Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.
Detailed description
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms: * Liposomal Doxorubicin * Docetaxel For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM, provided patient still meets the eligibility laboratory and performance status criteria. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
Interventions
DRUGLiposomal Doxorubicin
Liposomal Doxorubicin
DRUGDocetaxel
Docetaxel
Sponsors
Ortho Biotech, Inc.
Aventis Pharmaceuticals
SCRI Development Innovations, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in this study, you must meet the following criteria: * Metastatic breast cancer confirmed by biopsy * Prior adjuvant/neoadjuvant treatment allowed * Measurable disease * Able to perform activities of daily living with minimal assistance * Age 18 years or older * Adequate bone marrow, liver and kidney function * Normal heart function * Written informed consent
Exclusion criteria
You cannot participate in this study if any of the following apply to you: * Pre-existing moderate peripheral neuropathy * History of significant heart disease * Meningeal metastases. * Prior chemotherapy for metastatic breast cancer * No measurable disease (including bone only, pleural effusions, etc.) * Receiving Herceptin therapy. * Women who are pregnant or lactating. Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | 18 Months | ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. | 18 Months | PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A -Liposomal Doxorubicin Then Docetaxel Liposomal doxorubicin (Arm A)
Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.
Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria. | 50 |
| Arm B - Docetaxel Then Liposomal Doxorubicin Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.
Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria. | 52 |
| Total | 102 |
Baseline characteristics
| Characteristic | Total | Arm A -Liposomal Doxorubicin Then Docetaxel | Arm B - Docetaxel Then Liposomal Doxorubicin |
|---|---|---|---|
| Age Continuous | 62 years | 62 years | 62 years |
| Region of Enrollment United States | 102 participants | 50 participants | 52 participants |
| Sex: Female, Male Female | 102 Participants | 50 Participants | 52 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 50 | 35 / 52 |
| serious Total, serious adverse events | 18 / 50 | 22 / 52 |
Outcome results
Primary
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.
Time frame: 18 Months
Population: Patients who were removed from treatment before evaluation were not included in analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A -Liposomal Doxorubicin Then Docetaxel | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | 28 percentage of patients |
| Arm B - Docetaxel Then Liposomal Doxorubicin | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | 31 percentage of patients |
Secondary
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.
PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred.
Time frame: 18 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A -Liposomal Doxorubicin Then Docetaxel | Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. | 6.5 months |
| Arm B - Docetaxel Then Liposomal Doxorubicin | Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. | 5.5 months |