Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000387628
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
14/09/2005
Date last updated
12/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
IBCSG 27-02 / BIG 1-02 / NSABP Protocol B-37 Chemotherapy for Radically Resected Loco-regional relapse
Scientific title
IBCSG 27-02 / BIG 1-02 / NSABP Protocol B-37 Chemotherapy for Radically Resected Loco-regional relapse: A randomised clinical trial of adjuvant chemotherapy for radically resected loco-regional relapse of breast cancer
Secondary ID [1] 158 0
National Clinical Trials Registry: NCTR564
Secondary ID [2] 287855 0
NCT00074152
Universal Trial Number (UTN)
Trial acronym
IBCSG 27-02 / BIG 1-02 / NSABP, NCTR564
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 491 0
Condition category
Condition code
Cancer 571 571 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BCSG 27-02 is being conducted internationally by the International Breast Cancer Study Group (IBCSG). The study is coordinated in Australia and New Zealand by Breast Cancer Trials (formerly the Australia and New Zealand Breast Cancer Trials Group). This trial will evaluate the efficacy of adjuvant chemotherapy after radical treatment of a first loco-regional recurrence of breast cancer. IBCSG 27-02 is an international, multicentre, randomised phase III clinical trial of 977 patients with radically treated isolated local and/or regional recurrence of invasive breast cancer after mastectomy or breast-conserving surgery. Women will be randomised in a 2-arm design to receive one of the following: a. Chemotherapy b. Observation Patients may receive radiation therapy and hormonal treatment if the tumour is hormone receptor positive. The adjuvant chemotherapy and hormonal therapy regimen selected is at the discretion of the treating clinician in accord with protocol guidelines. Hormonal therapy is mandatory for patients with ER and or PgR receptor positive tumours. The type and duration of the hormonal therapy is at the discretion of the treating clinician, and will be based on the patient's menopausal status and any previous hormonal therapy treatment. Standard doses and agents should be used. The adjuvant chemotherapy is preferred to consist of 2 or more drugs for a duration of between 3 and 8 cycles, to commence within 4 weeks of randomisation and within 10 weeks of loco-regional recurrence. Radiotherapy is mandatory for patients who have not received prior adjuvant radiotherapy.
Intervention code [1] 429 0
Treatment: Drugs
Comparator / control treatment
Observation
Control group
Active

Outcomes
Primary outcome [1] 653 0
To determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in women with radically resected loco-regional relapsed breast cancer.
Timepoint [1] 653 0
Two interim analyses are planned prior to reaching four years of median follow-up. The target number of events for the study is 347 so, interim analyses will be planned after 135 events and after 240 events have been observed. The main analysis will be conducted in coded fashion to determine if sufficient evidence exists to modify the protocol on the basis of observed differences in disease-free survival (DFS).
Secondary outcome [1] 1356 0
Overall survival
Timepoint [1] 1356 0
Overall survival will be assessed at the time of two interim analyses planned prior to reaching four years of median follow-up. The target number of events for the study is 347 so, interim analyses will be planned after 135 events and after 240 events have been observed.
Secondary outcome [2] 8545 0
Systemic Relapse - defined as any recurrent or metastatic disease in sites other than the local mastectomy scar/chest wall/skin, the ipsilateral breast in case of breast conservation, or the ipsilateral axilla and internal mammary lymph nodes
Timepoint [2] 8545 0
Systemic Relapse will be assessed at the time of two interim analyses planned prior to reaching four years of median follow-up. The target number of events for the study is 347 so, interim analyses will be planned after 135 events and after 240 events have been observed.
Secondary outcome [3] 8546 0
Systemic disease-free survival - defined as the time from randomisation to systemic relapse, appearance of second (non-breast) primary tumour, or death, whichever occurs first.
Timepoint [3] 8546 0
Systemic disease free survival will be assessed at the time of two interim analyses planned prior to reaching four years of median follow-up. The target number of events for the study is 347 so, interim analyses will be planned after 135 events and after 240 events have been observed.
Secondary outcome [4] 8547 0
Sites of first Recurrence - after randomisation, is defined as the site where evidence of a suspicious lesion is proven to be a definitive recurrence.
Timepoint [4] 8547 0
Sites of first recurrence will be assessed at the time of two interim analyses planned prior to reaching four years of median follow-up. The target number of events for the study is 347 so, interim analyses will be planned after 135 events and after 240 events have been observed.
Secondary outcome [5] 8548 0
Incidence of second (non-breast) malignancies - defined as any positive diagnosis of a second (non-breast) primary tumour other than basal cell or squamous cell carcinoma of the skin, breast carcinoma insitu either ipsilateral or contralateral, or cervical carcinoma insitu.
Timepoint [5] 8548 0
Incidence of second (non-breast) malignancies will be assessed at the time of two interim analyses planned prior to reaching four years of median follow-up. The target number of events for the study is 347 so, interim analyses will be planned after 135 events and after 240 events have been observed.
Secondary outcome [6] 8549 0
Causes of deaths without relapse of breast cancer
Timepoint [6] 8549 0
Causes of deaths without relapse of breast cancer will be assessed at the time of two interim analyses planned prior to reaching four years of median follow-up. The target number of events for the study is 347 so, interim analyses will be planned after 135 events and after 240 events have been observed.
Secondary outcome [7] 8550 0
Quality of Life - Results of a questionnaire completed by each patient, will compare differences in QL between patients randomised to receive adjuvant chemotherapy following resection of an operable local or regional recurrence of breast cancer and patients randomised to the observation arm
Timepoint [7] 8550 0
Quality of Life will be assessed at randomisation and at months 9 and 12 from time of randomisation

Eligibility
Key inclusion criteria
Histologically verified first local and/or regional recurrence of invasive breast cancer following mastectomy or breast conserving treatment; surgical resection with clear, or macroscopically involved margins; planned radiotherapy for patients who had no prior adjuvant radiation treatment or who have macroscopically involved margins; hormone receptor positive tumour; medically suitable for chemotherapy of 3 to 6 months duration, signed informed consent provided and geographically accessible for follow up.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with macroscopically incomplete surgery; evidence of distant metastasis; patients with microscopically involved margins and for whom local radiation therapy is impossible; bilateral invasive breast cancer; patients who have had a prior recurrence in any site (except the first loco-regional recurrence); patients, who, before randomization, have a skeletal pain of unknown cause, elevated alkaline phosphatase; patients with other primary malignant tumors except adequately treated carcinoma in situ of the uterine cervix and non-melanoma skin cancer; other non-malignant systemic diseases that would prevent undergoing any of the treatment options, or prolonged follow-up.

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)
The ANZ BCTG Statistical Centre at the NHMRC Clinical Trials Centre, University of Sydney will provide a central randomisation service by fax for all Australian and New Zealand institutions. At the time of study entry all participants will be allocated to one of two treatment arms via a web-based randomization system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated stratified blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
24/02/2005
Actual
12/04/2006
Date of last participant enrolment
Anticipated
Actual
31/01/2010
Date of last data collection
Anticipated
31/12/2020
Actual
22/08/2016
Sample size
Target
977
Accrual to date
Final
162
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment outside Australia
Country [1] 8695 0
New Zealand
State/province [1] 8695 0

Funding & Sponsors
Funding source category [1] 621 0
Self funded/Unfunded
Name [1] 621 0
Breast Cancer Trials
Country [1] 621 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Breast Cancer Trials
Address
PO Box 283
The Junction NSW 2291
Country
Australia
Secondary sponsor category [1] 506 0
Other Collaborative groups
Name [1] 506 0
International Breast Cancer Study Group
Address [1] 506 0
IBCSG Coordinating Center
Effingerstrasse 40
3008 Bern
SWITZERLAND
Country [1] 506 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1737 0
Box Hill Hospital
Ethics committee address [1] 1737 0
Ethics committee country [1] 1737 0
Australia
Date submitted for ethics approval [1] 1737 0
Approval date [1] 1737 0
Ethics approval number [1] 1737 0
Ethics committee name [2] 1738 0
Flinders Medical Centre
Ethics committee address [2] 1738 0
Ethics committee country [2] 1738 0
Australia
Date submitted for ethics approval [2] 1738 0
Approval date [2] 1738 0
01/01/2005
Ethics approval number [2] 1738 0
Ethics committee name [3] 1739 0
Maroondah Hospital
Ethics committee address [3] 1739 0
Ethics committee country [3] 1739 0
Australia
Date submitted for ethics approval [3] 1739 0
Approval date [3] 1739 0
Ethics approval number [3] 1739 0
Ethics committee name [4] 1740 0
Mater Hospital, Sydney
Ethics committee address [4] 1740 0
Ethics committee country [4] 1740 0
Australia
Date submitted for ethics approval [4] 1740 0
Approval date [4] 1740 0
Ethics approval number [4] 1740 0
Ethics committee name [5] 1741 0
Peter MacCallum Cancer Centre
Ethics committee address [5] 1741 0
Ethics committee country [5] 1741 0
Australia
Date submitted for ethics approval [5] 1741 0
Approval date [5] 1741 0
Ethics approval number [5] 1741 0
Ethics committee name [6] 1742 0
Royal Brisbane and Womens Hospital
Ethics committee address [6] 1742 0
Ethics committee country [6] 1742 0
Australia
Date submitted for ethics approval [6] 1742 0
Approval date [6] 1742 0
Ethics approval number [6] 1742 0
Ethics committee name [7] 1743 0
Royal Prince Alfred Hospital
Ethics committee address [7] 1743 0
Ethics committee country [7] 1743 0
Australia
Date submitted for ethics approval [7] 1743 0
Approval date [7] 1743 0
Ethics approval number [7] 1743 0

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

Contacts
Principal investigator
Name 35795 0
Prof Fran Boyle
Address 35795 0
The Poche Centre
40 Rocklands Road
NORTH SYDNEY NSW 2060
Country 35795 0
Australia
Phone 35795 0
+61 (02) 9957-7744
Fax 35795 0
Email 35795 0
[email protected]
Contact person for public queries
Name 9618 0
Corinna Beckmore
Address 9618 0
BCT
PO Box 283
The Junction NSW 2291
Country 9618 0
Australia
Phone 9618 0
+61 2 4925 5235
Fax 9618 0
+61 2 4925 5235
Email 9618 0
[email protected]
Contact person for scientific queries
Name 546 0
John F Forbes
Address 546 0
BCT
PO Box 283
The Junction NSW 2291
Country 546 0
Australia
Phone 546 0
+61 2 4925 5235
Fax 546 0
+61 2 4925 5235
Email 546 0
[email protected]

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.