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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01325428




Registration number
NCT01325428
Ethics application status
Date submitted
28/03/2011
Date registered
29/03/2011
Date last updated
19/07/2016

Titles & IDs
Public title
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
Scientific title
An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer
Secondary ID [1] 0 0
2010-024454-10
Secondary ID [2] 0 0
1200.89
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Afatinib once daily (OD)
Treatment: Drugs - Vinorelbine Weekly

Experimental: Afatinib once daily (OD) - Patients receive afatinib monotherapy once daily until progression of their disease


Treatment: Drugs: Afatinib once daily (OD)
Patient to receive afatinib monotherapy until progression of their disease

Treatment: Drugs: Vinorelbine Weekly
Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
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).
Timepoint [2] 0 0
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.
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
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)).
Timepoint [5] 0 0
From first drug administration until end of Part A, up to 929 days.
Secondary outcome [6] 0 0
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).
Timepoint [6] 0 0
From first drug administration until end of Part B, up to 929 days.
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
From first drug administration until end of Part A, up to 713 days.
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
From first drug administration until end of Part B, up to 230 days.
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
From first drug administration until end of study, up to 700 days.

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
1200.89.61002 Boehringer Ingelheim Investigational Site - East Bentleigh
Recruitment hospital [2] 0 0
1200.89.61003 Boehringer Ingelheim Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
- East Bentleigh
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
Hong Kong
State/province [3] 0 0
Hong Kong
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul
Country [5] 0 0
Thailand
State/province [5] 0 0
Bangkok
Country [6] 0 0
Thailand
State/province [6] 0 0
Chiangmai
Country [7] 0 0
Thailand
State/province [7] 0 0
Hat-Yai, Songkhla
Country [8] 0 0
Tunisia
State/province [8] 0 0
Ariana
Country [9] 0 0
Tunisia
State/province [9] 0 0
Sousse
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Bournemouth
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01325428
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications