Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.
2 other identifiers
interventional
18
1 country
5
Brief Summary
Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2009
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedFirst Posted
Study publicly available on registry
August 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
October 17, 2013
CompletedFebruary 10, 2025
January 1, 2025
4.2 years
July 31, 2009
August 8, 2013
January 20, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Dose Limiting Toxicities (DLT)
Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.
28 days
Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R)
The MTD was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. It was determined using a standard 3 + 3 dose escalation cohort design. To confirm the MTD, the MTD cohort was to be expanded to 18 patients with no more than 3/18 patients experiencing a DLT. Please refer to CAVEATs and Limitations.
28 days
Secondary Outcomes (6)
Number of Patients With Objective Response (OR)
Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.
Number of Patients With Best Overall Response
Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.
Progression Free Survival (PFS)
Baseline until disease progression, death or data cut-off.
Summary of Concentration of Afatinib in Plasma
0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing
Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)
0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing
- +1 more secondary outcomes
Study Arms (1)
BIBW 2992 + Trastuzumab
EXPERIMENTALFind maximum tolerated dose of the non-marketed substance:BIBW 2992 given orally with fixed weekly infusion doses of 2mg/kg Herceptin. Escalating doses of BIBW 2992 starting at 20mg daily.
Interventions
Eligibility Criteria
You may qualify if:
- Female patients aged \>18 years.
- Advanced or metastatic breast cancer that over-expresses HER2 (immunohistochemistry 3+ or 2+ and gene amplification by FISH). Prior treatment with Herceptin® or Lapatinib® (in the adjuvant or metastatic settings) is permitted but not required.
You may not qualify if:
- Patients with untreated or symptomatic brain metastases. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before the start of therapy or concomitantly with this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
1200.68.44001 Boehringer Ingelheim Investigational Site
Brighton, United Kingdom
1200.68.44003 Boehringer Ingelheim Investigational Site
Cambridge, United Kingdom
1200.68.44005 Boehringer Ingelheim Investigational Site
Guildford, United Kingdom
1200.68.44004 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne, United Kingdom
1200.68.44002 Boehringer Ingelheim Investigational Site
Truro, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
MTD was determined at 20mg afatinib when 1/6 pat. had DLT (3+3 design). Upon expansion of MTD cohort to 18 pat. recruitment was stopped when 4/13 pat. had DLT. No lower afatinib dose could be tested as 20mg was the lowest dose formulation available.
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2009
First Posted
August 3, 2009
Study Start
August 1, 2009
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
February 10, 2025
Results First Posted
October 17, 2013
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency