Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00258960|
Recruitment Status : Completed
First Posted : November 28, 2005
Results First Posted : July 15, 2019
Last Update Posted : July 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Liposomal Doxorubicin Drug: Cyclophosphamide Drug: Trastuzumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IV/II Trial With the Combination of Pegylated Liposomal Doxorubicin (Caelyx), Cyclophosphamide and Trastuzumab in Patients With Metastatic Breast Cancer With Overexpression of Human Epidermal Growth Factor Receptor 2 (HER2)/Neu|
|Actual Study Start Date :||February 15, 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 14, 2009|
Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
Drug: Liposomal Doxorubicin
Other Name: Caelyx
Other Name: Cytoxan
Other Name: Herceptin
- Objective Response Rate (ORR) [ Time Frame: Up to cycle 6 (24 weeks) ]ORR is the sum of the Complete Responses (CR) and Partial Responses (PR) according to the RECIST criteria, experienced for each patient during treatment (recorded from the start of the treatment until disease progression). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan (computed tomography) or MRI (magnetic resonance imaging): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.
- Time to Progression (TTP) [ Time Frame: Through study treatment, and follow up period, assessed up to 88 weeks ]TTP was defined as the time elapsed from first treatment until clinical evidence of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Time to Treatment Failure (TTF) [ Time Frame: Through study treatment, and follow up period, assessed up to 88 weeks ]TTF was defined as the time elapsed from first treatment until patient discontinuation due to toxicity, disease progression, death or withdrawal of consent for any reason, whichever occurred first.
- Response Duration [ Time Frame: Through study treatment, and follow up period, assessed up to 88 weeks ]Response duration was defined as the time elapsed from the first evidence of tumor response (Complete response or Partial Response) until clinical evidence of disease progression or death occurred.
- Overall Survival (OS) [ Time Frame: Through study treatment, and follow up period, assessed up to 88 weeks ]OS was defined as the time elapsed from first treatment until death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258960
|Hospital Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|
|Fundación Hospital Alcorcón|
|Alcorcón, MAdrid, Spain, 28922|
|Hospital Clinic i Provincial|
|Barcelona, Spain, 08036|
|Hospital Puerta del Mar|
|Cadiz, Spain, 11009|
|Hospital Provincial de Castellón|
|Castelló, Spain, 12002|
|Complejo Hospitalario de Jaen|
|Jaén, Spain, 23007|
|Hospital Juan Canalejo|
|La Coruña, Spain, 15006|
|Centro Oncológico Regional de Galicia|
|La Coruña, Spain, 15009|
|Hospital Xeral Calde de Lugo|
|Lugo, Spain, 27004|
|Hospital Universitario Doce de Octubre|
|MAdrid, Spain, 28021|
|Hospital Clínico Universitario San Carlos|
|MAdrid, Spain, 28040|
|Hospital Nuestra Señora de Candelaria|
|Santa Cruz De Tenerife, Spain, 38010|
|Study Director:||Study Director||Hospital Clínico Universitario San Carlos|