BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer

NCT00708214 | Completed Phase 2 Results

• 2 other identifiers: 1200.52006-002814-37
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Percentage of Progression Free Participants After 16 Weeks of Treatment

  Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.

  16 weeks

Secondary Outcomes (16)

• Number of Participants With Confirmed Objective Response (OR)

  Baseline till progression

• Number of Participants With Clinical Benefit (CB)

  16 weeks and 24 weeks

• Time to RECIST Tumour Reponse

  Baseline till progression

• Duration of Confirmed OR

  First occurence or OR till progression or death

• Progression-free Survival (PFS)

  Baseline till progression, death or data cut-off (04 Jan 2010)

Study Arms (2)

BIBW 2992

EXPERIMENTAL

To study BIBW 2992 in association with letrozole in hormonoresistant metastatic breast cancer

Drug: BIBW 2992; Drug: Letrozole

Letrozole

OTHER

Hormonotherapy for metastatic breast cancer

Drug: BIBW 2992; Drug: Letrozole

Interventions

BIBW 2992 DRUG

BIBW 2992 at high and medium dosages

BIBW 2992

Letrozole DRUG

Letrozole at standard dosage

BIBW 2992

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (5)

1200.5.3306A Boehringer Ingelheim Investigational Site

Caen, France

Location

1200.5.3304A Boehringer Ingelheim Investigational Site

Nice, France

Location

1200.5.3301A Boehringer Ingelheim Investigational Site

Paris, France

Location

1200.5.3305A Boehringer Ingelheim Investigational Site

Paris, France

Location

1200.5.3302A Boehringer Ingelheim Investigational Site

Saint-Cloud, France

Location

Related Publications (1)

• 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.

  PMID: 26835225 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Afatinib; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 2, 2008
• Study Start: January 1, 2007
• Primary Completion: February 1, 2010
• Last Updated: December 30, 2013
• Results First Posted: November 19, 2013

Record last verified: 2013-10

Locations

FR (5)