Phase IV.III Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs. Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients
18 Years
90 Years
Female
Breast Neoplasms
Trial Information
Phase IV.III Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs. Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to disease progression with maintenance Caelyx versus observation
Principal Investigator
Emilio Alba, MD., PhD.
Investigator Role:
Study Chair
Investigator Affiliation:
Spanish Breast Cancer Research Group (GEICAM)
Authority:
Spain: Spanish Agency of Medicines
Study ID:
GEICAM 2001-01
NCT ID:
NCT00128778
Start Date:
October 2002
Completion Date:
December 2006
Related Keywords:
- Breast Neoplasms
- Breast cancer
- Metastases
- Maintenance treatment
- Breast Neoplasms
- Neoplasms
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