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Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00258960
Recruitment Status : Completed
First Posted : November 28, 2005
Results First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Liposomal Doxorubicin Drug: Cyclophosphamide Drug: Trastuzumab Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 15, 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 14, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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)
 Drug: Liposomal Doxorubicin
Other Name: Caelyx

Drug: Cyclophosphamide
Other Name: Cytoxan

Drug: Trastuzumab
Other Name: Herceptin


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to cycle 6 (24 weeks) ]
    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.


Secondary Outcome Measures :
  1. Time to Progression (TTP) [ Time Frame: Through study treatment, and follow up period, assessed up to 88 weeks ]
    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

  2. Time to Treatment Failure (TTF) [ Time Frame: Through study treatment, and follow up period, assessed up to 88 weeks ]
    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.

  3. Response Duration [ Time Frame: Through study treatment, and follow up period, assessed up to 88 weeks ]
    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.

  4. Overall Survival (OS) [ Time Frame: Through study treatment, and follow up period, assessed up to 88 weeks ]
    OS was defined as the time elapsed from first treatment until death from any cause.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258960


Locations
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Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Fundación Hospital Alcorcón
Alcorcón, MAdrid, Spain, 28922
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital Puerta del Mar
Cadiz, Spain, 11009
Hospital Provincial de Castellón
Castelló, Spain, 12002
Complejo Hospitalario de Jaen
Jaén, Spain, 23007
Hospital Juan Canalejo
La Coruña, Spain, 15006
Centro Oncológico Regional de Galicia
La Coruña, Spain, 15009
Hospital Xeral Calde de Lugo
Lugo, Spain, 27004
Hospital Universitario Doce de Octubre
MAdrid, Spain, 28021
Hospital Clínico Universitario San Carlos
MAdrid, Spain, 28040
Hospital Nuestra Señora de Candelaria
Santa Cruz De Tenerife, Spain, 38010
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Schering-Plough
Investigators
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Study Director: Study Director Hospital Clínico Universitario San Carlos
More Information
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Additional Information:

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Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00258960    
Other Study ID Numbers: GEICAM/2004-05
First Posted: November 28, 2005    Key Record Dates
Results First Posted: July 15, 2019
Last Update Posted: July 15, 2019
Last Verified: April 2019
Keywords provided by Spanish Breast Cancer Research Group:
HER2 positive breast cancer
Metastatic breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Trastuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Immunological