Clinical trial NCT01325428: Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
Official title: An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
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).
timeFrame: 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.
measure: 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).
timeFrame: 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:
measure: Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
timeFrame: 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.
measure: Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
timeFrame: 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.
measure: Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
timeFrame: 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.
measure: Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).
timeFrame: 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.
measure: Part A: Duration of Unconfirmed Objective Response.
timeFrame: From first drug administration until end of Part A, up to 929 days.
measure: Part B: Duration of Unconfirmed Objective Response.
timeFrame: From first drug administration until end of Part B, up to 929 days.
measure: Part A: Progression Free Survival.
timeFrame: From first drug administration until end of Part A, up to 713 days.
measure: Part B: Progression Free Survival.
timeFrame: From first drug administration until end of Part B, up to 230 days.
measure: Progression Free Survival Over the Whole Sudy.
timeFrame: From first drug administration until end of study, up to 700 days.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: 1200.89.10001 Boehringer Ingelheim Investigational Site
state: California
city: Durham
country: United States
facility: 1200.89.10005 Boehringer Ingelheim Investigational Site
state: North Carolina
city: East Bentleigh
country: Australia
facility: 1200.89.61002 Boehringer Ingelheim Investigational Site
state: Victoria
city: Perth
country: Australia
facility: 1200.89.61003 Boehringer Ingelheim Investigational Site
state: Western Australia
city: Hong Kong
country: Hong Kong
facility: 1200.89.85201 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1200.89.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1200.89.82002 Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: 1200.89.66002 Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: 1200.89.66004 Boehringer Ingelheim Investigational Site
city: Chiangmai
country: Thailand
facility: 1200.89.66003 Boehringer Ingelheim Investigational Site
city: Hat-Yai, Songkhla
country: Thailand
facility: 1200.89.66001 Boehringer Ingelheim Investigational Site
city: Ariana
country: Tunisia
facility: 1200.89.21601 Boehringer Ingelheim Investigational Site
city: Sousse
country: Tunisia
facility: 1200.89.21602 Boehringer Ingelheim Investigational Site
city: Bournemouth
country: United Kingdom
facility: 1200.89.44002 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1200.89.44001 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1200.89.44003 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.