BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer
NCT ID: NCT00708214
Last Updated: 2013-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Study Groups
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BIBW 2992
To study BIBW 2992 in association with letrozole in hormonoresistant metastatic breast cancer
BIBW 2992
BIBW 2992 at high and medium dosages
Letrozole
Letrozole at standard dosage
Letrozole
Hormonotherapy for metastatic breast cancer
BIBW 2992
BIBW 2992 at high and medium dosages
Letrozole
Letrozole at standard dosage
Interventions
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BIBW 2992
BIBW 2992 at high and medium dosages
BIBW 2992
BIBW 2992 at high and medium dosages
Letrozole
Letrozole at standard dosage
Letrozole
Letrozole at standard dosage
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1200.5.3306A Boehringer Ingelheim Investigational Site
Caen, , France
1200.5.3304A Boehringer Ingelheim Investigational Site
Nice, , France
1200.5.3301A Boehringer Ingelheim Investigational Site
Paris, , France
1200.5.3305A Boehringer Ingelheim Investigational Site
Paris, , France
1200.5.3302A Boehringer Ingelheim Investigational Site
Saint-Cloud, , France
Countries
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References
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Gunzer K, Joly F, Ferrero JM, Gligorov J, de Mont-Serrat H, Uttenreuther-Fischer M, Pelling K, Wind S, Bousquet G, Misset JL. A phase II study of afatinib, an irreversible ErbB family blocker, added to letrozole in patients with estrogen receptor-positive hormone-refractory metastatic breast cancer progressing on letrozole. Springerplus. 2016 Jan 19;5:45. doi: 10.1186/s40064-015-1601-7. eCollection 2016.
Other Identifiers
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2006-002814-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1200.5
Identifier Type: -
Identifier Source: org_study_id