Safety Study of CAELYX in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines (Study P04057)(TERMINATED)

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: NCT00779285
Recruitment Status : Terminated
First Posted : October 24, 2008
Results First Posted : March 10, 2010
Last Update Posted : July 14, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to evaluate the cardiac safety of Caelyx in patients with metastatic breast cancer who have previously received chemotherapy with anthracyclines.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Drug: Pegylated Liposomal Doxorubicin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiac Safety Profile of Caelyx Therapy in Anthracyclin Pretreated Metastatic Breast Cancer Patients.
Study Start Date : February 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Single-arm
Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
Drug: Pegylated Liposomal Doxorubicin
Pegylated Liposomal Doxorubicin (Caelyx) IV, 50 mg/m2 once every 4 weeks for 6 cycles or until disease progression, whichever is earlier. Patients still receiving clinical benefit after a total of 6 cycles of Caelyx, may continue therapy at the discretion of the investigator.
Other Name: SCH 200746

Primary Outcome Measures :
  1. Cardiac Events [ Time Frame: Every 4 weeks during 6 cycles. ]
    A cardiac event was defined as a decrease in left ventricular ejection fraction (LVEF) of >=20 points from baseline if the resting LVEF remained in the normal range, or a decrease of >=10 points if the LVEF became abnormal (lower than the institutional lower limit of normal).

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

Inclusion Criteria:

  • Women with histologically or cytologically confirmed metastatic breast cancer (no prior chemotherapy for metastatic disease).
  • Prior treatment with an anthracyclin-containing regimen in the adjuvant setting (cumulative dose >240mg/m^2 and <360mg/m^2 doxorubicin or >430mg/m^2 and <650mg/m^2 epirubicin).
  • Women >18 years of age.
  • Documented measurable and/or evaluable metastatic breast cancer by appropriate radiological imaging (computed tomography (CT) scan and/or magnetic resonance imaging (MRI)).
  • Performance status of at least 60% (Karnofsky index) and a life expectancy of at least 12 weeks.
  • Left ventricular ejection fraction >50%.
  • Normal organ function, except if abnormal due to tumor involvement.

    • Adequate bone marrow function as indicated:

      • Platelets >100,000/mm^3
      • Hemoglobin >9 g/dL
      • Neutrophils >1,500/mm^3
    • Adequate renal function as indicated by:

      • Serum Creatinine <1.5 x the upper limit of normal
    • Adequate liver function, as indicated by:

      • Bilirubin and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2 times upper limit of normal (<4 times upper limit of normal when related to primary disease)
  • Subjects must be capable to demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
  • Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed intrauterine device (IUD), condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
  • Subjects must understand and be able to adhere to the dosing and visit schedules.

Exclusion Criteria:

  • Patient is pregnant or is breastfeeding.
  • Patients with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).
  • Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing Cremophor® EL (e.g., cyclosporin for injection concentrate and teniposide for injection concentrate).
  • Prior chemotherapy for metastatic disease.
  • Clinically significant hepatic disease (except liver metastases of primary disease).
  • Uncontrolled bacterial, viral, or fungal infection.
  • Radiotherapy in the last 4 weeks or prior radiation therapy to more than one-third of the hemopoietic sites.
  • Any other currently known malignancy or pre-malignant lesions or any history of other malignancy within the past five years (except non-melanoma skin cancer and surgically cured cervical cancer).
  • Symptomatic brain metastasis.
  • Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care.
  • Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease.
  • Documented human immunodeficiency virus (HIV) infection.
  • Any condition (medical, social, psychological) which would prevent adequate follow-up.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00779285     History of Changes
Other Study ID Numbers: P04057
EUDRACT NO. 2004-001177-25
First Posted: October 24, 2008    Key Record Dates
Results First Posted: March 10, 2010
Last Update Posted: July 14, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action