Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000032459
Ethics application status
Approved
Date submitted
20/12/2006
Date registered
11/01/2007
Date last updated
10/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
BCIRG 007 / ANZBCTG 0102
A phase III trial to evaluate Taxotere® and Herceptin® Vs Taxotere®, Carboplatin and Herceptin® as First Line Chemotherapy in Metastatic Breast Cancer patients containing the Her2 Gene Amplification.
Scientific title
A phase III trial to evaluate Taxotere® and Herceptin® Vs Taxotere®, Carboplatin and Herceptin® as First Line Chemotherapy in Metastatic Breast Cancer patients containing the Her2 Gene Amplification.
Secondary ID [1] 259632 0
nil
Universal Trial Number (UTN)
No further information will be provided at this stage of the trial. These queries waste valuable ANZ BCTG staff time.
Trial acronym
BCIRG 007 / ANZBCTG 0102
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 1530 0
Condition category
Condition code
Cancer 1626 1626 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: Docetaxel 100mg/m2 i.v, and Herceptin 4mg/kg i.v, on day 1 cycle 1 , then Herceptin 2mg/kg i.v, weekly until completion of chemotherapy. Chemotherapy will consist of 8, 21 day cycles. Hereceptin treatment will continue at 6mg/kg i.v, every 3 weeks until disease progression.
Intervention code [1] 1516 0
Treatment: Drugs
Comparator / control treatment
Arm B: Docetaxel 75mg/m2 i.v, carboplatin 6mg/ml/min i.v, and Herceptin 4mg/kg i.v, day 1 cycle 1, then Herceptin 2mg/kg i.v, weekly until completion of chemotherapy. Chemotherapy will consist of 8, 21 day cycles. Hereceptin treatment will continue at 6mg/kg i.v, every 3 weeks until disease progression.
Control group
Active

Outcomes
Primary outcome [1] 2245 0
To evaluate time to disease progression after treatment with either Herceptin in combination with single agent docetaxel or Herceptin with carboplatin and docetaxel in metastatic breast cancer patients previously untreated with chemotherapy for advanced disease and whose cancer contains the Her2 gene amplification.
Timepoint [1] 2245 0
All patients must be evaluated for 5 years after the last patient has been accrued. Patients will be reviewed by clinician for disease progression every 2 months until disease progression
Secondary outcome [1] 3915 0
To compare response rate, duration of overall response, overall survival.
Timepoint [1] 3915 0
All patients must be evaluated for 5 years after the last patient has been accrued. Patients will be assessed by clinician for the seconday outcomes every 2 months until disease progression, second primary malignancy (except curatively treated non melanoma skin cancer or carcinoma in situ of the cervix), other antitumor therapy administration or death.
Secondary outcome [2] 3916 0
To evaluate and compare the rate of clinical benefit, defined as CR (complete response), PR (partial response), or stable disease > 24 weeks. To compare toxicity between the 2 arms.
Timepoint [2] 3916 0
All patients must be evaluated for 5 years after the last patient has been accrued. Patients will be assessed by clinician for the seconday outcomes every 2 months until disease progression, second primary malignancy (except curatively treated non melanoma skin cancer or carcinoma in situ of the cervix), other antitumor therapy administration or death.
Secondary outcome [3] 3917 0
To evaluate pathologic and molecular markers for predicting efficacy.
Timepoint [3] 3917 0
All patients must be evaluated for 5 years after the last patient has been accrued. Patients will be assessed by clinician for the seconday outcomes every 2 months until disease progression, second primary malignancy (except curatively treated non melanoma skin cancer or carcinoma in situ of the cervix), other antitumor therapy administration or death.
Secondary outcome [4] 3918 0
To correlate baseline peripheral levels of shed Her2 extracellular domain (ECD) with baseline FISH results and to determine whether peripheral levels of shed Her2 ECD constitute a prognostic and/or predictive factor of time to progression and survival.
Timepoint [4] 3918 0
All patients must be evaluated for 5 years after the last patient has been accrued. Patients will be assessed by clinician for the seconday outcomes every 2 months until disease progression, second primary malignancy (except curatively treated non melanoma skin cancer or carcinoma in situ of the cervix), other antitumor therapy administration or death.
Secondary outcome [5] 3919 0
To evaluate genetic and biochemical markers for predicting risk of developing cardiac dysfunction and later cardiac events in this patient population.
Timepoint [5] 3919 0
All patients must be evaluated for 5 years after the last patient has been accrued. Patients will be assessed by clinician for the seconday outcomes every 2 months until disease progression, second primary malignancy (except curatively treated non melanoma skin cancer or carcinoma in situ of the cervix), other antitumor therapy administration or death.

Eligibility
Key inclusion criteria
1. Written informed consent 2. Histologically or cytologically proven breast adenocarcinoma at first diagnosis.3. Metastatic breast cancer.4. Patients must have either measurable or nonmeasurable lesions according to the RECIST criteria.5. Primary tumour or metastatic tumour must show HER2 gene amplification by Fluorescence In-Situ Hybridization (FISH analysis) 6. Age >18 years and age <75 years. The upper age limit is not meant to be exclusionary but rather is based on the lack of safety data for the TCH regimen in women >75 years of age.7. Karnofsky Performance status index > or equal to 60%.8. Previous Therapya. Hormonal therapy- patients may have had previous hormonal therapy provided that the patient has stop the hormonal agent at the time of randomization.b. Chemotherapy- patients may have had adjuvant and/or neoadjuvant chemotherapy.c. Herceptin® - Patients having received a Herceptin®-containing regimen (except Herceptin® and taxane combination) as prior adjuvant and/or neoadjuvant therapy are eligible providing the relapse occurred at least 6 months following discontinuation of Herceptin®. Patients CANNOT have had Herceptin® for locally advanced or metastatic breast cancer.d. Radiotherapy -Previous radiation therapy may have been given providing at least 4 weeks has elapsed from the end of radiotherapy and study registration 9. Patients must have fully recovered from toxic effects of previous antitumor therapy, excluding alopecia.10. Normal cardiac function must be confirmed by LVEF (MUGA scan or echocardiography) and ECG within 1-month prior to registration. Result for the LVEF must be above or equal to the lower limit of normal for the institution.11. Normal Laboratory results: (within 7 days prior to registration)12. Complete radiology and tumour measurement work up within 4 weeks prior to registration.13. Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.14. Patients must be accessible for treatment and follow-up. Patients registered in this trial must be treated and followed in a participating centre.
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior chemotherapy for locally advanced (stage IIIB) disease, local recurrence or metastatic disease.2. Pregnant or lactating patients.3. Prior treatment with Herceptin® for advanced breast cancer.4. Prior Platinum salt containing regimen as adjuvant and/or neoadjuvant therapy for any past or current neoplasm.5. One lytic bone metastasis, blastic bone metastases, mixed bone metastases, lymphangitic carcinomatosis, ascites,pleural/pericardial effusion, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses that are notconfirmed and followed by imaging techniques, cystic lesions and/or irradiated not progressive lesions as onlymanifestation of metastatic disease.6. Prior history or known clinical manifestation of brain or leptomeningeal involvement.7. Non-metastatic disease as evidenced by local recurrent lesion within partially resected breast.8. Concurrent treatment with any other anti-cancer therapy.9. Pre-existing neuropathy-motor or sensory of a severity > or equal to grade 2 by NCI CTC criteria, version 2.0.10. Other serious illness or medical condition:11. Past or current history of neoplasm other than breast carcinoma, except for:a. Curatively treated non-melanoma skin cancer;b. Carcinoma in situ of the cervix;c. Other cancer curatively treated and with no evidence of disease for at least 10 years.12. Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose13. Concomitant therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), given for breast cancer prevention or for osteoporosis. Patients must have discontinued theseagents prior to registration.14. Concomitant treatment with bisphosphonates may be used in patients with tumor lesions other than only bone lesions orfor non-oncologic indications.15. Definite contraindications for the use of corticosteroids.16. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational notmarketed drug within 30 days prior to study entry.17. Known allergy reactions to any of the drugs used in the study.18. Male patients

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)
central randomisation by phone/fax/computer
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
Completed
Date of first participant enrolment
Anticipated
1/12/2001
Actual
1/10/2002
Date of last participant enrolment
Anticipated
Actual
1/03/2004
Date of last data collection
Anticipated
Actual
Sample size
Target
263
Accrual to date
Final
263
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1773 0
Self funded/Unfunded
Name [1] 1773 0
BCIRG (Breast Cancer International Research Group)
Country [1] 1773 0
Canada
Funding source category [2] 1774 0
Commercial sector/Industry
Name [2] 1774 0
Roche pharmaceuticals
Country [2] 1774 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
Roche pharmaceuticals
Address
Konzern-Hauptsitz
Grenzacherstrasse 124
CH-4070 Basel
Country
Switzerland
Secondary sponsor category [1] 1578 0
Other Collaborative groups
Name [1] 1578 0
BCIRG (Breast Cancer International Research Group)
Address [1] 1578 0
9925 109 St NW, Edmonton, AB T5K 2J8
Country [1] 1578 0
Switzerland
Secondary sponsor category [2] 1579 0
Other Collaborative groups
Name [2] 1579 0
Australia and New Zealand Breast Cancer Trials Group
Address [2] 1579 0
PO BOX 155
HRMC NSW 2310
Country [2] 1579 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3317 0
Ashford Cancer Centre
Ethics committee address [1] 3317 0
Ethics committee country [1] 3317 0
Australia
Date submitted for ethics approval [1] 3317 0
Approval date [1] 3317 0
21/03/2002
Ethics approval number [1] 3317 0
Ethics committee name [2] 3318 0
Auckland Hospital
Ethics committee address [2] 3318 0
Ethics committee country [2] 3318 0
New Zealand
Date submitted for ethics approval [2] 3318 0
Approval date [2] 3318 0
15/07/2002
Ethics approval number [2] 3318 0
Ethics committee name [3] 3319 0
Box Hill Hospital
Ethics committee address [3] 3319 0
Ethics committee country [3] 3319 0
Australia
Date submitted for ethics approval [3] 3319 0
Approval date [3] 3319 0
23/05/2002
Ethics approval number [3] 3319 0
Ethics committee name [4] 3320 0
Christchurch Hospital
Ethics committee address [4] 3320 0
Ethics committee country [4] 3320 0
New Zealand
Date submitted for ethics approval [4] 3320 0
Approval date [4] 3320 0
15/07/2002
Ethics approval number [4] 3320 0
Ethics committee name [5] 3321 0
Frankston Hospital
Ethics committee address [5] 3321 0
Ethics committee country [5] 3321 0
Australia
Date submitted for ethics approval [5] 3321 0
Approval date [5] 3321 0
18/04/2002
Ethics approval number [5] 3321 0
Ethics committee name [6] 3322 0
Mater Hospital Sydney
Ethics committee address [6] 3322 0
Ethics committee country [6] 3322 0
Australia
Date submitted for ethics approval [6] 3322 0
Approval date [6] 3322 0
27/08/2002
Ethics approval number [6] 3322 0
Ethics committee name [7] 3323 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [7] 3323 0
Ethics committee country [7] 3323 0
Australia
Date submitted for ethics approval [7] 3323 0
Approval date [7] 3323 0
12/09/2001
Ethics approval number [7] 3323 0
Ethics committee name [8] 3324 0
Royal Adelaide Hospital
Ethics committee address [8] 3324 0
Ethics committee country [8] 3324 0
Australia
Date submitted for ethics approval [8] 3324 0
Approval date [8] 3324 0
14/02/2002
Ethics approval number [8] 3324 0
Ethics committee name [9] 3325 0
Royal Brisbane and Womens Hospital
Ethics committee address [9] 3325 0
Ethics committee country [9] 3325 0
Australia
Date submitted for ethics approval [9] 3325 0
Approval date [9] 3325 0
Ethics approval number [9] 3325 0
Ethics committee name [10] 3326 0
Royal Melbourne Hospital
Ethics committee address [10] 3326 0
Ethics committee country [10] 3326 0
Australia
Date submitted for ethics approval [10] 3326 0
Approval date [10] 3326 0
21/08/2002
Ethics approval number [10] 3326 0
Ethics committee name [11] 3327 0
St Vincents Hospital Melbourne
Ethics committee address [11] 3327 0
Ethics committee country [11] 3327 0
Australia
Date submitted for ethics approval [11] 3327 0
Approval date [11] 3327 0
04/07/2002
Ethics approval number [11] 3327 0
Ethics committee name [12] 3328 0
Western Hospital
Ethics committee address [12] 3328 0
Ethics committee country [12] 3328 0
Australia
Date submitted for ethics approval [12] 3328 0
Approval date [12] 3328 0
21/08/2002
Ethics approval number [12] 3328 0

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

Contacts
Principal investigator
Name 27450 0
Prof John F Forbes
Address 27450 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 27450 0
Australia
Phone 27450 0
+61 2 4985 0113
Fax 27450 0
Email 27450 0
enquiries@anzbctg.org
Contact person for public queries
Name 10705 0
Corinna Beckmore
Address 10705 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10705 0
Australia
Phone 10705 0
+61 2 4925 3068
Fax 10705 0
+61 2 49850141
Email 10705 0
enquiries@anzbctg.org
Contact person for scientific queries
Name 1633 0
John F Forbes
Address 1633 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1633 0
Australia
Phone 1633 0
+61 2 4925 3068
Fax 1633 0
+61 2 49850141
Email 1633 0
enquiries@anzbctg.org

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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