Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
- Conditions
- Breast Neoplasms
- Interventions
- Registration Number
- NCT01325428
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer. The study will include patients who have and have not failed prior trastuzumab treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Afatinib once daily (OD) Vinorelbine Weekly Patients receive afatinib monotherapy once daily until progression of their disease Afatinib once daily (OD) Afatinib once daily (OD) Patients receive afatinib monotherapy once daily until progression of their disease
- Primary Outcome Measures
Name Time Method Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days. Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as \>182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as \>182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
- Secondary Outcome Measures
Name Time Method Part B: Progression Free Survival. From first drug administration until end of Part B, up to 230 days. PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study B.
Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. Objective response was defined on a patient level as a best response of CR or PR.
Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ). This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days. Objective response was defined on a patient level as a best response of CR or PR.
Part B: Duration of Unconfirmed Objective Response. From first drug administration until end of Part B, up to 929 days. Objective response was defined on a patient level as a best response of CR or PR. Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS).
Part A: Progression Free Survival. From first drug administration until end of Part A, up to 713 days. PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study A.
Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days. Objective response was defined on a patient level as a best response of CR or PR.
Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. Objective response was defined on a patient level as a best response of CR or PR.
Part A: Duration of Unconfirmed Objective Response. From first drug administration until end of Part A, up to 929 days. Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR). Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)).
Progression Free Survival Over the Whole Sudy. From first drug administration until end of study, up to 700 days. PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD.
Trial Locations
- Locations (16)
1200.89.21601 Boehringer Ingelheim Investigational Site
πΉπ³Ariana, Tunisia
1200.89.10005 Boehringer Ingelheim Investigational Site
πΊπΈDurham, North Carolina, United States
1200.89.61002 Boehringer Ingelheim Investigational Site
π¦πΊEast Bentleigh, Victoria, Australia
1200.89.10001 Boehringer Ingelheim Investigational Site
πΊπΈLos Angeles, California, United States
1200.89.66004 Boehringer Ingelheim Investigational Site
πΉπBangkok, Thailand
1200.89.85201 Boehringer Ingelheim Investigational Site
ππ°Hong Kong, Hong Kong
1200.89.61003 Boehringer Ingelheim Investigational Site
π¦πΊPerth, Western Australia, Australia
1200.89.66002 Boehringer Ingelheim Investigational Site
πΉπBangkok, Thailand
1200.89.82001 Boehringer Ingelheim Investigational Site
π°π·Seoul, Korea, Republic of
1200.89.66003 Boehringer Ingelheim Investigational Site
πΉπChiangmai, Thailand
1200.89.44001 Boehringer Ingelheim Investigational Site
π¬π§London, United Kingdom
1200.89.44002 Boehringer Ingelheim Investigational Site
π¬π§Bournemouth, United Kingdom
1200.89.44003 Boehringer Ingelheim Investigational Site
π¬π§London, United Kingdom
1200.89.82002 Boehringer Ingelheim Investigational Site
π°π·Seoul, Korea, Republic of
1200.89.21602 Boehringer Ingelheim Investigational Site
πΉπ³Sousse, Tunisia
1200.89.66001 Boehringer Ingelheim Investigational Site
πΉπHat-Yai, Songkhla, Thailand