Skip to main content
OpenTrials
Completed

NCT Number: NCT00708214

BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

1200.5.3306A Boehringer Ingelheim Investigational Site, Caen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BIBW 2992

Drug

BIBW 2992 at high and medium dosages

letrozole

Drug

Letrozole at standard dosage

Primary outcomes

  1. Percentage of Progression Free Participants After 16 Weeks of Treatment

    Time frame: 16 weeks

    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.

Secondary outcomes

  1. Number of Participants With Confirmed Objective Response (OR)

    Time frame: Baseline till progression

    OR was defined as complete response (CR) or partial response (PR) and was assessed according to RECIST criteria regardless of treatment status.

  2. Number of Participants With Clinical Benefit (CB)

    Time frame: 16 weeks and 24 weeks

    CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.

  3. Time to RECIST Tumour Reponse

    Time frame: Baseline till progression

    The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.

  4. Duration of Confirmed OR

    Time frame: First occurence or OR till progression or death

    Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).

  5. Progression-free Survival (PFS)

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

    PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. Progression was assessed according to RECIST criteria.

  6. Overall Survival (OS)

    Time frame: Baseline till progression, death or data cut-off

    OS was defined as the time from first treatment to death.

  7. Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)

    Time frame: 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing

    AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau at steady state.

  8. Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)

    Time frame: 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing

    Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state.

  9. Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 57 (Cpre,ss,57)

    Time frame: Day 57

    Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57.

  10. Pre-dose Concentration of Afatinib in Plasma at Steady Stateon Day 85 (Cpre,ss,85)

    Time frame: Day 85

    Cpre,ss,85 represents the pre-dose concentration of afatinib in plasma at steady state on day 85.

  11. Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)

    Time frame: 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing

    tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state

  12. Area Under Curve of Letrozole Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)

    Time frame: 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing

    AUC0-tau,ss represents the area under the concentration curve of letrozole in plasma over a uniform dosing interval tau at steady state.

  13. Maximum Concentration of Letrozole in Plasma at Steady State (Cmax,ss)

    Time frame: 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing

    Cmax,ss represents the maximum measured concentration of letrozole in plasma at steady state.

  14. Time From Dosing to the Maximum Concentration of Letrozole in Plasma at Steady State (Tmax,ss)

    Time frame: 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing

    tmax,ss represents the time from dosing to the maximum concentration of letrozole in plasma at steady state.

  15. Change From Baseline in Ca15.3

    Time frame: baseline and day 29

    Change from baseline in Ca15.3 tumor marker levels

  16. Best Change From Baseline in ECOG Performance Status

    Time frame: baseline till end of treatment

    Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead). Improvement is a decrease in ECOG score from baseline of at least 1. Deterioration is an increase in ECOG score from baseline of at least 1

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
First posted
Jul 2, 2008
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.