoxifen pharmacological study 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 Measures
Name Time Method Pharmacokinetic profile of lapatinib ditosylate and tamoxifen citrate alone and in combination maximum 24h after the dose administered on Day 28
- Secondary Outcome Measures
Name Time Method Safety until disease progression or until the start of another treatment (average 2 months) Relationship between drug exposure and adverse events or biological modifications until disease progression or until the start of another treatment (average 2 months) Response in patients with measurable disease until disease progression or until the start of another treatment (average 2 months)
Trial Locations
- Locations (1)
Centre Regional Rene Gauducheau
🇫🇷Dijon, France