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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms

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Trial Information

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

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

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Clinical Benefit (CB) assessed by Complete Response (CR), Partial Response (PR) and Stable Disease (SD) for at least 6 months using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

Outcome Time Frame:

Every 8 weeks

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Australia: Dept of Health and Ageing Therapeutic Goods Admin

Study ID:

1200.89

NCT ID:

NCT01325428

Start Date:

August 2011

Completion Date:

June 2014

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Inflammatory Breast Neoplasms

Name

Location

1200.89.10001 Boehringer Ingelheim Investigational SiteLos Angeles, California  
1200.89.10005 Boehringer Ingelheim Investigational SiteDurham, North Carolina  
1200.89.10004 Boehringer Ingelheim Investigational SiteHouston, Texas  
1200.89.10002 Boehringer Ingelheim Investigational SiteHershey, Pennsylvania