Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients

NCT00128778 | Completed Phase 4

• 1 other identifier: GEICAM 2001-01
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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 study.

Conditions

Breast Neoplasms

Keywords

Breast cancer; Metastases; Maintenance treatment

Outcome Measures

Primary Outcomes (1)

• Time to progression (TTP)

  Tumor assessments will be performed until disease progression in order to evaluate the TTP. TTP is defined as the time from the date of the first dose to the first date of objectively determined progressive disease. For patients not known to have objectively-determined progressive disease, TTP will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression, TTP will be censored at the date of last objective progression-free assessment prior to the initiation of postdiscontinuation systemic anticancer therapy.

  Through study completion, an average of 1 year

Study Arms (2)

Arm A: PLD

EXPERIMENTAL

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.

Drug: Pegylated liposomal doxorubicin

Arm B: Observation

NO INTERVENTION

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.

Interventions

Pegylated liposomal doxorubicin DRUG

Also known as: Caelyx

Arm A: PLD

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Schering-Plough: collaborator

Study Sites (1)

Spanish Breast Cancer Research Group (GEICAM)

San Sebastián de los Reyes, Madrid, 28700, Spain

Location

Related Publications (1)

• Alba 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 RESULT

Related Links

• Click here for more information about this study

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

liposomal doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Hospital Universitario Virgen de la Victoria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2005
• First Posted: August 10, 2005
• Study Start: October 28, 2002
• Primary Completion: June 1, 2007
• Study Completion: July 7, 2010
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

ES (1)