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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00463788
Recruitment Status : Completed
First Posted : April 20, 2007
Results First Posted : October 10, 2012
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

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.


Condition or disease Intervention/treatment Phase
Breast Neoplasm Drug: cetuximab, cisplatin Drug: cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: cisplatin and cetuximab Drug: cetuximab, cisplatin

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.


Active Comparator: cisplatin Drug: cisplatin

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.





Primary Outcome Measures :
  1. 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 ]
    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).


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463788


Locations
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Australia, New South Wales
Research Site
Campbelltown, New South Wales, Australia
Research Site
Liverpool, New South Wales, Australia
Research Site
Wollongong, New South Wales, Australia
Australia, Victoria
Research Site
Malvern, Victoria, Australia
Australia, Western Australia
Research Site
Perth, Western Australia, Australia
Austria
Research Site
Bludesch-Gais, Austria
Research Site
Salzburg, Austria
Research Site
Wien, Austria
Belgium
Research Site
Brussels, Belgium
Research Site
Edegem, Belgium
Research Site
Gent, Belgium
Research Site
Liège, Belgium
Research Site
Namur, Belgium
Research Site
Wilrijk, Belgium
Germany
Research Site
Frankfurt am Main, Germany
Research Site
Heidelberg, Germany
Research Site
Kiel, Germany
Research Site
Köln, Germany
Research Site
München, Germany
Research Site
Rostock, Germany
Ireland
Research Site
Dublin, Ireland
Israel
Research Site
Beer Sheba, Israel
Research Site
Haifa, Israel
Research Site
Jerusalem, Israel
Research Site
Kefar Sava, Israel
Research Site
Petah Tikva, Israel
Research Site
Rehovot, Israel
Research Site
Tel Aviv, Israel
Research Site
Tel Hashomer, Israel
Italy
Research Site
Genova, Italy
Research Site
Modena, Italy
New Zealand
Research Site
Christchurch, New Zealand
Research Site
Wellington, New Zealand
Portugal
Research Site
Coimbra, Portugal
Research Site
Lisboa, Portugal
Research Site
Porto, Portugal
Spain
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Murcia, Spain
Research Site
Palma de Mallorca, Spain
Research Site
Valencia, Spain
Research Site
Zaragoza, Spain
United Kingdom
Research Site
Cardiff, United Kingdom
Research Site
Guildford, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Investigators
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Principal Investigator: José Baselga, Prof. General Hospital, Boston, Massachusetts, USA

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00463788    
Other Study ID Numbers: EMR 200027-051
First Posted: April 20, 2007    Key Record Dates
Results First Posted: October 10, 2012
Last Update Posted: February 13, 2014
Last Verified: January 2014
Keywords provided by Merck KGaA, Darmstadt, Germany:
cancer
breast
metastatic
triple negative
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cisplatin
Cetuximab
Antineoplastic Agents
Antineoplastic Agents, Immunological