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)
January 20, 2014 updated by: Merck KGaA, Darmstadt, Germany
Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative, PgR-negative, HER2-negative Metastatic Breast Carcinoma ("Basal Like")
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
181
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Campbelltown, New South Wales, Australia
- Research Site
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Liverpool, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Victoria
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Malvern, Victoria, Australia
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Western 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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Wien, Austria
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Brussels, Belgium
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Edegem, Belgium
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Gent, Belgium
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Liège, Belgium
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Namur, Belgium
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Wilrijk, Belgium
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Frankfurt am Main, Germany
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Heidelberg, Germany
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Kiel, Germany
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Köln, Germany
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München, Germany
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Rostock, Germany
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Dublin, Ireland
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Beer Sheba, 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 Hashomer, 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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Lisboa, 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
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Manchester, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: cisplatin and cetuximab
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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. |
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Active Comparator: cisplatin
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Best Overall Response (BOR)
Time Frame: 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
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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).
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression-Free Survival (PFS) Time
Time Frame: 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
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The PFS was defined as the duration from randomization until radiological progression according to investigator (based on RECIST) or death due to any cause.
Only deaths within 85 days of last tumor assessment were considered.
Participants without event were censored on the date of last tumor assessment.
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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
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Overall Survival (OS) Time
Time Frame: 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
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The OS time was defined as the time from randomization to death.
Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier.
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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
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Time to Response (TTR)
Time Frame: 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
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The TTR was determined for participants whose confirmed BOR (based on RECIST) was either a CR or a PR .
It was defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR.
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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
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Safety- Number of Participants Experiencing Any Adverse Event (AE)
Time Frame: 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
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Number of participants experiencing any AE.
AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications.
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: José Baselga, Prof., General Hospital, Boston, Massachusetts, USA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
April 19, 2007
First Submitted That Met QC Criteria
April 19, 2007
First Posted (Estimate)
April 20, 2007
Study Record Updates
Last Update Posted (Estimate)
February 13, 2014
Last Update Submitted That Met QC Criteria
January 20, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMR 200027-051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.