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NCT00798070

PHASE3

Panther: A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients

Sponsor: Karolinska University Hospital

View on ClinicalTrials.gov

Summary

This is an adjuvant, open, prospective, randomized study to compare: A. Individually tailored and two weekly dosed epirubicin + cyclophosphamide followed by a three weeks break followed by biweekly and tailored docetaxel (dtEC→dtT) given every second week, to B. Fixed dosed and three weekly epirubicin, cyclophosphamide and 5-fluorouracil, followed by fixed dosed and three weekly docetaxel (FEC→T). Patients with primary node-positive or high risk lymph node negative breast cancer will be eligible for the study. The primary objective of the phase 3 study is to compare breast cancer relapse-free survival (BCRFS) between the dtEC→dtT and FE100C→T. To detect a five-year BCRFS difference of 0.710 to 0.790 about 1000 patients per arm will be needed. They will be recruited during four years and followed another two years for breast cancer events. Secondary objectives are to compare 1. Distant disease-free survival (DDFS) 2. Event-free survival and 3. Overall survival 4. Health-related quality of life and toxicity analyses according to CTC 5. Outcome in relation to tumour biological factors and polymorphism patterns 1. RFS in relation to the Sorlie classes using immunohistochemical markers and/or gene expression profiling comparing A vs B arm 2. RFS with receptor positive disease (analyzed in the local laboratories as described in the CRFs and also analyzed as continuous variables) in the comparison between the A- and B- arms. 3. RFS with high and low proliferation, respectively, (analyzed in the local laboratories as described in the CRFs and also analyzed as a continuous variable, or centrally analyzed), in the comparison between the A- and B-arms. 4. RFS in relation to HER-2/neu status (analyzed in the local laboratories as described in the CRFs) in the primary cancers in the comparison between the A- and B-arms and analyzed whether trastuzumab was given in sequence or concurrently. 5. RFS analyzed in relation to other molecular markers (e.g. gene expression profiling/ sequencing) in the primary cancers and SNPs signatures in normal DNA (related to toxicities for EC/FEC and docetaxel components, respectively, and given dose levels and outcome in relation to these factors and in relation QoL) to outcome per arm. 6. RFS analyzed in relation to tumour associated lymphocytes and Y-box binding protein in the comparison between the A- and B-arms. Tumour tissue will be obtained and stored for studies of prognostication and therapy prediction. Last patient randomized was September 2011.

Official title: A Randomised Phase 3 Study Comparing Biweekly and Tailored Epirubicin + Cyclophosphamide Followed by Biweekly Tailored Docetaxel Versus Three Weekly Epirubicin + Cyclophosphamide + 5-fluorouracil Followed by Docetaxel in Lymph Node Positive or High Risk Lymph Node Negative Breast Cancer Patients

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

2017

Start Date

2007-02

Completion Date

2028-01

Last Updated

2024-12-18

Healthy Volunteers

Conditions

Breast Cancer

Interventions

DRUG

dtEC→dtT

Individually tailored and two weekly dosed epirubicin (start dose 90mg/m2) + cyclophosphamide (start dose 600mg/m2) followed by a three weeks break followed by biweekly and tailored docetaxel (start dose 75mg/m2) given every second week. If toxicity measured by CTC-NCI criteria are grade 2 or less (except haematological toxicity) it will be possible to escalate doses

DRUG

FEC→T

Fixed dosed and three weekly epirubicin (100mg/m2), cyclophosphamide (500mg/m2) and 5-fluorouracil (500mg/m2), followed by fixed dosed and three weekly docetaxel (100mg/m2), no dose escalations.

Inclusion Criteria: * Histological proven invasive primary breast cancer, with at least 5 (recommended 10) removed axillary lymph nodes OR negative sentinel node biopsy performed for the node negative cohort. 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. * 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. * 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). * Macroscopically and microscopically free margins after radical surgery (no cancer cells at borders of resection). * No proven distant metastases (negative chest/pulmonary X-ray, bone scintigram (when clinical signs of skeletal metastases or elevated ALP) supplemented with normal conventional X-ray of hot spots, normal liver function test and haematological function tests; when abnormal values, CT or ultrasound of the liver, patient can be included if no metastases are demonstrated. * Female age 18-65. * Ambulant patients (ECOG 1 or less). * No major cardiovascular morbidity NYHA I or II. (Appendix 3). * Written informed consent according to the local ethics committee requirements. * 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). Exclusion Criteria: * Previous neo-adjuvant treatment. * Non-radical surgery (histopathological positive margins). * Proven distant metastases. * Pregnancy or lactation. * Other serious medical condition. * 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 \> 5 years since diagnosis can be included. * Abnormal laboratory values precluding the possibility to safely deliver the used cytotoxic agents in the study. * Hypersensitivity to drugs formulated in polysorbate 80. * Peripheral neuropathy grade ≥2.

Locations (80)

MUG - Med. Univ.-Klinik Graz

Graz, Austria

MUI - Univ. Klinik f. Frauenheilkunde, Innsbruck

Innsbruck, Austria

LKH Leoben

Leoben, Austria

AKH Linz

Linz, Austria

KH BHS Linz

Linz, Austria

LKH Rankweil

Rankweil, Austria

KH BHB St. Veit/Glan

Saint Veit/Glan, Austria

LKH Salzburg / PMU

Salzburg, Austria

Brustzentrum Hanusch-KH

Vienna, Austria

Klinikum Wels - Grieskirchen GmbH

Wels, Austria

Marienhospital

Aachen, Germany

Klinikum am Bruderwald

Bamberg, Germany

Klinikum Bayreuth

Bayreuth, Germany

HELIOS Klinikum

Berlin, Germany

Klinikum Bietigheim

Bietigheim, Germany

Johanniter Krankenhaus

Bonn, Germany

Universitätsfrauenklinik

Bonn, Germany

Klinikum Sindelfingen-Böblingen

Böblingen, Germany

Krankenhaus Celle

Celle, Germany

St. Elisabeth-KKH

Cologne, Germany

Klinikum Deggendorf

Deggendorf, Germany

Diakonissen Krankenhaus

Dresden, Germany

Gemeinschaftspraxis

Dresden, Germany

Krankenhaus St. Joseph-Stift

Dresden, Germany

Praxis Dr. Adhami

Erkelenz, Germany

Klinikum der J. W. Goethe Universität

Frankfurt am Main, Germany

Klinikum Frankfurt Höchst GmbH

Frankfurt am Main, Germany

Onkologische Gemeinschaftspraxis

Frankfurt am Main, Germany

Kreiskrankenhaus

Freudenstadt, Germany

Klinikum Fulda

Fulda, Germany

Onkologische Schwerpunktpraxis

Goslar, Germany

Krankenhaus St. Elisabeth und St. Barbara

Halle, Germany

Universitätsfrauenklinik

Halle, Germany

Klinikum Hameln

Hamelin, Germany

Henriettenstiftung

Hanover, Germany

Medizinische Hochschule

Hanover, Germany

Universität Heidelberg

Heidelberg, Germany

Klinikum Heilbronn

Heilbronn, Germany

Gemienschaftspraxis

Hildesheim, Germany

Universitätsfrauenklinik

Homburg, Germany

St. Vincentius Kliniken

Karlsruhe, Germany

Städtisches Klinikum

Karlsruhe, Germany

Elisabeth Krankenhaus

Kassel, Germany

Klinikum Kempten

Kempten, Germany

St. Vincenz Krankenhaus

Limburg, Germany

Onkologische Tagesklinik

Lohsa, Germany

Klinikum Ludwigsburg

Ludwigsburg, Germany

Ev. Krankenhaus

Ludwigsfelde, Germany

St. Vincenz und Elisabeth-Hospital

Mainz, Germany

Universitätsfrauenklinik

Mainz, Germany

Universitätsfrauenklinik

Mannheim, Germany

Klinikum Fichtelgebirge

Marktredwitz, Germany

Onkologische Praxis

Memmingen, Germany

Gemeinschaftspraxis Münster

Münster, Germany

Praxis am Klinikum Neumarkt

Neumarkt, Germany

Onkologische Praxis

Pinneberg, Germany

Klinikum am Steinenberg

Reutlingen, Germany

Klinikum Rheinfelden

Rheinfelden, Germany

Klinikum Schwerin

Schwerin, Germany

Gesellschaft für onkologische Studien

Troisdorf, Germany

Klinikum Tuttlingen

Tuttlingen, Germany

Universitätsfrauenklinik

Tübingen, Germany

Universitätsfrauenklinik

Ulm, Germany

Klinikum Villingen-Schwenningen

Villingen, Germany

Klinikum Weiden

Weiden, Germany

Klinikum Weinheim

Weinheim, Germany

Asklepios Paulinen Klinik

Wiesbaden, Germany

St. Josefs-Hospital

Wiesbaden, Germany

Stadtkrankenhaus

Worms, Germany

Central Hospital

Gävle, Sweden

Sahlgrenska University Hospital

Gothenburg, Sweden

Central Hospital

Karlstad, Sweden

Linköping University Hospital

Linköping, Sweden

Lund University Hospital

Lund, Sweden

Malmö General University Hospital

Malmo, Sweden

Örebro University Hospital

Örebro, Sweden

Karolinska University Hospital, Dept of Oncology

Stockholm, Sweden

Central Hospital

Sundsvall, Sweden

Norrlands University Hospital

Umeå, Sweden

Uppsala Academic Hospital

Uppsala, Sweden

Clinical Research Directory

Panther: A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (80)