Neoplasms

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Breast Neoplasms

Breast Diseases

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Amino Acids

Afatinib

Tyrosine Kinase Inhibitors

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Tyrosine

BIBW 2992

Boehringer Ingelheim

The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.

An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer

An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen

OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.

CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.

CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.

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 1.0 criteria.

Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.

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 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.

OS is defined as time from randomisation to death.

LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as \>=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.

Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).

Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.

Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)

Cohort A

Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd

Cohort B

Total

Age, Continuous

Sex: Female, Male

Boehringer Ingelheim Call Center

With CB

Without CB

missing

TS. No data for Cohort A as CB was secondary endpoint only for Cohort B.

Clinical Benefit (CB)

TS. Median time to OR was not calcuable as there was no OR observed.

Time to OR

TS. Median duration of OR was not calcuable as there was no OR observed.

Duration of OR

Progression-free Survival (PFS)

Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication. No data for Cohort A as OR was primary endpoint only for Cohort B.

Objective Response (OR)

TS. No data for Cohort B as CB was primary endpoint only for Cohort A.

TS. As only 9 patient (31 percent) of Cohort A had died the median OS time was not estimable for Cohort A.

Spots Global Cancer Trial Database for An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer

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