Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2) -Overexpressing Inflammatory Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325428
• Other study ID #: 1200.89
• Secondary ID: 2010-024454-10
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2011
• Last updated: January 13, 2016
• Start date: August 2011
• Est. completion date: November 2014

Study information

• Verified date: January 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Dept of Health and Ageing Therapeutic Goods AdminHong Kong: Department of HealthSouth Korea: Ministry of Food and Drug Safety (MFDS)Thailand: Food and Drug AdministrationTunisia: Ministry of Public HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer

2. Locally advanced or metastatic disease

3. Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)

4. For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment

5. Investigator-confirmed diagnosis of Inflammatory Breast Cancer

6. Must have biopsiable disease

Exclusion criteria:

1. Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)

2. Must not have received prior vinorelbine treatment

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Afatinib once daily (OD)
Patient to receive afatinib monotherapy until progression of their disease
• Vinorelbine Weekly
Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy

Locations

Country	Name	City	State
Australia	1200.89.61002 Boehringer Ingelheim Investigational Site	East Bentleigh	Victoria
Australia	1200.89.61003 Boehringer Ingelheim Investigational Site	Perth	Western Australia
Hong Kong	1200.89.85201 Boehringer Ingelheim Investigational Site	Hong Kong
Korea, Republic of	1200.89.82001 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1200.89.82002 Boehringer Ingelheim Investigational Site	Seoul
Thailand	1200.89.66002 Boehringer Ingelheim Investigational Site	Bangkok
Thailand	1200.89.66004 Boehringer Ingelheim Investigational Site	Bangkok
Thailand	1200.89.66003 Boehringer Ingelheim Investigational Site	Chiangmai
Thailand	1200.89.66001 Boehringer Ingelheim Investigational Site	Hat-Yai, Songkhla
Tunisia	1200.89.21601 Boehringer Ingelheim Investigational Site	Ariana
Tunisia	1200.89.21602 Boehringer Ingelheim Investigational Site	Sousse
United Kingdom	1200.89.44002 Boehringer Ingelheim Investigational Site	Bournemouth
United Kingdom	1200.89.44001 Boehringer Ingelheim Investigational Site	London
United Kingdom	1200.89.44003 Boehringer Ingelheim Investigational Site	London
United States	1200.89.10005 Boehringer Ingelheim Investigational Site	Durham	North Carolina
United States	1200.89.10001 Boehringer Ingelheim Investigational Site	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Hong Kong,  Korea, Republic of,  Thailand,  Tunisia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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).	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.	No
Primary	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).	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).	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.	No
Secondary	Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).	Objective response was defined on a patient level as a best response of CR or PR.	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.	No
Secondary	Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).	Objective response was defined on a patient level as a best response of CR or PR.	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.	No
Secondary	Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).	Objective response was defined on a patient level as a best response of CR or PR.	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.	No
Secondary	Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).	Objective response was defined on a patient level as a best response of CR or PR.	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.	No
Secondary	Part A: Duration of Unconfirmed Objective Response.	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)).	From first drug administration until end of Part A, up to 929 days.	No
Secondary	Part B: Duration of Unconfirmed Objective Response.	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).	From first drug administration until end of Part B, up to 929 days.	No
Secondary	Part A: Progression Free Survival.	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.	From first drug administration until end of Part A, up to 713 days.	No
Secondary	Part B: Progression Free Survival.	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.	From first drug administration until end of Part B, up to 230 days.	No
Secondary	Progression Free Survival Over the Whole Sudy.	PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD.	From first drug administration until end of study, up to 700 days.	No

External Links

•   Link