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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Boehringer Ingelheim
Study ID
NCT01325428
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 31, 2011
Status verified
Jun 2016
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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. ]

Locations (2)

FacilityCityStateZIPSite coordinators
1200.89.10001 Boehringer Ingelheim Investigational SiteLos AngelesCalifornia--
1200.89.10005 Boehringer Ingelheim Investigational SiteDurhamNorth Carolina--

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
1200.89.10001 Boehringer Ingelheim Investigational Site· Los Angeles, CA1200.89.10005 Boehringer Ingelheim Investigational Site· Durham, NC

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