6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: lapatinib; Drug: BIBW 2992; Drug: trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00826267

1200.44

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 3 patient groups

BIBW 2992

Experimental group

Description:

BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)

Treatment:

Drug: BIBW 2992

Lapatinib

Active Comparator group

Description:

Lapatinib tablets 1500 mg daily.

Treatment:

Drug: lapatinib

Trastuzumab

Active Comparator group

Description:

Trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly.

Treatment:

Drug: trastuzumab