Clinical trial NCT00463788: Cetuximab and Cisplatin in the Treatment of "Triple Negative" (Estrogen Receptor [ER] Negative, Progesterone Receptor [PgR] Negative, and Human Epidermal Growth Factor Receptor 2 [HER2] Negative) Metastatic Breast Cancer
Official title: Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative, PgR-negative, HER2-negative Metastatic Breast Carcinoma ("Basal Like")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasm
Keywords: cancer
breast
metastatic
triple negative
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2007-04-20
Enrollment: 181
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer.

The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival (OS), Time to Response (TTR) and Safety.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of metastatic breast cancer (Stage IV)
* Estrogen Receptor \[ER\] negative, PgR negative and HER2 less than 3+ expression by immunohistochemistry (IHC)
* No more than 1 prior chemotherapy received for treating this metastatic breast cancer
* No more than 1 prior anthracycline and/or taxane regimen (either adjuvant or metastatic setting)
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Prior platinum agent
* Prior mitomycin
* Known history of brain metastases
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Best Overall Response (BOR)
timeFrame: Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009
Secondary outcomes:
measure: Progression-Free Survival (PFS) Time
timeFrame: Time from randomization to disease progression, death or last tumour assessment, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009
measure: Overall Survival (OS) Time
timeFrame: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 20 June 2007, until cut-off date, 05 April 2010
measure: Time to Response (TTR)
timeFrame: Time from the first dose of study treatment (cetuximab or cisplatin) to first assessment of CR or PR, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009
measure: Safety- Number of Participants Experiencing Any Adverse Event (AE)
timeFrame: Time from first dose up to 30 days after last dose of study treatment, reported between day of first dose of study treatment, 20 June 2007, until cut-off date 05 April 2010
Other outcomes:
Locations:
city: Campbelltown
country: Australia
facility: Research Site
state: New South Wales
city: Liverpool
country: Australia
facility: Research Site
state: New South Wales
city: Wollongong
country: Australia
facility: Research Site
state: New South Wales
city: Malvern
country: Australia
facility: Research Site
state: Victoria
city: Perth
country: Australia
facility: Research Site
state: Western Australia
city: Bludesch-Gais
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Beer Sheba
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Kefar Sava
country: Israel
facility: Research Site
city: Petah Tikva
country: Israel
facility: Research Site
city: Rehovot
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Tel Hashomer
country: Israel
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
city: Wellington
country: New Zealand
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Guildford
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: General Hospital, Boston, Massachusetts, USA
name: José Baselga, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shamseddine AI, Farhat FS. Platinum-based compounds for the treatment of metastatic breast cancer. Chemotherapy. 2011;57(6):468-87. doi: 10.1159/000334093. Epub 2012 Jan 10.