Afatinib (BIBW2992) in HER2-overexpressing Inflammatory Breast Cancer
This study has been completed.
Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01325428
First received: March 28, 2011
Last updated: December 1, 2014
Last verified: November 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: Afatinib once daily (OD) Drug: Vinorelbine Weekly |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- 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) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of participants with changes in vital signs and safety laboratory parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Objective Response (OR) assessed by RECIST 1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Duration of objective response, defined as the time from first objective response to the time of progression or death. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Safety assessed by the intensity and incidence of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 26 |
| Study Start Date: | August 2011 |
| Study Completion Date: | November 2014 |
| Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Afatinib once daily (OD)
Patients receive afatinib monotherapy once daily until progression of their disease
|
Drug: Afatinib once daily (OD)
Patient to receive afatinib monotherapy until progression of their disease
Drug: Vinorelbine Weekly
Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
- Locally advanced or metastatic disease
- Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
- For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
- Investigator-confirmed diagnosis of Inflammatory Breast Cancer
- Must have biopsiable disease
Exclusion criteria:
- Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)
- Must not have received prior vinorelbine treatment
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325428
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325428
Locations
| United States, California | |
| 1200.89.10001 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| United States, North Carolina | |
| 1200.89.10005 Boehringer Ingelheim Investigational Site | |
| Durham, North Carolina, United States | |
| Australia, Victoria | |
| 1200.89.61002 Boehringer Ingelheim Investigational Site | |
| East Bentleigh, Victoria, Australia | |
| Australia, Western Australia | |
| 1200.89.61003 Boehringer Ingelheim Investigational Site | |
| Perth, Western Australia, Australia | |
| Hong Kong | |
| 1200.89.85201 Boehringer Ingelheim Investigational Site | |
| Hong Kong, Hong Kong | |
| Korea, Republic of | |
| 1200.89.82001 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| 1200.89.82002 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| Thailand | |
| 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 | |
| Chiangmai, Thailand | |
| 1200.89.66001 Boehringer Ingelheim Investigational Site | |
| Hat-Yai, Songkhla, Thailand | |
| Tunisia | |
| 1200.89.21601 Boehringer Ingelheim Investigational Site | |
| Ariana, Tunisia | |
| 1200.89.21602 Boehringer Ingelheim Investigational Site | |
| Sousse, Tunisia | |
| United Kingdom | |
| 1200.89.44002 Boehringer Ingelheim Investigational Site | |
| Bournemouth, United Kingdom | |
| 1200.89.44001 Boehringer Ingelheim Investigational Site | |
| London, United Kingdom | |
| 1200.89.44003 Boehringer Ingelheim Investigational Site | |
| London, United Kingdom | |
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01325428 History of Changes |
| Other Study ID Numbers: | 1200.89, 2010-024454-10 |
| Study First Received: | March 28, 2011 |
| Last Updated: | December 1, 2014 |
| Health Authority: | Australia: Dept of Health and Ageing Therapeutic Goods Admin Hong Kong: Department of Health South Korea: Ministry of Food and Drug Safety (MFDS) Thailand: Food and Drug Administration Tunisia: Ministry of Public Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Inflammatory Breast Neoplasms Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases |
Vinorelbine Antineoplastic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015