Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
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
1 other identifier
interventional
49
1 country
12
Brief Summary
Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Feb 2006
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2005
CompletedFirst Posted
Study publicly available on registry
November 28, 2005
CompletedStudy Start
First participant enrolled
February 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2009
CompletedResults Posted
Study results publicly available
July 15, 2019
CompletedApril 4, 2023
April 1, 2023
2.4 years
November 24, 2005
January 25, 2019
April 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
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.
Up to cycle 6 (24 weeks)
Secondary Outcomes (4)
Time to Progression (TTP)
Through study treatment, and follow up period, assessed up to 88 weeks
Time to Treatment Failure (TTF)
Through study treatment, and follow up period, assessed up to 88 weeks
Response Duration
Through study treatment, and follow up period, assessed up to 88 weeks
Overall Survival (OS)
Through study treatment, and follow up period, assessed up to 88 weeks
Study Arms (1)
Caelyx,Cyclophosphamide,Trastuzumab
OTHERCaelyx (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)
Interventions
Eligibility Criteria
You may qualify if:
- Patients must sign an informed consent before of specific procedures of clinical trial.
- 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.
You may not qualify if:
- Patients with hypersensitivity reactions to any of the medications of the clinical trial.
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spanish Breast Cancer Research Grouplead
- Schering-Ploughcollaborator
Study Sites (12)
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Fundación Hospital Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Juan Canalejo
A Coruña, 15006, Spain
Centro Oncológico Regional de Galicia
A Coruña, 15009, Spain
Hospital Clinic i Provincial
Barcelona, 08036, Spain
Hospital Puerta del Mar
Cadiz, 11009, Spain
Hospital Provincial de Castellón
Castelló, 12002, Spain
Complejo Hospitalario de Jaen
Jaén, 23007, Spain
Hospital Xeral Calde de Lugo
Lugo, 27004, Spain
Hospital Universitario Doce de Octubre
Madrid, 28021, Spain
Hospital Clínico Universitario San Carlos
Madrid, 28040, Spain
Hospital Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010, Spain
Related Publications (1)
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.
PMID: 21421542RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scientific Director / Medical Lead / Project Manager
- Organization
- Spanish Breast Cancer Research Group
Study Officials
- STUDY DIRECTOR
Study Director
Hospital Clínico Universitario San Carlos
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2005
First Posted
November 28, 2005
Study Start
February 15, 2006
Primary Completion
July 1, 2008
Study Completion
July 14, 2009
Last Updated
April 4, 2023
Results First Posted
July 15, 2019
Record last verified: 2023-04