Trastuzumab and Letrozole in Treating Postmenopausal Women With Progressive Advanced Breast Cancer
- Registration Number
- NCT00238290
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief Summary
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving trastuzumab together with letrozole after disease progression may be an effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well giving trastuzumab together with letrozole works in treating postmenopausal women with progressive advanced breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the efficacy of trastuzumab (Herceptin®) monotherapy followed by trastuzumab and letrozole in women with progressive advanced breast cancer that is resistant to prior treatment with a nonsteroidal aromatase inhibitor.
Secondary
* Determine the safety profile of this regimen in these patients.
* Correlate HER-2-extracellular domain (ECD) levels with response to treatment in these patients.
* Determine the efficacy of this regimen in these patients.
* Correlate response and time to tumor progression with changes in serum HER-2-ECD levels in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes once in weeks 1-3 OR once in week 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression after 9 weeks receive trastuzumab as before and oral letrozole once daily in the absence of further disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 12 weeks until disease progression and then at 6 months.
PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A Trastuzumab + Letrozole Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes once in weeks 1-3 OR once in week 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression after 9 weeks receive trastuzumab as before and oral letrozole once daily in the absence of further disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Objective response rate as assessed by CT scan or MRI every 3 months 3 months
- Secondary Outcome Measures
Name Time Method Time to tumor progression (TTP) every 3 months 3 months Toxicity every 3 months 3 months Overall survival every 3 months 3 months
Trial Locations
- Locations (14)
Kantonsspital Bruderholz
🇨🇭Bruderholz, Switzerland
Ospedale Beata Vergine
🇨🇭Mendrisio, Switzerland
Saint Claraspital AG
🇨🇭Basel, Switzerland
Inselspital Bern
🇨🇭Bern, Switzerland
Kantonsspital Liestal
🇨🇭Liestal, Switzerland
Praxis Dr. Beretta
🇨🇭Rheinfelden, Switzerland
City Hospital Triemli
🇨🇭Zurich, Switzerland
UniversitaetsSpital Zuerich
🇨🇭Zurich, Switzerland
Universitaetsspital-Basel
🇨🇭Basel, Switzerland
Kantonsspital Graubuenden
🇨🇭Chur, Switzerland
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Kantonsspital - St. Gallen
🇨🇭St. Gallen, Switzerland
Kantonspital Aarau
🇨🇭Aarau, Switzerland
Kantonsspital Baden
🇨🇭Baden, Switzerland