Clinical trial NCT00826267: 6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
Official title: Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be obtained on the safety profile and pharmacokinetics of BIBW 2992.


Eligibility criteria: Inclusion criteria:

1. Female, age 18 years or older.
2. Histologically proven breast cancer who have not received any prior therapy.
3. Locally advanced disease Stage IIIa with no evidence of distant metastatic disease other than anatomical site lymph nodes.
4. HER2-positive.

Exclusion criteria:

1. Absolute neutrophil count (ANC) less than 1500/mm3.
2. Platelet count less than 100 000/ mm3.
3. Hemoglobin level less than 9.0 g/dl.
4. Bilirubin greater than 1.5 mg/dI.
5. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than twice the upper limit of normal.
6. Serum creatinine greater than 1.5 times of the upper normal limit.
7. Significant or recent acute gastrointestinal disorders with diarrhea
8. Pregnancy or breast-feeding.
9. Organ system dysfunction including cardiac (LVEF \< 50%).
10. Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with trastuzumab, EGFR, or EGFR/HER2-inhibitors.
11. Other malignancies diagnosed within the past five years.
12. Serious active infection. HIV, active hepatitis B or C.

Primary outcomes:
measure: Objective Response (OR)
timeFrame: Tumour assessments were performed at screening, day 22 and day 43.
Secondary outcomes:
measure: Number of Participants Who Achieved Clinical Benefit (CB)
timeFrame: Tumour assessments were performed at screening, day 22 and day 43.
measure: Change From Baseline in the Diameter of the Primary Target Lesion.
timeFrame: 3 weeks or 6 weeks
measure: Plasma Concentration of Afatinib
timeFrame: Day 7
measure: Changes in Biomarker in Tumour Biopsies
timeFrame: Screening, day 22, day 43
Other outcomes:
Locations:
city: Houston
country: United States
facility: 1200.44.01001 Boehringer Ingelheim Investigational Site
state: Texas
city: Brasilia
country: Brazil
facility: 1200.44.12008 Boehringer Ingelheim Investigational Site
city: Cachoeiro de Itapemirim
country: Brazil
facility: 1200.44.12011 Boehringer Ingelheim Investigational Site
city: Campo Grande
country: Brazil
facility: 1200.44.12012 Boehringer Ingelheim Investigational Site
city: Caxias do Sul
country: Brazil
facility: 1200.44.12009 Boehringer Ingelheim Investigational Site
city: Goiania
country: Brazil
facility: 1200.44.12010 Boehringer Ingelheim Investigational Site
city: Ijui
country: Brazil
facility: 1200.44.12005 Boehringer Ingelheim Investigational Site
city: Natal
country: Brazil
facility: 1200.44.12007 Boehringer Ingelheim Investigational Site
city: Novo Hamburgo
country: Brazil
facility: 1200.44.12004 Boehringer Ingelheim Investigational Site
city: Porto Alegre
country: Brazil
facility: 1200.44.12001 Boehringer Ingelheim Investigational Site
city: Porto Alegre
country: Brazil
facility: 1200.44.12013 Boehringer Ingelheim Investigational Site
city: Bogotá
country: Colombia
facility: 1200.44.14002 Boehringer Ingelheim Investigational Site
city: Cali
country: Colombia
facility: 1200.44.14001 Boehringer Ingelheim Investigational Site
city: Cercado
country: Peru
facility: 1200.44.19005 Boehringer Ingelheim Investigational Site
city: Lima
country: Peru
facility: 1200.44.19001 Boehringer Ingelheim Investigational Site
city: Lima
country: Peru
facility: 1200.44.19004 Boehringer Ingelheim Investigational Site
city: San Isidro
country: Peru
facility: 1200.44.19003 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: