The SBG 2004-1/ABCSG 25/GBG53 study (the Panther study)

Phase 3

Completed

• Conditions: ymph node positive breast cancer patients; Cancer; Malignant neoplasm of the breast

• Registration Number: ISRCTN39017665
• Lead Sponsor: Karolinska University Hospital

Brief Summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27825007 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32232698 (added 02/04/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-14
• Study Completion: 2011-08-01
• Last Update Posted: 27 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2000

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified