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| Sponsors and Collaborators: |
Spanish Breast Cancer Research Group Schering-Plough |
|---|---|
| Information provided by: | Spanish Breast Cancer Research Group |
| ClinicalTrials.gov Identifier: | NCT00258960 |
Purpose
Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.
Sample size calculation will be done by means of Simon's method in 2 stages for phase II studies and will be based on the principal aim of the study (evaluation of the rate of objective response).
The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment when the rate of response targets be lower than 35 %. In this case, considering an alpha error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study would continue if more than 5 objective responses were found. The total number of patients to including in the study would be 44. The results will be significant if they find at least 20 objective responses.
Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Liposomal Doxorubicin Drug: Cyclophosphamide Drug: Trastuzumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase IV.II, Clinical Trial, With the Combination of Pegylated Liposomal Doxorubicin (Caelyx), Cyclophosphamide and Trastuzumab (Herceptin) in Patients With Metastatic Breast Cancer With Overexpression of HER2/Neu |
| Estimated Enrollment: | 49 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | July 2008 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Miguel Martín, MD., PhD | +34913303000 | mmartin@geicam.org |
| Spain, Madrid | |
| GEICAM (Spanish Breast Cancer Research Group) | Recruiting |
| San Sebastián de los Reyes, Madrid, Spain, 28700 | |
| Contact: María Dolores Briones, MD., PhD. +34916592870 lbriones@geicam.org | |
| Principal Investigator: Montserrat Muñoz, MD., PhD | |
| Principal Investigator: Manuel Ramos, MD, PhD | |
| Principal Investigator: Carlos Jara, MD., PhD | |
| Principal Investigator: Cesar Mendiola, MD., | |
| Principal Investigator: Lourdes Calvo, MD., PhD. | |
| Principal Investigator: Miguel Martín, MD., PhD | |
| Principal Investigator: Angels Arcusa, MD., PhD | |
| Principal Investigator: Mireia Margelí, MD, PhD | |
| Principal Investigator: J. Ramón Mel, MD., PhD | |
| Principal Investigator: Miguel Ángel Cruz, MD., PhD | |
| Principal Investigator: Francisco Lobo, MD., PhD | |
| Principal Investigator: Eduardo Martinez de Dueñas, MD., PhD | |
| Study Chair: | Miguel Martín, MD., PhD | Spanish Breast Cancer Reserach Group |
More Information
| Study ID Numbers: | GEICAM/2004-05 |
| Study First Received: | November 24, 2005 |
| Last Updated: | September 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00258960 |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
HER2 positive breast cancer Metastatic breast cancer |
|
Skin Diseases Trastuzumab Breast Neoplasms |
Cyclophosphamide Doxorubicin Breast Diseases |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |
