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

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ClinicalTrials.gov Identifier: NCT01325428
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : February 11, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Neoplasms
Interventions: Drug: Afatinib once daily (OD)
Drug: Vinorelbine Weekly

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was an open-label study conducted in two sequential parts (Part A in which patients were treated with Afatinib (BIBW 2992) as monotherapy; Part B in which patients were treated with Afatinib plus Vinorelbine as combination therapy after progression on Afatinib monotherapy).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Part A: Patients were treated with Afatinib and could continue on treatment until first Progression of Disease (PD), intolerable side effects, or withdrawal of consent. Upon first PD, patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with weekly Vinorelbine.

Reporting Groups
  Description
Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B).

Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related adverse events (AEs), the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.

Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.


Participant Flow for 2 periods

Period 1:   Part A
    Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B).
STARTED   26 
COMPLETED   10 
NOT COMPLETED   16 
Progressive disease according to RECIST                9 
Clinical signs, symptoms of progression                2 
Other adverse event                1 
Refused continue taking trial medication                2 
Other reason not defined above                2 

Period 2:   Part B
    Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B).
STARTED   10 
COMPLETED   7 
NOT COMPLETED   3 
Refused continue taking trial medication                2 
Other reason not defined above                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

TRT A Treated set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.

TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.


Reporting Groups
  Description
Part A: Afatinib Once Daily. Part B: Afatinib+V (Vinorelbine).

Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.

Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.


Baseline Measures
   Part A: Afatinib Once Daily. Part B: Afatinib+V (Vinorelbine). 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
 
Part A   51.5  (8.8) 
Part B   51.5  (12.5) 
Gender, Customized 
[Units: Participants]
 
Female (Part A)   26 
Female (Part B)   10 
Male (Part A)   0 
Male (Part B)   0 


  Outcome Measures

1.  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).   [ Time Frame: 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. ]

2.  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).   [ Time Frame: 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. ]

3.  Secondary:   Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).   [ Time Frame: 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. ]

4.  Secondary:   Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).   [ Time Frame: 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. ]

5.  Secondary:   Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).   [ Time Frame: 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. ]

6.  Secondary:   Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).   [ Time Frame: 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. ]

7.  Secondary:   Part A: Duration of Unconfirmed Objective Response.   [ Time Frame: From first drug administration until end of Part A, up to 929 days. ]

8.  Secondary:   Part B: Duration of Unconfirmed Objective Response.   [ Time Frame: From first drug administration until end of Part B, up to 929 days. ]

9.  Secondary:   Part A: Progression Free Survival.   [ Time Frame: From first drug administration until end of Part A, up to 713 days. ]

10.  Secondary:   Part B: Progression Free Survival.   [ Time Frame: From first drug administration until end of Part B, up to 230 days. ]

11.  Secondary:   Progression Free Survival Over the Whole Sudy.   [ Time Frame: From first drug administration until end of study, up to 700 days. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Boehringer Ingelheim (BI) decided to stop further inclusion of patients and stop further treatment with the combination of Afatinib and Vinorelbine as of 03-May-2013. Recruitment into the trial was stopped by amendment in Jul 2013.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim (BI)
phone: 1800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01325428     History of Changes
Other Study ID Numbers: 1200.89
2010-024454-10 ( EudraCT Number: EudraCT )
First Submitted: March 28, 2011
First Posted: March 29, 2011
Results First Submitted: November 17, 2015
Results First Posted: February 11, 2016
Last Update Posted: July 19, 2016