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

Boehringer Ingelheim26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Neoplasms

Interventions

Afatinib once daily (OD)DRUG

Patient to receive afatinib monotherapy until progression of their disease

Vinorelbine WeeklyDRUG

Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

1200.89.10001 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1200.89.10005 Boehringer Ingelheim Investigational Site

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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).

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.

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).

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.

Secondary Outcomes

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.

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.

Data from ClinicalTrials.gov

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1200.89.61002 Boehringer Ingelheim Investigational Site

East Bentleigh, Victoria, Australia

1200.89.61003 Boehringer Ingelheim Investigational Site

Perth, Western Australia, Australia

1200.89.85201 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

1200.89.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

1200.89.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

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

Chiang Mai, Thailand

...and 6 more locations

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.

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.

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.

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.

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.

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.

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)).

Time frame: From first drug administration until end of Part A, up to 929 days.

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).

Time frame: From first drug administration until end of Part B, up to 929 days.

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.

Time frame: From first drug administration until end of Part A, up to 713 days.

Part B: Progression Free Survival.

Time frame: From first drug administration until end of Part B, up to 230 days.

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.

Time frame: From first drug administration until end of study, up to 700 days.