Clinical trial NCT00258960: Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: HER2 positive breast cancer
Metastatic breast cancer
Lead sponsor: Spanish Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2005-11-28
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to cycle 6 (24 weeks)
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: Through study treatment, and follow up period, assessed up to 88 weeks
measure: Time to Treatment Failure (TTF)
timeFrame: Through study treatment, and follow up period, assessed up to 88 weeks
measure: Response Duration
timeFrame: Through study treatment, and follow up period, assessed up to 88 weeks
measure: Overall Survival (OS)
timeFrame: Through study treatment, and follow up period, assessed up to 88 weeks
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Alcorcón
country: Spain
facility: Fundación Hospital Alcorcón
state: MAdrid
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
city: Castelló
country: Spain
facility: Hospital Provincial de Castellón
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaen
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: La Coruña
country: Spain
facility: Centro Oncológico Regional de Galicia
city: Lugo
country: Spain
facility: Hospital Xeral Calde de Lugo
city: MAdrid
country: Spain
facility: Hospital Universitario Doce de Octubre
city: MAdrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Nuestra Señora de Candelaria
Study officials:
affiliation: Hospital Clínico Universitario San Carlos
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.