Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000305527
Ethics application status
Approved
Date submitted
7/11/2000
Date registered
7/11/2000
Date last updated
7/11/2000
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical trial of neoadjuvant taxane chemotherapy for women with locally advanced breast cancer
Scientific title
A phase II clinical trial assessing clinical and pathological response rates after the administration of neoadjuvant doxorubicin & docetaxel to women with locally advanced breast cancer (UICC staging T3 or T4, N1 or N2, M0)
Secondary ID [1] 20 0
National Clinical Trials Registry: NCTR340
Universal Trial Number (UTN)
Trial acronym
VCOG BR 1-99
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally advanced breast cancer 20 0
Condition category
Condition code
Cancer 20 20 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Locally advanced breast cancer diagnosis was confirmed by fine needle aspirate or core biopsy as well as multidisciplinary assessment by any two out three disciplines - surgeon, medical oncologist or radiation oncologist prior to study entry. After 6 cycles of chemotherapy, surgical assessment was performed and mastectomy recommended. Following this, radiotherapy and tamoxifen were strongly recommended and constituted part of the study protocol. Chemotherapy was given for six cycles every 21 days - doxorubicin 50 mg/m2 followed one hour later by docetaxel 75 mg/m2 . Steroid administration consisted of six oral doses of dexamethasone 8mg. Chemotherapy was ceased if disease remained static for three cycles, if progression occurred.

Neutropenia was managed by the prophylactic use of G-CSF. Subcutaneous injections commenced 24 – 48 hours after the completion of each cycle of chemotherapy and continued for seven days or until neutrophil recovery (> 1.5 x 109/L).

Quality of life was assessed at baseline, cycles 2 and 4 before chemotherapy was given, and then at months 5, 9, 12, 18 and 24.
Intervention code [1] 1100 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 35 0
Time to clinical response
Timepoint [1] 35 0
Primary outcome [2] 36 0
Pathologic response rate
Timepoint [2] 36 0
Primary outcome [3] 37 0
Time to local and systemic progression
Timepoint [3] 37 0
Secondary outcome [1] 59 0
Survival time
Timepoint [1] 59 0
From first diagnosis.
Secondary outcome [2] 60 0
Quality of life
Timepoint [2] 60 0
Secondary outcome [3] 61 0
Toxicities
Timepoint [3] 61 0

Eligibility
Key inclusion criteria
1. Pre and post menopausal women with histologically proven locally advanced breast cancer as assessed by at least two clinicians ie surgeon &/or medical oncologist &/or radiation oncologist (UICC guidelines disease ranging between T3 and N2 to T4c and N1)2. Diagnosis of invasive adenocarcinoma is confirmed by core biopsy. A fine needle aspirate is acceptable but not encouraged3. Axillary lymph nodes clinically examined and may contain invasive tumour; may be fixed to one another or other structures4. The determination of oestrogen (ER) and progresterone (PgR) receptors is mandatory and results must be known by the end of chemotherapy to determine if hormonal therapy is indicated. ER and/or PgR are considered positive if > or = 1% of cells stain positively regardless of staining intensity, using immunohistochemistry5. All subjects should be evaluated at baseline and negative for distal and regional metastatic disease6. All subjects must be fit for and agree in principle to mastectomy and axillary dissection prior to study entry7. Subjects must be < or = 70 yrs of age8. Adequate renal and liver function and blood counts9.Left ventricular efection fraction (LVEF) must be normal (>50%) and electrocardiography (ECG) must not preclude anthracycline use.10.The subject must be able to give written informed consent according to the rules at each institution. The human rights Declaration of Helsinki must be the basis for the inclusion of patients.
Minimum age
Not stated
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/08/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 27 0
Charities/Societies/Foundations
Name [1] 27 0
The Cancer Council Victoria
Country [1] 27 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Cancer Council Victoria
Address
Country
Australia
Secondary sponsor category [1] 24 0
Charities/Societies/Foundations
Name [1] 24 0
The Cancer Council Victoria
Address [1] 24 0
Country [1] 24 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 262 0
The Alfred
Ethics committee address [1] 262 0
Ethics committee country [1] 262 0
Australia
Date submitted for ethics approval [1] 262 0
Approval date [1] 262 0
27/02/2001
Ethics approval number [1] 262 0
Ethics committee name [2] 263 0
Austin Hospital
Ethics committee address [2] 263 0
Ethics committee country [2] 263 0
Australia
Date submitted for ethics approval [2] 263 0
Approval date [2] 263 0
15/11/2000
Ethics approval number [2] 263 0
Ethics committee name [3] 264 0
Ballarat Oncology Svces
Ethics committee address [3] 264 0
Ethics committee country [3] 264 0
Australia
Date submitted for ethics approval [3] 264 0
Approval date [3] 264 0
28/03/2001
Ethics approval number [3] 264 0
Ethics committee name [4] 265 0
Border Med Oncology
Ethics committee address [4] 265 0
Ethics committee country [4] 265 0
Australia
Date submitted for ethics approval [4] 265 0
Approval date [4] 265 0
27/11/2000
Ethics approval number [4] 265 0
Ethics committee name [5] 266 0
Box Hill Hospital
Ethics committee address [5] 266 0
Ethics committee country [5] 266 0
Australia
Date submitted for ethics approval [5] 266 0
Approval date [5] 266 0
16/11/2000
Ethics approval number [5] 266 0
Ethics committee name [6] 267 0
Flinders Medical Centre
Ethics committee address [6] 267 0
Ethics committee country [6] 267 0
Australia
Date submitted for ethics approval [6] 267 0
Approval date [6] 267 0
14/03/2003
Ethics approval number [6] 267 0
Ethics committee name [7] 268 0
Geelong Hospital
Ethics committee address [7] 268 0
Ethics committee country [7] 268 0
Australia
Date submitted for ethics approval [7] 268 0
Approval date [7] 268 0
19/10/2000
Ethics approval number [7] 268 0
Ethics committee name [8] 269 0
Monash MC
Ethics committee address [8] 269 0
Ethics committee country [8] 269 0
Australia
Date submitted for ethics approval [8] 269 0
Approval date [8] 269 0
19/12/2000
Ethics approval number [8] 269 0
Ethics committee name [9] 270 0
PMCI
Ethics committee address [9] 270 0
Ethics committee country [9] 270 0
Date submitted for ethics approval [9] 270 0
Approval date [9] 270 0
30/05/2001
Ethics approval number [9] 270 0
Ethics committee name [10] 271 0
St Vincent's Hospital
Ethics committee address [10] 271 0
Ethics committee country [10] 271 0
Australia
Date submitted for ethics approval [10] 271 0
Approval date [10] 271 0
22/05/2002
Ethics approval number [10] 271 0

Summary
Brief summary
Preliminary studies indicated that docetaxel and doxorubicin work well in patients with incurable breast cancer. The doses used in this study were based on earlier phase I studies. Phase II studies had been done to assess the effect of the combination of docetaxel and doxorubicin. This combination was found to work well in patients with metastatic or incurable breast cancer. This study will allowed us to use both drugs in a different way - that is, before surgery and in patients with locally advanced breast cancer (where the cancer has not spread anywhere else). By doing the study, we hoped to provide better local treatment and better cure rates. This had not yet been proven in earlier studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35275 0
Address 35275 0
Country 35275 0
Phone 35275 0
Fax 35275 0
Email 35275 0
Contact person for public queries
Name 10289 0
Deb Howell
Address 10289 0
The Cancer Council Victoria
1 Rathdowne Street
Carlton VIC 3053
Country 10289 0
Australia
Phone 10289 0
+61 (0)3 9635 5179
Fax 10289 0
+61 (0)3 9635 5410
Email 10289 0
[email protected]
Contact person for scientific queries
Name 1217 0
Dr Mitchell Chipman
Address 1217 0
214 Burgundy Street
Heidelberg, VIC 3084
Country 1217 0
Australia
Phone 1217 0
+61 (0)3 9457 1029
Fax 1217 0
+61 (0)3 9459 1477
Email 1217 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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