Condition category
Cancer
Date applied
19/06/2007
Date assigned
14/08/2007
Last edited
10/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.kpeks.se/sbg20041

Contact information

Type

Scientific

Primary contact

Prof Jonas Bergh

ORCID ID

Contact details

Department of Oncology
Karolinska University Hospital
Stockholm
SE-171 76
Sweden

Additional identifiers

EudraCT number

2007-002061-12

ClinicalTrials.gov number

NCT00798070

Protocol/serial number

SBG 2004-1/ABCSG 25/GBG53

Study information

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

Acronym

The Panther Study

Study hypothesis

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

Regional Ethical Board in Stockholm (Regionala etikprövningsnämnden i Stockholm), 15/01/2007, ref: 04-647/1

Study design

Phase III open prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Phase III

Drug names

Epirubicin, cyclophosphamide, docetaxel, 5-fluorouracil

Primary outcome measures

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 trial start date

01/02/2007

Overall trial end date

01/08/2011

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2000

Participant 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

Recruitment start date

01/02/2007

Recruitment end date

01/08/2011

Locations

Countries of recruitment

Austria, Germany, Sweden

Trial participating centre

Karolinska University Hospital
Stockholm
SE-171 76
Sweden

Sponsor information

Organisation

Karolinska University Hospital

Sponsor details

c/o Prof Jonas Bergh
Radiumhemmet
Department of Oncology
Karolinska University Hospital
Stockholm
SE-171 76
Sweden
+46 (0)8 51770000
jonas.bergh@ki.se

Sponsor type

University/education

Website

Organisation

Paracelsus University

Sponsor details

c/o Richard Greil
MD
Professor
Austrian Breast & Colorectal Cancer Study Group (ABCSG)
Department of Internal Medicine III
Salzburg
A-5020
Austria

Sponsor type

University/education

Website

Organisation

Städt. Kliniken Frankfurt-Höchst

Sponsor details

c/o Volker Möbus
MD
Professor
German Breast Group (GBG)
Frauenklinik
Gotenstrasse 6-8
Frankfurt/Höchst
D-65929
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Swedish Cancer Society (Sweden)

Alternative name(s)

Swedish Cancer Society

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Funder name

ALF Foundation, Stockholm County Council (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sanofi-Aventis (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sanofi-Aventis (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sanofi-Aventis (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sanofi-Aventis (Europe)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Amgen (Sweden)

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Amgen (Germany)

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Amgen (Europe)

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27825007

Publication citations

Additional files

Editorial Notes

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.