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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
Gender
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
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)

Funding & Sponsors
Funding source category [1] 1168 0
Commercial sector/Industry
Name [1] 1168 0
Amgen Australia
Address [1] 1168 0
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
This is a dose dense breast cancer study in teh adjuvant setting using growth factor support
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
Summary results
No Results