Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients
March 3, 2023 updated by: Spanish Breast Cancer Research Group
Phase IV.III Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs. Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
288
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Madrid
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San Sebastián de los Reyes, Madrid, Spain, 28700
- Spanish Breast Cancer Research Group (GEICAM)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Other Names:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to progression (TTP)
Time Frame: Through study completion, an average of 1 year
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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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Through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Study Director, Hospital Universitario Virgen de La Victoria
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 28, 2002
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
July 7, 2010
Study Registration Dates
First Submitted
August 9, 2005
First Submitted That Met QC Criteria
August 9, 2005
First Posted (Estimate)
August 10, 2005
Study Record Updates
Last Update Posted (Estimate)
March 6, 2023
Last Update Submitted That Met QC Criteria
March 3, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GEICAM 2001-01
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