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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Neoplasms | Drug: Afatinib once daily (OD) Drug: Vinorelbine Weekly | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
---|---|
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
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- 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. ]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).
- 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. ]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).
- 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. ]Objective response was defined on a patient level as a best response of CR or PR.
- 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. ]Objective response was defined on a patient level as a best response of CR or PR.
- 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. ]Objective response was defined on a patient level as a best response of CR or PR.
- 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. ]Objective response was defined on a patient level as a best response of CR or PR.
- Part A: Duration of Unconfirmed Objective Response. [ Time Frame: From first drug administration until end of Part A, up to 929 days. ]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)).
- Part B: Duration of Unconfirmed Objective Response. [ Time Frame: From first drug administration until end of Part B, up to 929 days. ]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).
- Part A: Progression Free Survival. [ Time Frame: From first drug administration until end of Part A, up to 713 days. ]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.
- Part B: Progression Free Survival. [ Time Frame: From first drug administration until end of Part B, up to 230 days. ]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 B.
- Progression Free Survival Over the Whole Sudy. [ Time Frame: From first drug administration until end of study, up to 700 days. ]PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325428
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 |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
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 Posted: | March 29, 2011 Key Record Dates |
Results First Posted: | February 11, 2016 |
Last Update Posted: | July 19, 2016 |
Last Verified: | June 2016 |
Additional relevant MeSH terms:
Breast Neoplasms Inflammatory Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Vinorelbine |
Vinblastine Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |