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Sponsored by: |
Grupo Espanol de Estudio, Tratamiento y Otras Estrategias Experimentales en Tumores Solidos |
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Information provided by: | Grupo Espanol de Estudio, Tratamiento y Otras Estrategias Experimentales en Tumores Solidos |
ClinicalTrials.gov Identifier: | NCT00563953 |
This is a multicenter study of a primary chemotherapy regimen in breast cancer patients at risk of developing cardiotoxicity. The aim of the study is to evaluate the response rate at surgery.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Liposomal pegylated doxorubicine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II, Open-Label, Multicenter Clinical Trial of Pegylated Liposomal Doxorubicin (Caelyx®) as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease or Age Over 65 Years. |
Estimated Enrollment: | 66 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | March 2009 |
Arms | Assigned Interventions |
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1: Experimental
Primary chemotherapy regimen consisting of four cycles of pegylated-liposomal doxorubicine at 35 mg/m² IV plus CPM 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery.
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Drug: Liposomal pegylated doxorubicine
Four cycles of liposomal pegylated doxorubicine at 35 mg/m² IV combined with cyclophosphamide at 600 mg/m² on Day 1 every 4 weeks, and followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery.
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This is a phase II, uncontrolled, open label, multicenter study of a primary chemotherapy regimen consisting of four cycles of liposomal pegylated doxorubicine 35 mg/m² IV plus cyclophosphamide 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery in breast cancer patients at risk of developing anthracycline-induced cardiotoxicity.
Surgery (tumorectomy, quadrantectomy, or mastectomy plus lymphadenectomy) will be performed 2 to 5 weeks after the last primary chemotherapy infusion.
Patients with > 10% of hormone receptor-positive cells will receive appropriate hormone therapy according to menopausal status.
Patients treated with breast-conserving surgery will receive radiation therapy to the mammary gland.
Patients with T4 tumors or significant axillary involvement (≥ ypN2) will receive radiation therapy to the breast or chest wall and to the lymph node chains.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Hospital Universitari Vall d'Hebron | Recruiting |
Barcelona, Spain, 08035 | |
Contact: Carol Folch, Ms +34934894158 cafolch@vhebron.net | |
Principal Investigator: Meritxell Bellet, MD | |
Hospital de la Santa Creu i Sant Pau | Recruiting |
Barcelona, Spain, 08025 | |
Contact: Rosa Alfonso, Ms +34935537118 ralfonso@santpau.es | |
Principal Investigator: Belén Ojeda, MD | |
Hospital Universitari Arnau de Vilanova | Recruiting |
Lleida, Spain, 25198 | |
Contact: Laura Calabuig, Ms +34620589704 lcalabuig@arnau.scs.es | |
Principal Investigator: Antonio Llombart, MD | |
Hospital Universitario 12 de Octubre | Recruiting |
Madrid, Spain, 28041 | |
Contact: Ana Ferrero, Ms +34913908626 aferrero@h12o.es | |
Principal Investigator: Luis Manso, MD | |
Hospital Universitario Morales Meseguer | Recruiting |
Murcia, Spain, 30008 | |
Contact: Elena Garcia, MD +34968365209 | |
Principal Investigator: Elena García, MD | |
Hospital Clínico Universitario Lozano Blesa | Not yet recruiting |
Zaragoza, Spain, 50009 | |
Contact: Belén Martín, Ms onch-secret@hcu-lblesa.es | |
Principal Investigator: José I Mayordomo, MD | |
Spain, Barcelona | |
Institut Català d'Oncologia | Recruiting |
L'Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
Contact: Gema Berenger, Ms +34932607332 gberenguer@ico.scs.es | |
Principal Investigator: Miguel Gil, MD | |
Spain, Illes Balears | |
Hospital Son Llàtzer | Recruiting |
Palma de Mallorca, Illes Balears, Spain, 07198 | |
Contact: Araceli Rodriguez, Ms +34871202000 ext 2281 arodriguez2@hsll.es | |
Principal Investigator: Gustavo Catalán, MD |
Study Chair: | Miguel Gil, MD | Institut Català d'Oncologia |
Study ID Numbers: | SOLTI0702 |
Study First Received: | November 26, 2007 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00563953 |
Health Authority: | Spain: Spanish Agency of Medicines; Spain: Ethics Committee |
Breast Cancer Anthracyclines Cardiopathy |
Heart Diseases Skin Diseases Paclitaxel Breast Neoplasms |
Cyclophosphamide Doxorubicin Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Cardiovascular Diseases Antibiotics, Antineoplastic Pharmacologic Actions |