Phase 2
Completed N=28
BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00708214 ↗Enrolled (actual)
28
Serious AEs
32.1%
Results posted
Nov 2013
Primary outcomePrimary: Percentage of Progression Free Participants After 16 Weeks of Treatment — 28.57; 0.00; 25.00 Percentage of participants
Summary
Progression-free rate after 16 weeks of BIBW 2992 administration in association with letrozole
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Progression Free Participants After 16 Weeks of Treatment |
28.57; 0.00; 25.00 | — |
| SECONDARY Number of Participants With Confirmed Objective Response (OR) |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinical Benefit (CB) |
2; 2; 2; 2; 0; 2 | — |
| SECONDARY Time to RECIST Tumour Reponse |
NA; NA; NA | — |
| SECONDARY Duration of Confirmed OR |
NA; NA; NA | — |
| SECONDARY Progression-free Survival (PFS) |
60.0; 107.0; 79.0 | — |
| SECONDARY Overall Survival (OS) |
NA; NA; NA | — |
| SECONDARY Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss) |
660; 579 | — |
| SECONDARY Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss) |
43.8; 33.9 | — |
| SECONDARY Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 57 (Cpre,ss,57) |
21.4; 15.8 | — |
| SECONDARY Pre-dose Concentration of Afatinib in Plasma at Steady Stateon Day 85 (Cpre,ss,85) |
16.9; 17.3 | — |
| SECONDARY Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss) |
2.00; 4.00 | — |
| SECONDARY Area Under Curve of Letrozole Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss) |
2420 | — |
| SECONDARY Maximum Concentration of Letrozole in Plasma at Steady State (Cmax,ss) |
135 | — |
| SECONDARY Time From Dosing to the Maximum Concentration of Letrozole in Plasma at Steady State (Tmax,ss) |
1.00 | — |
| SECONDARY Change From Baseline in Ca15.3 |
-4.35 | — |
| SECONDARY Best Change From Baseline in ECOG Performance Status |
4; 6; 16; 2 | — |
Eligibility 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:
- 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)
Data sourced from ClinicalTrials.gov (NCT00708214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.