Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer

Herlev Hospital

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: pegylated liposomal doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT01206881

PO5903, EudraCT 2008-007951-29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)