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
BALI-1
Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative, PgR-negative, HER2-negative Metastatic Breast Carcinoma ("Basal Like")
1 other identifier
interventional
181
10 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2007
Typical duration for phase_2
43 active sites
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
April 19, 2007
CompletedFirst Posted
Study publicly available on registry
April 20, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
October 10, 2012
CompletedFebruary 13, 2014
January 1, 2014
2.1 years
April 19, 2007
June 5, 2012
January 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Overall Response (BOR)
Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
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 (4)
Progression-Free Survival (PFS) Time
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
Overall Survival (OS) Time
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
Time to Response (TTR)
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
Safety- Number of Participants Experiencing Any Adverse Event (AE)
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
Study Arms (2)
cisplatin and cetuximab
EXPERIMENTALcisplatin
ACTIVE COMPARATORInterventions
Subjects will receive an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) followed by weekly doses of 250 mg/m\^2. All doses will be given by intravenous (IV) infusion. Subjects will receive cisplatin (75 mg/m\^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles. Administration of the Investigational Medicinal Product (IMP) will be stopped upon the first occurrence of disease progression, unacceptable toxicity or withdrawal of consent.
Subjects will receive cisplatin (75 mg/m\^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles. Subjects have the option of receiving cetuximab plus cisplatin at progression within the first 6 cycles, or cetuximab alone at progression after the 6 cycles. Administration of the IMP will be stopped upon the first occurrence of disease progression (except in cisplatin arm where switch to cetuximab plus cisplatin, or cetuximab alone is possible), unacceptable toxicity or withdrawal of consent.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Prior platinum agent
- Prior mitomycin
- Known history of brain metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Research Site
Campbelltown, New South Wales, Australia
Research Site
Liverpool, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Malvern, Victoria, Australia
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Perth, Western Australia, Australia
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Bludesch-Gais, Austria
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Salzburg, Austria
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Vienna, Austria
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Brussels, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Liège, Belgium
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Namur, Belgium
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Wilrijk, Belgium
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Cologne, Germany
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Frankfurt am Main, Germany
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Heidelberg, Germany
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Kiel, Germany
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München, Germany
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Rostock, Germany
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Dublin, Ireland
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Beersheba, Israel
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Haifa, Israel
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Jerusalem, Israel
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Kefar Sava, Israel
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Petah Tikva, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Genova, Italy
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Modena, Italy
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Christchurch, New Zealand
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Wellington, New Zealand
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Barcelona, Spain
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Madrid, Spain
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Murcia, Spain
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Palma de Mallorca, Spain
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Valencia, Spain
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Zaragoza, Spain
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Cardiff, United Kingdom
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Guildford, United Kingdom
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London, United Kingdom
Research Site
Manchester, United Kingdom
Related Publications (1)
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.
PMID: 22248721DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Participants were randomized to 2 groups in a 2:1 ratio.
Results Point of Contact
- Title
- Merck KGaA Communication Center
- Organization
- Merck KGaA
Study Officials
- PRINCIPAL INVESTIGATOR
José Baselga, Prof.
General Hospital, Boston, Massachusetts, USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2007
First Posted
April 20, 2007
Study Start
June 1, 2007
Primary Completion
July 1, 2009
Study Completion
February 1, 2011
Last Updated
February 13, 2014
Results First Posted
October 10, 2012
Record last verified: 2014-01