ANZCTR - Registration

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]

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

Condition category

Condition code

Cancer

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]

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]

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]

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]

To compare response rate, duration of overall response, overall survival.

Timepoint [1]

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]

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]

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]

To evaluate pathologic and molecular markers for predicting efficacy.

Timepoint [3]

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]

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]

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]

To evaluate genetic and biochemical markers for predicting risk of developing cardiac dysfunction and later cardiac events in this patient population.

Timepoint [5]

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

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]

Self funded/Unfunded

Name [1]

BCIRG (Breast Cancer International Research Group)

Country [1]

Canada

Funding source category [2]

Commercial sector/Industry

Name [2]

Roche pharmaceuticals

Country [2]

Switzerland

Primary sponsor type

Commercial sector/Industry

Name

Roche pharmaceuticals

Country

Switzerland

Secondary sponsor category [1]

Other Collaborative groups

Name [1]

BCIRG (Breast Cancer International Research Group)

Country [1]

Switzerland

Secondary sponsor category [2]

Other Collaborative groups

Name [2]

Australia and New Zealand Breast Cancer Trials Group

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ashford Cancer Centre

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/03/2002

Ethics approval number [1]

Ethics committee name [2]

Auckland Hospital

Ethics committee address [2]

Ethics committee country [2]

New Zealand

Date submitted for ethics approval [2]

Approval date [2]

15/07/2002

Ethics approval number [2]

Ethics committee name [3]

Box Hill Hospital

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

23/05/2002

Ethics approval number [3]

Ethics committee name [4]

Christchurch Hospital

Ethics committee address [4]

Ethics committee country [4]

New Zealand

Date submitted for ethics approval [4]

Approval date [4]

15/07/2002

Ethics approval number [4]

Ethics committee name [5]

Frankston Hospital

Ethics committee address [5]

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

18/04/2002

Ethics approval number [5]

Ethics committee name [6]

Mater Hospital Sydney

Ethics committee address [6]

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

Approval date [6]

27/08/2002

Ethics approval number [6]

Ethics committee name [7]

Newcastle Mater Misericordiae Hospital

Ethics committee address [7]

Ethics committee country [7]

Australia

Date submitted for ethics approval [7]

Approval date [7]

12/09/2001

Ethics approval number [7]

Ethics committee name [8]

Royal Adelaide Hospital

Ethics committee address [8]

Ethics committee country [8]

Australia

Date submitted for ethics approval [8]

Approval date [8]

14/02/2002

Ethics approval number [8]

Ethics committee name [9]

Royal Brisbane and Womens Hospital

Ethics committee address [9]

Ethics committee country [9]

Australia

Date submitted for ethics approval [9]

Approval date [9]

Ethics approval number [9]

Ethics committee name [10]

Royal Melbourne Hospital

Ethics committee address [10]

Ethics committee country [10]

Australia

Date submitted for ethics approval [10]

Approval date [10]

21/08/2002

Ethics approval number [10]

Ethics committee name [11]

St Vincents Hospital Melbourne

Ethics committee address [11]

Ethics committee country [11]

Australia

Date submitted for ethics approval [11]

Approval date [11]

04/07/2002

Ethics approval number [11]

Ethics committee name [12]

Western Hospital

Ethics committee address [12]

Ethics committee country [12]

Australia

Date submitted for ethics approval [12]

Approval date [12]

21/08/2002

Ethics approval number [12]

Summary

Brief summary

Approximately 20-30% of women with advanced breast cancer have a genetic
alteration in the HER2 gene (human epidermal growth factor receptor-2), causing an over-expression of the HER2 protein in the tumour, which is associated with a more
aggressive disease and a worse prognosis. Patients with this type of breast cancer
benefit from treatment with Herceptin when the patient has not previously received
chemotherapy for their advanced disease. This randomised clinical trial evaluates the
use of Herceptin in combination with currently available chemotherapy treatments in providing a better outcome for these patients by delaying progression of the cancer and death with as little toxicity as possible. The trial will compare two treatments: (1)
a combination of the drugs Taxotereâ, platinum salt and Herceptinâ and (2) a standard treatment of Taxotereâ and Herceptinâ in combination without platinum salt.

Trial website

Public notes

Contacts

Principal investigator

Name

Prof John F Forbes

Address

ANZBCTG
PO Box 283
The Junction NSW 2291

Country

Australia

Phone

+61 2 4985 0113

Email

[email protected]

Contact person for public queries

Name

Corinna Beckmore

Address

ANZBCTG
PO Box 283
The Junction NSW 2291

Country

Australia

Phone

+61 2 4925 3068

Email

[email protected]

Contact person for scientific queries

Name

John F Forbes

Address

ANZBCTG
PO Box 283
The Junction NSW 2291

Country

Australia

Phone

+61 2 4925 3068

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically