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Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00128778
First received: August 9, 2005
Last updated: September 4, 2007
Last verified: September 2007
History of Changes
  Purpose

This is a randomized, prospective and multicenter phase IV clinical trial, which has been designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be recruited in the study.


Condition Intervention Phase
Breast Neoplasms
 Drug: Pegylated liposomal doxorubicin (Caelyx)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV.III Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs. Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Time to disease progression with maintenance Caelyx versus observation

Secondary Outcome Measures:
  • Assessment of single nucleotide polymorphisms (SNPs) for XPD, tubulin III, ERCC-1

Estimated Enrollment: 154
Study Start Date: October 2002
Estimated Study Completion Date: December 2006
Detailed Description:

The main variable is time to disease progression. All patients must be treated with first line of induction chemotherapy, consisting of doxorubicin 75 mg/m2, day 1 every 3 weeks, and docetaxel, 100 mg/m2, day 1 every 3 weeks. Both drugs must be administered sequentially. Patients previously treated with anthracyclines must receive 2 courses of doxorubicin and 4 courses of docetaxel. Otherwise, patients will receive 3 courses of doxorubicin followed by 3 courses of docetaxel.

Patients with complete response, partial response or stable disease are eligible for GEICAM 2001-01 study.

The investigators assume that maintenance treatment with Caelyx will increase mean time to progression from 10, 46 months (observation) to 17, 43 months. Expected difference in mean time to progression is 6, 97 months (Hazard ratio = 0.6). With an alpha error of 0.01 (unilateral) and power of 80%, 77 patients per arm are needed, 154 patients in total.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent.
  • Patients with metastatic breast cancer who have responded to a first line induction chemotherapy treatment.
  • Age: at least 18 years old.
  • Performance status ECOG 0, 1, 2.
  • Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF).
  • Hematology: leucocytes >= 4 x 10^9/l; neutrophils >= 2.0 x 10^9/l; platelets >= 100 x 10^9/l; hemoglobin <= 10 g/dl.
  • Hepatic function: total bilirubin < 1 upper limit of normal (UNL); ASAT (SGOT) and ALAT (SGPT) < 2.5 UNL; alkaline phosphatase < 5 UNL. Patients with ASAT (SGOT) and ALAT (SGPT) > 1.5 UNL and alkaline phosphatase > 2.5 UNL are not eligible.
  • Renal function: creatinine < 175 mmol/l (2 mg/dl); creatinine clearance > 45 ml/min.

Exclusion Criteria:

  • Pregnant or lactating patients.
  • Previous cardiac dysfunction grade II or higher as per New York Heart Association, along with congestive cardiac failure.
  • Hypersensitivity to anthracyclines or Cremophor®.
  • Clinically significant hepatic dysfunction.
  • Current uncontrolled infection.
  • Mental confusion and lack of orientation.
  • Any circumstance precluding an adequate follow-up.
  • Radiotherapy in the previous 4 weeks.
  • Any other concurrent neoplasm, except for basal cell carcinoma or in situ carcinoma.
  • Symptomatic metastasis in the brain.
  • Previous radiotherapy radiating a third of haematopoietic centres.
  • Males.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128778

Locations
Spain
Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Schering-Plough
Investigators
Study Chair: Emilio Alba, MD., PhD. Spanish Breast Cancer Research Group (GEICAM)
  More Information

Additional Information:
Click here for more information about this study: GEICAM 2001-01  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00128778     History of Changes
Other Study ID Numbers: GEICAM 2001-01
Study First Received: August 9, 2005
Last Updated: September 4, 2007
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Breast Cancer Research Group:
Breast cancer
Metastases
Maintenance treatment

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
 Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013