Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Breast Neoplasms

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    January 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    28 Patients enrolled

    Trial Details

    Trial ID

    NCT00708214

    Start Date

    January 1 2007

    Last Update

    December 30 2013

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    1200.5.3306A Boehringer Ingelheim Investigational Site

    Caen, France

    2

    1200.5.3304A Boehringer Ingelheim Investigational Site

    Nice, France

    3

    1200.5.3301A Boehringer Ingelheim Investigational Site

    Paris, France

    4

    1200.5.3305A Boehringer Ingelheim Investigational Site

    Paris, France