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Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Brazil: National Health Surveillance Agency

Study ID:

1200.44

NCT ID:

NCT00826267

Start Date:

January 2009

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

1200.44.01001 Boehringer Ingelheim Investigational SiteHouston, Texas