Breast Neoplasms
Conditions
Brief summary
The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens.
Interventions
DRUGBIBW 2992
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: 1. Male or female patients with confirmed diagnosis of Stage IIIB or IV HER2-positive metastatic breast cancer(HER2 2+ and FISH positive or HER2 3+). 2. Patients must have progressed following receipt of prior standard trastuzumab treatment or standard chemotherapy in conjunction with trastuzumab. Patients with visceral disease or rapid progression should not be included if they have not had previous chemotherapy in addition to trastuzumab. Patients who are intolerant to trastuzumab and who have received adequate chemotherapy and/or hormone therapy are eligible upon progression. 3. Age 18 years or older. 4. Life expectancy of at least four (4) months. 5. Written informed consent that is consistent with ICH-GCP guidelines. 6. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2. 7. Patients should not have received treatment with chemotherapy or immune therapy within the last 4 weeks (2 weeks for trastuzumab). Patients should not have received treatment with hormone therapy within the last 2 weeks. 8. Patients must have recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC less than or equal to Grade 1. 9. Patients must have recovered from previous surgery. 10. Patients must have measurable disease as defined by RECIST criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response (OR) | From first dose of study medication to response measurement, up to 34 month | Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month | PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST criteria. |
| Overall Survival (OS) | From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month | OS was defined as the time from first treatment to death or to the last date the patient was known to be alive. |
| Time to RECIST Tumour Reponse | From first dose of study medication to time when OR measurement was taken. | The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria. |
| Duration of Confirmed OR | From first OR to time of progression or death | Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival). |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Afatinib 50 mg Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non-compliance,lost to follow-up | 2 |
| Overall Study | Other Adverse Event | 9 |
| Overall Study | Progressive disease | 30 |
Baseline characteristics
| Characteristic | Afatinib 50 mg |
|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 13.5 |
| 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 | 40 / 41 |
| serious Total, serious adverse events | 8 / 41 |
Outcome results
Primary
Objective Response (OR)
Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .
Time frame: From first dose of study medication to response measurement, up to 34 month
Population: Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Afatinib 50 mg | Objective Response (OR) | 4 Participants |
Secondary
Duration of Confirmed OR
Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).
Time frame: From first OR to time of progression or death
Population: TS - patients with OR only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Afatinib 50 mg | Duration of Confirmed OR | 153.3 days | Standard Deviation 162.2 |
Secondary
Overall Survival (OS)
OS was defined as the time from first treatment to death or to the last date the patient was known to be alive.
Time frame: From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month
Population: TS (14 patients died)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Afatinib 50 mg | Overall Survival (OS) | 427 days |
Secondary
Progression Free Survival (PFS)
PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST criteria.
Time frame: From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month
Population: TS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Afatinib 50 mg | Progression Free Survival (PFS) | 106 days |
Secondary
Time to RECIST Tumour Reponse
The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.
Time frame: From first dose of study medication to time when OR measurement was taken.
Population: TS. There were only 4 patients who responded.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Afatinib 50 mg | Time to RECIST Tumour Reponse | NA days |