Spots Global Cancer Trial Database for Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer
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Trial Identification
Brief Title: Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer
Official Title: 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
Study ID: NCT01206881
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Aarhus University Hospital, Aarhus, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Herlev Hospital, Herlev, , Denmark
Odense University Hospital, Odense, , Denmark
Contact Details
Name: Malgorzata K Tuxen, MD
Affiliation: Herlev Hospital, Department of Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Ulla B Tange, MD
Affiliation: Rigshospitalet, Denmark
Role: PRINCIPAL_INVESTIGATOR
Name: Soeren Cold, MD
Affiliation: Odense University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Susanne B Søndergaard, MD
Affiliation: Herlev Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Henrik Petersen, MD
Affiliation: Odense University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Inger Hoejris, MD
Affiliation: Aarhus University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Anni Eskild-Jensen, MD
Affiliation: Aarhus University Hospital
Role: PRINCIPAL_INVESTIGATOR
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