A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948)

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. Identifier: NCT00779129
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : September 30, 2015
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
Women with metastatic breast cancer are usually treated with anthracyclines (ie, doxorubicin or epirubicin) but cardiac toxicity limits their use. The aim of this study is to evaluate the safety and efficacy of Caelyx in combination with cyclophosphamide in women with metastatic breast cancer who have received adjuvant anthracyclines with or without a taxane.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Drug: Pegylated Lyposomal Doxorubicin Drug: Cyclophosphamide Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Caelyx and Cyclophosphamide in Metastatic Breast Cancer
Study Start Date : March 2003
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single Arm
Caelyx 35 mg/m2 and Cyclophosphamide 600 mg/m2
Drug: Pegylated Lyposomal Doxorubicin
Caelyx 35 mg/m2 intravenously, on Day 1, every 3 weeks, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
Other Name: SCH 200746
Drug: Cyclophosphamide
Cyclophosphamide 600 mg/m2, intravenously, on Day 1, every 6 weeks, during 6 cycles (concomitantly with Caelyx). Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.

Primary Outcome Measures :
  1. Time to response; Duration of response; Time to progression; Survival [ Time Frame: With complete or partial response, subjects will be re-evaluated 4 weeks later to confirm the initial observation; Follow-up for a minimum of one year for survival. ]

Secondary Outcome Measures :
  1. Left ventricular ejection fraction (LVEF), (MUGA Scan); Radiological imaging; Examination of adverse events, laboratory data, vital signs [ Time Frame: LVEF following cycles 2, 4, 5, and 6 of study drug; Radiological imaging every 6 weeks. ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female, aged >=18 years.
  • Subject must have histologic diagnosis of breast carcinoma.
  • Subject must have documented measurable metastatic breast cancer by appropriate radiologic imaging.
  • Subject must have previous anthracyclin-based adjuvant regimen and disease-free status for at least one year following the completion of adjuvant therapy.
  • Subject must have ECOG performance status 0, 1, or 2.
  • Subject must have life expectancy > 6 months
  • Subject must have left ventricular ejection fraction >=55% as determined by MUGA scan.
  • Subject must have normal organ function, except if abnormal due to tumor involvement:

    • Adequate bone marrow function (platelets >=100 X 10^9/L, hemoglobin >=90 g/L, Neutrophils >=1.5 X 10^9/L)
    • Adequate renal function (serum creatinine < 2 X the upper limit of normal (ULN)
    • Adequate liver function (bilirubin < 2 times ULN, AST or ALT < 2 times ULN in the absence of liver metastasis, AST or ALT < 5 times ULN in the presence of liver metastasis.
  • Women of childbearing potential must be using adequate contraception and have a negative pregnancy test at the time of enrollment.
  • Subject must be able to understand and give informed consent.

Exclusion Criteria:

  • Age > 75 years old.
  • Subject who is pregnant or breastfeeding or is unwilling to use adequate contraception.
  • Subject who has had a previous chemotherapy for metastatic disease.
  • Subject who has history of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure.
  • Subject who has clinically significant hepatic disease in regard to Hepatitis B, Hepatitis C, cirrhosis, or other liver diseases unrelated to the underlying metastatic breast cancer.
  • Subject who has uncontrolled bacterial, viral, or fungal infection.
  • Subject who exhibits confusion or disorientation.
  • Subject with any condition which would prevent adequate follow-up.
  • Subject who has received radiotherapy in the last 4 weeks.
  • Subject with any other active primary tumor under treatment, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
  • Subject who has brain metastasis.
  • Subject who is not able to give informed consent.

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00779129     History of Changes
Other Study ID Numbers: P02948
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
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