Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258960
• Other study ID #: GEICAM/2004-05
• Status: Completed
• Phase: Phase 2
• Start date: February 15, 2006
• Est. completion date: July 14, 2009

Study information

• Verified date: April 2023
• Source: Spanish Breast Cancer Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 14, 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Liposomal Doxorubicin

• Cyclophosphamide

• Trastuzumab

Locations

Country	Name	City	State
Spain	Fundación Hospital Alcorcón	Alcorcón	MAdrid
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
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	Centro Oncológico Regional de Galicia	La Coruña
Spain	Hospital Juan Canalejo	La Coruña
Spain	Hospital Xeral Calde de Lugo	Lugo
Spain	Hospital Clínico Universitario San Carlos	MAdrid
Spain	Hospital Universitario Doce de Octubre	MAdrid
Spain	Hospital Nuestra Señora de Candelaria	Santa Cruz De Tenerife

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Breast Cancer Research Group	Schering-Plough

Country where clinical trial is conducted

Spain, 

References & 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 cy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Progression (TTP)	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	Through study treatment, and follow up period, assessed up to 88 weeks
Secondary	Time to Treatment Failure (TTF)	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.	Through study treatment, and follow up period, assessed up to 88 weeks
Secondary	Response Duration	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.	Through study treatment, and follow up period, assessed up to 88 weeks
Secondary	Overall Survival (OS)	OS was defined as the time elapsed from first treatment until death from any cause.	Through study treatment, and follow up period, assessed up to 88 weeks

External Links

•   Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group