Status:
COMPLETED
Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Schering-Plough
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-90 years
Phase:
PHASE4
Brief Summary
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 st...
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...
Eligibility Criteria
Inclusion
- 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 Eastern Cooperative Oncology Group (ECOG) scale 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); aspartate aminotransferase (ASAT) (SGOT) and alanine aminotransferase (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
- 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.
Key Trial Info
Start Date :
October 28 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2010
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00128778
Start Date
October 28 2002
End Date
July 7 2010
Last Update
March 6 2023
Active Locations (1)
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1
Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700