BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Breast Neoplasms

Treatments

Drug: BIBW 2992

Drug: Letrozole

Study type

Interventional

Funder types

Industry

Identifiers

1200.5

2006-002814-37 (EudraCT Number)

Details and patient eligibility

About

Progression-free rate after 16 weeks of BIBW 2992 administration in association with letrozole

Enrollment

28 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female patients with histologically proven breast adenocarcinoma
Presence of metastatic disease No more than 2 prior chemotherapy regimens for metastatic disease, which could include trastuzumab Patients must currently be on letrozole and developed acquired resistance as defined by disease progression on letrozole following previous response (partial response or better, stable disease superior or equal to 24 weeks)

Diagnosis of disease progression inferior or equal to 6 weeks prior to trial entrydefined as:

Increase in the number of bone lesions on bone scan or on MRI AND/OR
Increased pain in an area of known bony metastasis AND superior or equal to 2 serial elevations in CA 15.3 AND/OR
Progression according to RECIST criteria on CT scan, MRI, or x-ray Patients must have documented menopause confirmed by estradiol level inferior to 11 pg/ml

Exclusion criteria

Premenopausal patients
Rapidly progressive disease in major organs (i.e. lymphangitic spread in the lung and/or bulky liver metastasis) Patient with brain metastasis Significant cardiovascular diseases Previous treatment with an EGFR and/or HER-2 inhibiting drug(patients who received trastuzumab with chemotherapy but not with letrozole can be enrolled)