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BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00708214
First received: June 30, 2008
Last updated: January 19, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
 Drug: BIBW 2992
Drug: Letrozole
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of BIBW 2992 Administration in Patients With Hormone Refractory Metastatic Breast Cancer

Resource links provided by NLM:

Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint is the progression free rate after 16 weeks of treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Occurence and intensity of adverse events graded according to CTCAE version 3.0 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 2. Objective response based on RECIST criteria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 3. Clinical benefit rate at 16 and 24 weeks based on RECIST criteria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 4. Time and duration of RECIST tumour response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 5. Progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2007
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBW 2992
To study BIBW 2992 in association with letrozole in hormonoresistant metastatic breast cancer
 Drug: BIBW 2992
BIBW 2992 at high and medium dosages
Drug: Letrozole
Letrozole at standard dosage
Letrozole
Hormonotherapy for metastatic breast cancer
 Drug: BIBW 2992
BIBW 2992 at high and medium dosages
Drug: Letrozole
Letrozole at standard dosage

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 as:

  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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708214

Locations
France
1200.5.3306A Boehringer Ingelheim Investigational Site
Caen Cedex, France
1200.5.3304A Boehringer Ingelheim Investigational Site
Nice Cedex 2, France
1200.5.3301A Boehringer Ingelheim Investigational Site
Paris Cedex 10, France
1200.5.3305A Boehringer Ingelheim Investigational Site
Paris Cedex 20, France
1200.5.3302A Boehringer Ingelheim Investigational Site
Saint Cloud, France
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00708214     History of Changes
Other Study ID Numbers: 1200.5, 2006-002814-37
Study First Received: June 30, 2008
Last Updated: January 19, 2012
Health Authority: France: Agence Française de Sécurité Sanitaire des Produits de Santé

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Letrozole
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013