Clinical trial · Interventional
Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients
Phase IV.III Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs. Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients
NCT00128778CI-TRIAL-00064447completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegylated liposomal doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: PLD
- description
- Pegylated liposomal doxorubicin (PLD) after induction chemotherapy in patients with metastatic breast cancer (MBC). Patients without disease progression following first-line induction chemotherapy consisting of three cycles of doxorubicin (75 mg/m2) followed by three cycles of docetaxel (100 mg/m2) both every 21 days, were randomized to PLD (40 mg/m2) every 28 days for six cycles or to observation.
- interventionNames
- Drug: Pegylated liposomal doxorubicin
- type
- NO_INTERVENTION
- label
- Arm B: Observation
- description
- Patients without disease progression following first-line induction chemotherapy consisting of three cycles of doxorubicin (75 mg/m2) followed by three cycles of docetaxel (100 mg/m2) both every 21 days, were randomized to observation.
Primary outcomes (1)
- measure
- Time to progression (TTP)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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 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 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.
References
Publications (1)
- RESULTAlba E, Ruiz-Borrego M, Margeli M, Rodriguez-Lescure A, Sanchez-Rovira P, Ruiz A, Mel-Lorenzo JR, Ramos-Vazquez M, Ribelles N, Calvo E, Casado A, Marquez A, Vicente D, Garcia-Saenz JA, Martin M. Maintenance treatment with pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer: GEICAM 2001-01 study. Breast Cancer Res Treat. 2010 Jul;122(1):169-76. doi: 10.1007/s10549-010-0860-9. Epub 2010 Apr 2. PMID 20361253