Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures

An open label, phase II trial of BIBW 2992 (afatinib) in patients with metastatic HER2-overexpressing breast cancer failing HER2-targeted treatment in the neoadjuvant and/or adjuvant treatment setting

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/07/001915

Enrollment

120

Registered

2011-07-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Breast Neoplasms

Interventions

Intervention1: Vinorelbine: In the study Vinorelbine 25 mg/m² i.v. once weekly may be given in the combination treatment part upon treatment failure on BIBW 2992 (afatinib) monotherapy. Treatment wil

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female patients with more than or equal to 18 years and less than or equal to 65 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer 2. Stage IV metastatic disease 3. At least one measurable lesion according to RECIST 1.1. Skin, bone and brain lesions are considered non-target lesions 4. Must have failed or progressed on either trastuzumab or lapatanib or trastuzumab and lapatanib treatment in the neoadjuvant and/or adjuvant setting

Exclusion criteria

Exclusion criteria: 1. Prior treatment with EGFR or HER2-targeted small molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or adjuvant setting 2. Prior treatment with paclitaxel in the past 12 months 3. Must not have received prior vinorelbine treatment 4. Platelet count 100 x 109/L for BIBW 2992 (afatinib) monotherapy

Design outcomes

Primary

Measure	Time frame
Objective Response (OR) assessed by RECIST 1.1Timepoint: 6 Weeks	—

Secondary

Measure	Time frame
Best overall response during each treatment period according to RECIST 1.1Timepoint: 6 Weeks;Duration of objective response, defined as the time from first objective response to the time of progression or death.Timepoint: 6 Weeks;Progression Free SurvivalTimepoint: 12 Months;Safety assessed by the severity and incidence of adverse event according to Common Terminology Criteria for Adverse Events (CTC s, AE Version 3.0), changes in vital signs and safety laboratory parametersTimepoint: 12 Months	—

Measure

Time frame

Best overall response during each treatment period according to RECIST 1.1Timepoint: 6 Weeks;Duration of objective response, defined as the time from first objective response to the time of progression or death.Timepoint: 6 Weeks;Progression Free SurvivalTimepoint: 12 Months;Safety assessed by the severity and incidence of adverse event according to Common Terminology Criteria for Adverse Events (CTC s, AE Version 3.0), changes in vital signs and safety laboratory parametersTimepoint: 12 Months

—

Countries

Austria, India, Singapore, Taiwan, United Kingdom

Contacts

Public ContactDr Partha Gokhale

Boehringer Ingelheim India Pvt. Ltd

sanjay.hake@boehringer-ingelheim.com02226456484

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026