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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00321633




Registration number
NCT00321633
Ethics application status
Date submitted
2/05/2006
Date registered
4/05/2006
Date last updated
26/08/2013

Titles & IDs
Public title
Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer
Scientific title
A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]
Secondary ID [1] 0 0
CRUK-BRCA-TRIAL
Secondary ID [2] 0 0
CDR0000467994
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
brca1 Mutation Carrier 0 0
brca2 Mutation Carrier 0 0
Breast Cancer 0 0
Hereditary Breast/Ovarian Cancer (brca1, brca2) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - carboplatin
Treatment: Drugs - docetaxel

Treatment: Drugs: carboplatin


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

Outcomes
Primary outcome [1] 0 0
Response and toxicity
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Time to progression
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed breast cancer

- BRCA1 or BRCA2 mutation carrier

- Metastatic disease

- Measurable disease, defined as = 1 unidimensionally measurable lesion = 20 mm by
conventional techniques or = 10 mm by spiral CT scan

- Stable, treated brain metastases allowed provided other sites of measurable disease
are present

- Patients with bone metastases who are currently receiving bisphosphonates for
palliation are eligible provided other sites of measurable disease are present

- Patients who have not received anthracycline-based chemotherapy in the adjuvant
setting may receive a non-taxane, anthracycline regimen as the first-line metastatic
treatment and enter the trial at confirmed progression (second-line)

- No bone-limited disease

- No disease suitable for endocrine therapy alone

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- Sex: female

- WHO performance status 0-2

- Life expectancy = 3 months

- AST and/or ALT = 5 times upper limit of normal (ULN) (= 3 if alkaline phosphatase > 5
times ULN)

- Glomerular filtration rate = 30 mL/min

- Normal urea and creatinine

- Normal hematological and biochemical studies

- Normal bilirubin

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment

- Negative pregnancy test

- No known allergy to platinum compounds or mannitol

- No known sensitivity to taxanes

- No other malignancy within the past 10 years except adequately treated in situ
carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin

- No sensory or motor neuropathy > grade 1

- No other serious uncontrolled medical conditions or concurrent medical illness that
would preclude study compliance

- No contraindication to chemotherapy

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 12 months since prior taxane therapy

- No prior chemotherapy with a platinum drug, unless treatment was for a non-breast
cancer-related disease more than 10 years ago
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

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
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
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
148
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Israel
State/province [1] 0 0
Beer-Sheva
Country [2] 0 0
Israel
State/province [2] 0 0
Naharia
Country [3] 0 0
Israel
State/province [3] 0 0
Tel Hashomer
Country [4] 0 0
Portugal
State/province [4] 0 0
Lisbon
Country [5] 0 0
Spain
State/province [5] 0 0
Barcelona
Country [6] 0 0
Sweden
State/province [6] 0 0
Lund
Country [7] 0 0
United Kingdom
State/province [7] 0 0
England
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Scotland
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Other
Name
University College London Hospitals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. It is not yet known whether carboplatin is more effective than docetaxel in
treating patients with metastatic genetic breast cancer.

PURPOSE: This randomized phase II trial is studying carboplatin to see how well it works
compared to docetaxel in treating women with metastatic genetic breast cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00321633
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Tutt, MD, PhD, FRCR, MBBS, MRCP
Address 0 0
Guy's Hospital
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00321633