The SBG 2004-1/ABCSG 25/GBG53 study (the Panther study)
| ISRCTN | ISRCTN39017665 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39017665 |
| EudraCT/CTIS number | 2007-002061-12 |
| ClinicalTrials.gov number | NCT00798070 |
| Secondary identifying numbers | SBG 2004-1/ABCSG 25/GBG53 |
- Submission date
- 19/06/2007
- Registration date
- 14/08/2007
- Last edited
- 02/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jonas Bergh
Scientific
Scientific
Department of Oncology
Karolinska University Hospital
Stockholm
SE-171 76
Sweden
Study information
| Study design | Phase III open prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomised phase III study comparing biweekly and tailored epirubicin plus cyclophosphamide followed by biweekly tailored docetaxel (A-arm) versus three weekly epirubicin plus cyclophosphamide, 5-fluorouracil followed by docetaxel (B-arm) in lymph node positive breast cancer patients - a continuation of the feasibility part of the SBG 2004-1 study |
| Study acronym | The Panther Study |
| Study objectives | The aim of the study is to compare breast cancer recurrence-free survival (BCRFS; local, regional, distant breast cancer relapse or death due to breast cancer) in the tailored therapy arm compared with the fixed dose arm. |
| Ethics approval(s) | Regional Ethical Board in Stockholm (Regionala etikprövningsnämnden i Stockholm), 15/01/2007, ref: 04-647/1 |
| Health condition(s) or problem(s) studied | Lymph node positive breast cancer patients |
| Intervention | Tailored therapy arm: Tailored epirubicin (38 - 120 mg/m^2) and cyclophosphamide (450 - 1200 mg/m^2) will be given intravenously for four courses with granulocyte colony stimulating factor (G-CSF) support. Courses should be given with a biweekly interval followed by four courses docetaxel 75 - 100 mg/m^2 with G-CSF support. The first course will start at EC Step 1, epirubicin 90 mg/m^2 and cyclophosphamide 600 mg/m^2. This is followed by four courses docetaxel 75 - 100 mg/m^2 biweekly with G-CSF support. Starting dose of docetaxel Step 0 is 75 mg/m^2. Fixed dose arm: Three courses of 5-fluorouracil (500 mg/m^2), epirubicin (100 mg/m^2) and cyclophosphamide 500 mg/m^2, given with a 3-week interval, will be followed by three courses of docetaxel 100 mg/m^2 given with a 3-week interval. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Epirubicin, cyclophosphamide, docetaxel, 5-fluorouracil |
| Primary outcome measure | Breast cancer relapse-free survival (local, regional or systemic relapse or death due to breast cancer), assessed during follow-up at 4, 8, 12, 16, 20 months and 2 years and then every 6 months until 5 years. From this point, assessment will be carried out annually until 10 years. |
| Secondary outcome measures | The following three outcomes will be assessed during follow-up at 4, 8, 12, 16, 20 months and 2 years and then every 6 months until 5 years. From this point, assessment will be carried out annually until 10 years: 1. Distant disease-free survival (DDFS) 2. Event-free survival 3. Overall survival 4. Health-related quality of life, assessed at baseline, 6 and 15 weeks during treatment and then at 4, 8 and 12 months during follow up 5. Outcome in relation to tumour biological factors and polymorphism patterns |
| Overall study start date | 01/02/2007 |
| Completion date | 01/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 2000 |
| Key inclusion criteria | Current inclusion criteria as of 24/01/2011: 1. Histologically proven invasive primary breast cancer, with at least 5 (recommended 10) removed axillary lymph nodes. Interval between definitive surgery that includes axillary lymph node dissection and registration must be less than 60 days. Paraffin block from the primary tumour must be retained (not mandatory for Austrian sites). Frozen tumour tissue is strongly recommended to be stored. 2. Receptor-negative or -positive tumours with 1 or more positive axillary lymph nodes (more than 0.2 mm) OR axillary node negative breast cancers if the primary tumour is larger than 20 mm and receptor negative (Er and Pgr with no receptor content) and being Elston grade III. In Germany high-risk node-negative breast cancer patients are not eligible until labelling for docetaxel includes node-negative disease. 3. Macroscopically and microscopically radical surgery, free margins (no cancer cells at borders of resection) 4. No proven distant metastases: negative pulmonary X-ray, bone scintigram (when clinical signs of skeletal metastases or elevated alkaline phosphatase [ALP] is observed) supplemented with normal conventional X-ray of hot spots, normal liver function test and haematological function tests. Abnormal values: computed tomography (CT) or ultrasound of the liver (patient can be included if no metastases are demonstrated). 5. Female aged 18 - 65 years 6. Ambulant patients (Eastern Cooperative Oncology Group [ECOG] 1 or less) 7. No major cardiovascular morbidity: New York Heart Association (NYHA) grade I or II 8. Written informed consent according to the local ethics committee requirements 9. Patients of childbearing potential should have a negative pregnancy test within seven days of registration (in Austria, pregnancy tests have to be repeated monthly during the treatment phase) Previous inclusion criteria: 1. Histologically proven invasive primary breast cancer, with at least 5 (recommended 10) removed axillary lymph nodes. Interval between definitive surgery that includes axillary lymph node dissection and registration must be less than 60 days. Paraffin block from the primary tumour must be retained (not mandatory for Austrian sites). Frozen tumour tissue is strongly recommended to be stored. 2. Receptor-negative or -positive tumours with 1 or more positive axillary lymph nodes (greater than 0.2 mm) 3. Macroscopically and microscopically radical surgery, free margins (no cancer cells at borders of resection) 4. No proven distant metastases: negative pulmonary X-ray, bone scintigram (when clinical signs of skeletal metastases or elevated alkaline phosphatase [ALP] is observed) supplemented with normal conventional X-ray of hot spots, normal liver function test and haematological function tests. Abnormal values: computed tomography (CT) or ultrasound of the liver (patient can be included if no metastases are demonstrated). 5. Female age 18 - 65 years 6. Ambulant patients (Eastern Cooperative Oncology Group [ECOG] 1 or less) 7. No major cardiovascular morbidity: New York Heart Association (NYHA) grade I or II 8. Written informed consent according to the local ethics committee requirements 9. Patients of childbearing potential should have a negative pregnancy test within seven days of registration (in Austria, pregnancy tests have to be repeated monthly during the treatment phase) |
| Key exclusion criteria | Current exclusion criteria as of 24/01/2011: 1. Previous neo-adjuvant treatment 2. Non-radical surgery (histopathological positive margins) 3. A primary breast cancer patient being 35 years or younger considered suitable for adjuvant chemotherapy (may be receptor negative or positive, HER-2/neu negative or positive, with or without axillary lymph node metastases) 4. Proven distant metastases 5. Pregnancy or lactation 6. Other serious medical condition 7. Previous or concurrent malignancies at other sites, except basal cell carcinoma and/or squamous cell carcinoma in situ of the skin or cervix. Patients with previous breast cancer (invasive and/or ductal carcinoma in situ) in the other breast without loco-regional (large lung volumes) radiotherapy, without objective findings for relapse, with greater than 5 years since diagnosis can be included. 8. Abnormal laboratory values precluding the possibility to safely deliver the cytotoxic agents used in the study 9. Hypersensitivity to drugs formulated in polysorbate 80 10. Peripheral neuropathy grade greater than or equal to 2 Previous exclusion criteria: 1. Previous neo-adjuvant treatment 2. Non-radical surgery (histopathological positive margins) 3. Proven distant metastases 4. Pregnancy or lactation 5. Other serious medical condition 6. Previous or concurrent malignancies at other sites, except basal cell carcinoma and/or squamous cell carcinoma in situ of the skin or cervix. Patients with previous breast cancer (invasive and/or ductal carcinoma in situ) in the other breast without loco-regional (large lung volumes) radiotherapy, without objective findings for relapse, with greater than 5 years since diagnosis can be included. 7. Abnormal laboratory values precluding the possibility to safely deliver the cytotoxic agents used in the study 8. Hypersensitivity to drugs formulated in polysorbate 80 9. Peripheral neuropathy grade greater than or equal to 2 |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/08/2011 |
Locations
Countries of recruitment
- Austria
- Germany
- Sweden
Study participating centre
Karolinska University Hospital
Stockholm
SE-171 76
Sweden
SE-171 76
Sweden
Sponsor information
Karolinska University Hospital
University/education
University/education
c/o Prof Jonas Bergh
Radiumhemmet
Department of Oncology
Karolinska University Hospital
Stockholm
SE-171 76
Sweden
| Phone | +46 (0)8 51770000 |
|---|---|
| jonas.bergh@ki.se | |
| Website | http://www.karolinska.se/en |
"ROR" |
https://ror.org/00m8d6786 |
Paracelsus University
University/education
University/education
c/o Richard Greil, MD, Professor
Austrian Breast & Colorectal Cancer Study Group (ABCSG)
Department of Internal Medicine III
Salzburg
A-5020
Austria
Städt. Kliniken Frankfurt-Höchst
Hospital/treatment centre
Hospital/treatment centre
c/o Volker Möbus, MD, Professor
German Breast Group (GBG)
Frauenklinik
Gotenstrasse 6-8
Frankfurt/Höchst
D-65929
Germany
Funders
Funder type
Industry
Swedish Cancer Society (Sweden)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Cancer Society
- Location
- Sweden
ALF Foundation, Stockholm County Council (Sweden)
No information available
Sanofi-Aventis (Sweden)
No information available
Sanofi-Aventis (Austria)
No information available
Sanofi-Aventis (Germany)
No information available
Sanofi-Aventis (Europe)
No information available
Amgen (Sweden)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Amgen Inc., Applied Molecular Genetics Inc.
- Location
- United States of America
Amgen (Germany)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Amgen Inc., Applied Molecular Genetics Inc.
- Location
- United States of America
Amgen (Europe)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Amgen Inc., Applied Molecular Genetics Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/11/2016 | Yes | No | |
| Results article | results | 01/05/2020 | 02/04/2020 | Yes | No |
Editorial Notes
02/04/2020: Publication reference added.
10/11/2016: Publication reference added.
24/01/2011: This trial record was significantly altered to match the new protocol (other changes can be found under the relevant sections, with the above update date):
1. The public title was updated; the original public title was 'The SBG 2004-1/ABCSG 25 study (the SÖS study)'.
2. The acronym was changed; the original acronym was 'The SÖS study'.
3. Germany was also added to the countries of recruitment.
4. The overall trial end date was changed from 01/02/2010 to 01/08/2011.
5. The target number of participants was changed from 900 to 2000.
6. Sanofi-Aventis (Germany), Amgen (Germany) and Amgen (Europe) were added to the sources of funding field.
