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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128778
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : February 21, 2019
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Pegylated liposomal doxorubicin Phase 4

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/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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV.III Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs. Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients
Actual Study Start Date : October 28, 2002
Actual Primary Completion Date : June 1, 2007
Actual Study Completion Date : July 7, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm A: PLD
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
Other Name: Caelyx

No Intervention: Arm B: Observation
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 Outcome Measures :
  1. Time to progression (TTP) [ Time Frame: Through study completion, an average of 1 year ]
    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.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128778

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Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700
Sponsors and Collaborators
Spanish Breast Cancer Research Group
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Study Director: Study Director Hospital Universitario Virgen de la Victoria
Additional Information:
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Responsible Party: Spanish Breast Cancer Research Group Identifier: NCT00128778    
Other Study ID Numbers: GEICAM 2001-01
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Keywords provided by Spanish Breast Cancer Research Group:
Breast cancer
Maintenance treatment
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action