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Completed

NCT Number: NCT00258960

Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Liposomal Doxorubicin

Drug

Other names: Caelyx

Cyclophosphamide

Drug

Other names: Cytoxan

Trastuzumab

Drug

Other names: Herceptin

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Spanish Breast Cancer Research Group

Other

Collaborators

  • Schering-Plough

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Nov 28, 2005
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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