NCT01325428

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2011

Typical duration for phase_2

Geographic Reach
7 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 11, 2016

Completed
Last Updated

July 19, 2016

Status Verified

June 1, 2016

Enrollment Period

3.3 years

First QC Date

March 28, 2011

Results QC Date

November 17, 2015

Last Update Submit

June 17, 2016

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    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 (9)

  • Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).

    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.

  • Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).

    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).

    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 ).

    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.

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

  • +4 more secondary outcomes

Study Arms (1)

Afatinib once daily (OD)

EXPERIMENTAL

Patients receive afatinib monotherapy once daily until progression of their disease

Drug: Afatinib once daily (OD)Drug: Vinorelbine Weekly

Interventions

Afatinib once daily (OD)DRUG

Patient to receive afatinib monotherapy until progression of their disease

Afatinib once daily (OD)
Vinorelbine WeeklyDRUG

Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy

Afatinib once daily (OD)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

1200.89.10001 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1200.89.10005 Boehringer Ingelheim Investigational Site

Durham, North Carolina, United States

Location

1200.89.61002 Boehringer Ingelheim Investigational Site

East Bentleigh, Victoria, Australia

Location

1200.89.61003 Boehringer Ingelheim Investigational Site

Perth, Western Australia, Australia

Location

1200.89.85201 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1200.89.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1200.89.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1200.89.66002 Boehringer Ingelheim Investigational Site

Bangkok, Thailand

Location

1200.89.66004 Boehringer Ingelheim Investigational Site

Bangkok, Thailand

Location

1200.89.66003 Boehringer Ingelheim Investigational Site

Chiang Mai, Thailand

Location

1200.89.66001 Boehringer Ingelheim Investigational Site

Hat-Yai, Songkhla, Thailand

Location

1200.89.21601 Boehringer Ingelheim Investigational Site

Aryanah, Tunisia

Location

1200.89.21602 Boehringer Ingelheim Investigational Site

Sousse, Tunisia

Location

1200.89.44002 Boehringer Ingelheim Investigational Site

Bournemouth, United Kingdom

Location

1200.89.44001 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1200.89.44003 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

Related Publications (1)

  • Goh G, Schmid R, Guiver K, Arpornwirat W, Chitapanarux I, Ganju V, Im SA, Kim SB, Dechaphunkul A, Maneechavakajorn J, Spector N, Yau T, Afrit M, Ahmed SB, Johnston SR, Gibson N, Uttenreuther-Fischer M, Herrero J, Swanton C. Clonal Evolutionary Analysis during HER2 Blockade in HER2-Positive Inflammatory Breast Cancer: A Phase II Open-Label Clinical Trial of Afatinib +/- Vinorelbine. PLoS Med. 2016 Dec 6;13(12):e1002136. doi: 10.1371/journal.pmed.1002136. eCollection 2016 Dec.

    PMID: 27923043DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

Boehringer Ingelheim (BI) decided to stop further inclusion of patients and stop further treatment with the combination of Afatinib and Vinorelbine as of 03-May-2013. Recruitment into the trial was stopped by amendment in Jul 2013.

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim (BI)
clintriage.rdg@boehringer-ingelheim.com
1800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 29, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 19, 2016

Results First Posted

February 11, 2016

Record last verified: 2016-06

Locations

TU(2)GB(3)AU(2)US(2)HK(1)KR(2)TH(4)