Breast Cancer
Conditions
Brief summary
Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.
Detailed description
Upon determination of eligibility, all patients will be receive: Gemcitabine + Trastuzumab
Interventions
DRUGTrastuzumab
Trastuzumab
DRUGGemcitabine
Gemcitabine
Sponsors
Eli Lilly and Company
Genentech, Inc.
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: * Her-2 positive metastatic breast cancer confirmed by biopsy * Measurable disease * Able to perform activities of daily living without considerable * No previous chemotherapy with gemcitabine * No more than one prior chemotherapy regimen for metastatic breast cancer * Adequate bone marrow, liver and renal function * Normal heart function * Give written informed consent prior to entering this study.
Exclusion criteria
You cannot participate in this study if any of the following apply to you: * Received previous treatment with gemcitabine * History of brain metastases * Serious underlying medical conditions Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 18 Months | The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 21 Months | The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Overall Survival (OS) | 24 months | The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine/Trastuzumab All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 3 |
Baseline characteristics
| Characteristic | Gemcitabine/Trastuzumab |
|---|---|
| Age, Continuous | 57 years |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 41 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 | 41 / 41 |
| serious Total, serious adverse events | 14 / 41 |
Outcome results
Primary
Overall Response Rate (ORR)
The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 18 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gemcitabine/Trastuzumab | Overall Response Rate (ORR) | 30 percentage of participants |
Secondary
Overall Survival (OS)
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time frame: 24 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine/Trastuzumab | Overall Survival (OS) | 21 months |
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. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 21 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine/Trastuzumab | Progression Free Survival (PFS) | 4 months |