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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-28

Study Completion Date

2010-07-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pegylated liposomal doxorubicin

Intervention Type DRUG

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pegylated liposomal doxorubicin

Intervention Type DRUG

Other Intervention Names

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Caelyx

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No