Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000030572
Ethics application status
Approved
Date submitted
16/01/2006
Date registered
20/01/2006
Date last updated
20/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
An open label phase 2 study of doxorubicin and cyclophosphamide followed by paclitaxel (AC-T) delivered every 14 days with pegfilgrastim and darbepoetin alfa support for the adjuvant treatment of women with breast cancer
Scientific title
An open label phase 2 study of doxorubicin and cyclophosphamide followed by paclitaxel (AC-T) delivered every 14 days with pegfilgrastim and darbepoetin alfa support for the adjuvant treatment of women with breast cancer
Secondary ID [1] 231 0
Amgen: Amgen protocol number 20040137
Universal Trial Number (UTN)
Trial acronym
ACCELERATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early stage breast cancer 993 0
Condition category
Condition code
Cancer 1068 1068 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dose dense doxorubicin and cyclophosphamide followed by paclitaxel will be given to patients every 14 days for a total of 8 cycles. Each cycle will be suported with pegfilgrastim and for patients who have HB <110 g/ml, darbepotin alfa will be administered.
Intervention code [1] 835 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1431 0
Proportion of subjects experiencing a delay in any cycle of chemotherapy at any time over the course of the study.
Timepoint [1] 1431 0
Secondary outcome [1] 2527 0
Proportion of chemotherapy cycles dose delayed at any time over the course of study.
Timepoint [1] 2527 0
Secondary outcome [2] 2528 0
Proportion of subjects experencing any dose reduction at any time over the course of the study.
Timepoint [2] 2528 0
Secondary outcome [3] 2529 0
Proportion of chemotherapy cycles dose reduced at any time over the course of study.
Timepoint [3] 2529 0
Secondary outcome [4] 2530 0
Proportion of chemotherapy cycles dose delayed due to haematological toxicity at any time over the course of study.
Timepoint [4] 2530 0
Secondary outcome [5] 2531 0
Incidence of febrile neutropenia at any time during the study.
Timepoint [5] 2531 0
Secondary outcome [6] 2532 0
Incidence, units and reasons for RBC transfusion at any time during the study.
Timepoint [6] 2532 0
Secondary outcome [7] 2533 0
Incidence of adverse events at any time over the course of the study.
Timepoint [7] 2533 0

Eligibility
Key inclusion criteria
1) Lymph node positive (AJCC stage IIA, IIB or IIIA (T0-3, N1-2, M0) OR 2) High risk lymph node negative, defined as any/all of the following: Hormone receptor negative, <35 years old, T2-3, Histological grade III-Primary surgery consisting of removal of the entire cancer-ECOG 0, 1 or 2-Normal marrow and organ function.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Stage IIIB, IIIC or IV breast cancer- Documented HER2 neu postive disease- Prior malignancy within 5 years except curatively treated basal cell carcinoma, in-situ cervical catrcinoma or a surgically cured malignancy- Previous cytotoxic chemotherapy or therapeutic radiation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1168 0
Commercial sector/Industry
Name [1] 1168 0
Amgen Australia
Country [1] 1168 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Amgen Australia
Address
Country
Australia
Secondary sponsor category [1] 1029 0
Commercial sector/Industry
Name [1] 1029 0
Amgen Australia
Address [1] 1029 0
Country [1] 1029 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2486 0
Royal Melbourne Hosptial
Ethics committee address [1] 2486 0
Ethics committee country [1] 2486 0
Australia
Date submitted for ethics approval [1] 2486 0
Approval date [1] 2486 0
Ethics approval number [1] 2486 0
Ethics committee name [2] 2487 0
Western Hospital
Ethics committee address [2] 2487 0
Ethics committee country [2] 2487 0
Australia
Date submitted for ethics approval [2] 2487 0
Approval date [2] 2487 0
Ethics approval number [2] 2487 0
Ethics committee name [3] 2488 0
Queen Elizabeth Hospital
Ethics committee address [3] 2488 0
Ethics committee country [3] 2488 0
Australia
Date submitted for ethics approval [3] 2488 0
Approval date [3] 2488 0
Ethics approval number [3] 2488 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35431 0
Address 35431 0
Country 35431 0
Phone 35431 0
Fax 35431 0
Email 35431 0
Contact person for public queries
Name 10024 0
Ian Murray
Address 10024 0
Amgen Australia Pty Ltd
Level 7
123 Epping Road
North Ryde NSW 2113
Country 10024 0
Australia
Phone 10024 0
+61 2 98701381
Fax 10024 0
+61 2 98701344
Email 10024 0
imurray@amgen.com
Contact person for scientific queries
Name 952 0
Ian Murray
Address 952 0
Amgen Australia Pty Ltd
Level 7
123 Epping Road
North Ryde NSW 2113
Country 952 0
Australia
Phone 952 0
+61 2 98701381
Fax 952 0
+61 2 98701344
Email 952 0
imurray@amgen.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.