Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.
Detailed description
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily
Interventions
DRUGImatinib
Imatinib
DRUGDocetaxel
Docetaxel
Sponsors
Novartis
Aventis Pharmaceuticals
SCRI Development Innovations, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 * No more than one prior chemotherapy regimen for metastatic breast cancer * Able to perform activities of daily living with minimal assistance * Adequate bone marrow, liver and kidney function * Age 18 years or older * Give written informed consent
Exclusion criteria
You cannot participate in this study if any of the following apply to you: * Moderate to severe peripheral neuropathy * Uncontrolled blood pressure or uncontrolled heart beat irregularities * Diabetes Mellitus with fasting blood sugar greater than 200 mg % * Significant heart disease within the prior 6 months * Severe or uncontrolled medical disease * Active uncontrolled infection * Known chronic liver disease * Known diagnosis of HIV infection * Pregnant or breast feeding females Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 18 months | Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 18 months | PFS defined as the length of time, in months, that patients were alive from date of first protocol treatment until worsening of disease, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. |
| Overall Survival (OS) | 18 months | Defined as the time from first protocol treatment to date of death due to any cause. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily. | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 59 years |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 37 / 37 |
| serious Total, serious adverse events | 18 / 37 |
Outcome results
Primary
Overall Response Rate (ORR)
Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Overall Response Rate (ORR) | 16 percentage of participants |
Secondary
Overall Survival (OS)
Defined as the time from first protocol treatment to date of death due to any cause.
Time frame: 18 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Overall Survival (OS) | 15.4 months |
Secondary
Progression Free Survival (PFS)
PFS defined as the length of time, in months, that patients were alive from date of first protocol treatment until worsening of disease, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: 18 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Progression Free Survival (PFS) | 9.3 Months |