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Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00258960
First received: November 24, 2005
Last updated: September 25, 2009
Last verified: September 2009
History of Changes
  Purpose

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

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.


Condition Intervention Phase
Breast Cancer
 Drug: Liposomal Doxorubicin
Drug: Cyclophosphamide
Drug: Trastuzumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV.II, Clinical Trial, With the Combination of Pegylated Liposomal Doxorubicin (Caelyx), Cyclophosphamide and Trastuzumab (Herceptin) in Patients With Metastatic Breast Cancer With Overexpression of HER2/Neu

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spanish Breast Cancer Research Group:

Primary Outcome Measures:
  • To evaluate objective response rate

Secondary Outcome Measures:
  • To evaluate the profile of toxicity
  • To evaluate time to progression
  • To evaluate overall survival
  • To determinate duration of response
  • To determinate time to failure of treatment

Estimated Enrollment: 49
Study Start Date: February 2006
Study Completion Date: July 2008
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must sign an informed consent before of especific procedures of clinical trial.
  • Patients with histologically confirmed breast cancer and overexpression of Her2neu.
  • Age> 18 years.
  • 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 adyuvant treatment with antrhacyclines with a total accumulated dose > 300 mg/m2 (Doxorubicin) or > 600 mg/m2 (Epirubicin)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258960

Locations
Spain
GEICAM (Spanish Breast Cancer Research Group)
San Sebastián de los Reyes, Madrid, Spain, 28703
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Schering-Plough
Investigators
Study Chair: Miguel Martín, MD., PhD Spanish Breast Cancer Reserach Group
  More Information

Additional Information:
(Click here for more information about this study: GEICAM/2004-05)  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00258960     History of Changes
Other Study ID Numbers: GEICAM/2004-05
Study First Received: November 24, 2005
Last Updated: September 25, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Breast Cancer Research Group:
HER2 positive breast cancer
Metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Trastuzumab
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on June 17, 2013