A Phase II Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin (Caelyx) and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Patients With Locally Advanced Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Herlev Hospital
- Enrollment
- 45
- Locations
- 7
- Primary Endpoint
- clinical response rate
Study Overview
Brief Summary
The purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor > 5 cm.
Detailed Description
Patients with locally advanced or inflammatory breast cancer have a very bad prognosis. Several studies have shown that patients who receive a pathological complete response have the best prognosis. Neoadjuvant chemotherapy including anthracyclines and taxanes has become established as a standard option in the multidisciplinary management of this group of patients. In HER2 positive patients, chemotherapy in combination with trastuzumab is therapeutically attractive. Recent studies have also demonstrated that evaluation with PET-CT scan can be used to stratify treatment and monitor early response to neoadjuvant therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pathologically proven breast cancer
- •inflammatory, locally advanced breast cancer or a tumor > 5 cm
- •ECOG performance status < 2
- •LVEF > 50% measured by MUGA (HER2 positive patients)
- •adequate bone marrow, liver and renal function
- •written informed consent must be obtained
Exclusion Criteria
- •another malignancy within 5 years prior to study entry
- •concurrent treatment with an investigational agent
- •other disease or condition that contraindicates participation in the study
- •pregnant or lactating females
Outcomes
Primary Outcomes
clinical response rate
Time Frame: 24 weeks
evaluation of treatment efficacy every 2.cycle
Secondary Outcomes
- pathological response rate, response rate as defined by PET-CT scan, mammography and ultrasound, evaluation of toxicity of the combination regimen(up to 30 weeks)