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Phase II Trial of Caelyx and Cyclophosphamide in Metastatic Breast Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Breast Neoplasm

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Trial Information

Phase II Trial of Caelyx and Cyclophosphamide in Metastatic Breast Cancer

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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to response; Duration of response; Time to progression; Survival

Outcome 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.

Safety Issue:



Canada: Health Canada

Study ID:




Start Date:

March 2003

Completion Date:

September 2007

Related Keywords:

  • Breast Neoplasm
  • Breast Neoplasms
  • Neoplasms