Clinical trial NCT00950742: Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.
Official title: Phase I Open Label Trial to Assess Safety of BIBW 2992 in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-08-03
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®


Eligibility criteria: Inclusion criteria:

1. Female patients aged \>18 years.
2. 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.

Exclusion criteria:

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.

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities (DLT)
timeFrame: 28 days
measure: Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R)
timeFrame: 28 days
Secondary outcomes:
measure: Number of Patients With Objective Response (OR)
timeFrame: Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.
measure: Number of Patients With Best Overall Response
timeFrame: Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.
measure: Progression Free Survival (PFS)
timeFrame: Baseline until disease progression, death or data cut-off.
measure: Summary of Concentration of Afatinib in Plasma
timeFrame: 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing
measure: Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)
timeFrame: 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing
measure: Summary of Concentration of Herceptin in Plasma
timeFrame: 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: 1200.68.44001 Boehringer Ingelheim Investigational Site
city: Cambridge
country: United Kingdom
facility: 1200.68.44003 Boehringer Ingelheim Investigational Site
city: Guildford
country: United Kingdom
facility: 1200.68.44005 Boehringer Ingelheim Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: 1200.68.44004 Boehringer Ingelheim Investigational Site
city: Truro
country: United Kingdom
facility: 1200.68.44002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: