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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00463788




Registration number
NCT00463788
Ethics application status
Date submitted
19/04/2007
Date registered
20/04/2007
Date last updated
13/02/2014

Titles & IDs
Public title
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
Scientific title
Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative, PgR-negative, HER2-negative Metastatic Breast Carcinoma ("Basal Like")
Secondary ID [1] 0 0
EMR 200027-051
Universal Trial Number (UTN)
Trial acronym
BALI-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cetuximab, cisplatin
Treatment: Drugs - cisplatin

Experimental: cisplatin and cetuximab -

Active Comparator: cisplatin -


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
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 outcome [1] 0 0
Progression-Free Survival (PFS) Time - 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.
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Overall Survival (OS) Time - 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.
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Time to Response (TTR) - 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.
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Safety- Number of Participants Experiencing Any Adverse Event (AE) - 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.
Timepoint [4] 0 0
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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior platinum agent

- Prior mitomycin

- Known history of brain metastases

- Other protocol-defined exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Campbelltown
Recruitment hospital [2] 0 0
Research Site - Liverpool
Recruitment hospital [3] 0 0
Research Site - Wollongong
Recruitment hospital [4] 0 0
Research Site - Malvern
Recruitment hospital [5] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
- Campbelltown
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
- Wollongong
Recruitment postcode(s) [4] 0 0
- Malvern
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Bludesch-Gais
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussels
Country [5] 0 0
Belgium
State/province [5] 0 0
Edegem
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Belgium
State/province [7] 0 0
Liège
Country [8] 0 0
Belgium
State/province [8] 0 0
Namur
Country [9] 0 0
Belgium
State/province [9] 0 0
Wilrijk
Country [10] 0 0
Germany
State/province [10] 0 0
Frankfurt am Main
Country [11] 0 0
Germany
State/province [11] 0 0
Heidelberg
Country [12] 0 0
Germany
State/province [12] 0 0
Kiel
Country [13] 0 0
Germany
State/province [13] 0 0
Köln
Country [14] 0 0
Germany
State/province [14] 0 0
München
Country [15] 0 0
Germany
State/province [15] 0 0
Rostock
Country [16] 0 0
Ireland
State/province [16] 0 0
Dublin
Country [17] 0 0
Israel
State/province [17] 0 0
Beer Sheba
Country [18] 0 0
Israel
State/province [18] 0 0
Haifa
Country [19] 0 0
Israel
State/province [19] 0 0
Jerusalem
Country [20] 0 0
Israel
State/province [20] 0 0
Kefar Sava
Country [21] 0 0
Israel
State/province [21] 0 0
Petah Tikva
Country [22] 0 0
Israel
State/province [22] 0 0
Rehovot
Country [23] 0 0
Israel
State/province [23] 0 0
Tel Aviv
Country [24] 0 0
Israel
State/province [24] 0 0
Tel Hashomer
Country [25] 0 0
Italy
State/province [25] 0 0
Genova
Country [26] 0 0
Italy
State/province [26] 0 0
Modena
Country [27] 0 0
New Zealand
State/province [27] 0 0
Christchurch
Country [28] 0 0
New Zealand
State/province [28] 0 0
Wellington
Country [29] 0 0
Portugal
State/province [29] 0 0
Coimbra
Country [30] 0 0
Portugal
State/province [30] 0 0
Lisboa
Country [31] 0 0
Portugal
State/province [31] 0 0
Porto
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Murcia
Country [35] 0 0
Spain
State/province [35] 0 0
Palma de Mallorca
Country [36] 0 0
Spain
State/province [36] 0 0
Valencia
Country [37] 0 0
Spain
State/province [37] 0 0
Zaragoza
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Cardiff
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Guildford
Country [40] 0 0
United Kingdom
State/province [40] 0 0
London
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck KGaA, Darmstadt, Germany
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00463788
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
José Baselga, Prof.
Address 0 0
General Hospital, Boston, Massachusetts, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications