Trial Outcomes & Findings for Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy (NCT NCT00431067)
NCT ID: NCT00431067
Last Updated: 2014-06-09
Results Overview
Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
From first dose of study medication to response measurement, up to 34 month
Results posted on
2014-06-09
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Other Adverse Event
|
9
|
|
Overall Study
Progressive disease
|
30
|
|
Overall Study
Non-compliance,lost to follow-up
|
2
|
Baseline Characteristics
Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy
Baseline characteristics by cohort
| Measure |
Afatinib 50 mg
n=41 Participants
Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
|
|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study medication to response measurement, up to 34 monthPopulation: Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.
Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .
Outcome measures
| Measure |
Afatinib 50 mg
n=41 Participants
Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
|
|---|---|
|
Objective Response (OR)
|
4 Participants
|
SECONDARY outcome
Timeframe: From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 monthPopulation: TS
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.
Outcome measures
| Measure |
Afatinib 50 mg
n=41 Participants
Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
|
|---|---|
|
Progression Free Survival (PFS)
|
106 days
Interval 57.0 to 117.0
|
SECONDARY outcome
Timeframe: From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 monthPopulation: TS (14 patients died)
OS was defined as the time from first treatment to death or to the last date the patient was known to be alive.
Outcome measures
| Measure |
Afatinib 50 mg
n=41 Participants
Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
|
|---|---|
|
Overall Survival (OS)
|
427 days
Interval 397.0 to
upper bound can not be calculated due to too few deaths.
|
SECONDARY outcome
Timeframe: From first dose of study medication to time when OR measurement was taken.Population: TS. There were only 4 patients who responded.
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.
Outcome measures
| Measure |
Afatinib 50 mg
n=41 Participants
Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
|
|---|---|
|
Time to RECIST Tumour Reponse
|
NA days
Median time of RECIST tumour response was not calculable as there were only 4 patients who responded.
|
SECONDARY outcome
Timeframe: From first OR to time of progression or deathPopulation: TS - patients with OR only.
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).
Outcome measures
| Measure |
Afatinib 50 mg
n=4 Participants
Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
|
|---|---|
|
Duration of Confirmed OR
|
153.3 days
Standard Deviation 162.2
|
Adverse Events
Afatinib 50 mg
Serious events: 8 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afatinib 50 mg
n=41 participants at risk
Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
2.4%
1/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Gastrointestinal disorders
Vomiting
|
7.3%
3/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Hepatobiliary disorders
Biliary colic
|
2.4%
1/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Infections and infestations
Diarrhoea infectious
|
2.4%
1/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Investigations
International normalised ratio decreased
|
2.4%
1/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
2/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.4%
1/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
4.9%
2/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.4%
1/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
2.4%
1/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
Other adverse events
| Measure |
Afatinib 50 mg
n=41 participants at risk
Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.1%
7/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Eye disorders
Keratoconjunctivitis sicca
|
7.3%
3/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
3/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Gastrointestinal disorders
Constipation
|
12.2%
5/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Gastrointestinal disorders
Diarrhoea
|
87.8%
36/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Gastrointestinal disorders
Dry mouth
|
22.0%
9/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
3/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Gastrointestinal disorders
Nausea
|
41.5%
17/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Gastrointestinal disorders
Oral pain
|
17.1%
7/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Gastrointestinal disorders
Stomatitis
|
36.6%
15/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Gastrointestinal disorders
Vomiting
|
34.1%
14/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
General disorders
Fatigue
|
46.3%
19/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
General disorders
Mucosal inflammation
|
12.2%
5/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
General disorders
Pyrexia
|
7.3%
3/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Infections and infestations
Localised infection
|
9.8%
4/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Investigations
Weight decreased
|
9.8%
4/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Metabolism and nutrition disorders
Anorexia
|
17.1%
7/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.3%
3/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.2%
5/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.8%
4/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
3/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Nervous system disorders
Dysgeusia
|
14.6%
6/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Nervous system disorders
Headache
|
9.8%
4/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Psychiatric disorders
Depression
|
7.3%
3/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.2%
5/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.1%
7/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.3%
3/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
17.1%
7/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.6%
6/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.2%
5/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
65.9%
27/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
12.2%
5/41 • From first dose of study medication to 28 days after study drug discontinuation.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER