Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
NCT ID: NCT00258960
Last Updated: 2023-04-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2006-02-15
2009-07-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
NCT00005980
Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients
NCT00128778
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer
NCT01998906
A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948)
NCT00779129
Liposomal Doxorubicin, Trastuzumab, and Docetaxel in HER2 Positive Metastatic Breast Cancer
NCT00377780
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Caelyx,Cyclophosphamide,Trastuzumab
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)
Liposomal Doxorubicin
Cyclophosphamide
Trastuzumab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Liposomal Doxorubicin
Cyclophosphamide
Trastuzumab
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with histologically confirmed breast cancer and overexpression of Her2neu.
* Age\> 18 years.
* Eastern Cooperative Oncology Group (ECOG) equal or \< 2.
* Patients have not been treated previously with chemotherapy for metastatic disease.
* Patients must have at least one measurable lesion according to RECIST criteria.
* Patients should have an adequate organ function to tolerate chemotherapy.
Exclusion Criteria
* Patients who are pregnant or lactating are not eligible.
* Hepatic disease.
* Not controlled active infection
* Symptomatic metastatic brain cancer
* Previous adjuvant treatment with anthracyclines with a total accumulated dose \> 300 mg/m2 (Doxorubicin) or \> 600 mg/m2 (Epirubicin)
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Schering-Plough
INDUSTRY
Spanish Breast Cancer Research Group
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Hospital Clínico Universitario San Carlos
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Fundación Hospital Alcorcón
Alcorcón, Madrid, Spain
Hospital Juan Canalejo
A Coruña, , Spain
Centro Oncológico Regional de Galicia
A Coruña, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital Puerta del Mar
Cadiz, , Spain
Hospital Provincial de Castellón
Castelló, , Spain
Complejo Hospitalario de Jaen
Jaén, , Spain
Hospital Xeral Calde de Lugo
Lugo, , Spain
Hospital Universitario Doce de Octubre
Madrid, , Spain
Hospital Clínico Universitario San Carlos
Madrid, , Spain
Hospital Nuestra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Martin M, Sanchez-Rovira P, Munoz M, Baena-Canada JM, Mel JR, Margeli M, Ramos M, Martinez E, Garcia-Saenz JA, Casado A, Jaen AM, Gonzalez-Farre X, Escudero MJ, Rodriguez-Martin C, Carrasco E; GEICAM. Pegylated liposomal doxorubicin in combination with cyclophosphamide and trastuzumab in HER2-positive metastatic breast cancer patients: efficacy and cardiac safety from the GEICAM/2004-05 study. Ann Oncol. 2011 Dec;22(12):2591-2596. doi: 10.1093/annonc/mdr024. Epub 2011 Mar 17.
Related Links
Access external resources that provide additional context or updates about the study.
Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GEICAM/2004-05
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.