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BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00708214
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : November 19, 2013
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: BIBW 2992 Drug: Letrozole Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of BIBW 2992 Administration in Patients With Hormone Refractory Metastatic Breast Cancer
Study Start Date : January 2007
Actual Primary Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00708214     History of Changes
Other Study ID Numbers: 1200.5
2006-002814-37 ( EudraCT Number: EudraCT )
First Posted: July 2, 2008    Key Record Dates
Results First Posted: November 19, 2013
Last Update Posted: December 30, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs