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A Phase II Study of BIBW 2992 Administration in Patients With Hormone Refractory Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Neoplasms

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Trial Information

A Phase II Study of BIBW 2992 Administration in Patients With Hormone Refractory Metastatic Breast Cancer

Inclusion Criteria

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

1. Increase in the number of bone lesions on bone scan or on MRI AND/OR

2. Increased pain in an area of known bony metastasis AND superior or equal to 2 serial
elevations in CA 15.3 AND/OR

3. 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is the progression free rate after 16 weeks of treatment

Outcome Time Frame:

16 weeks

Safety Issue:


Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals


France: Agence Française de Sécurité Sanitaire des Produits de Santé

Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms