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

Study acronym: PANTHER
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Study completion date: Jan 2022 to Jan 2028
    • Publications: 6 to 12
    v13
  2. Re-verified, no change to tracked fieldsv12
  3. Publications: 5 to 6v11
  4. Study sites: 11 to 80
    • Primary completion date changed from estimate of Dec 2021 to Apr 2016
    • Secondary endpoints: details revised at 1 of 6 entries
    • Publications: details revised at 1 of 5 entries
    v10
  5. Primary completion date: Jan 2013 to Dec 2021v9 Show 4 more changesShow less
    • Study completion date: Sep 2021 to Jan 2022
    • Interventions: Epirubicin, cyclophosphamide, 5-fluorouracil, docetaxel (Drug), Epirubicin, cyclophosphamide, docetaxel (Drug) to FEC→T (Drug), dtEC→dtT (Drug)
    • Secondary endpoints: 5 to 6
    • Study description expanded, about 7 words
Show 7 earlier versionsHide 7 earlier versions
  1. Secondary endpoints revised (5)v8
  2. Primary completion date: Jul 2011 to Jan 2013v7 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 2000 to confirmed 2017
    • Study completion date: Oct 2021 to Sep 2021
    • Site details revised at 11 of 11 sites
    • Collaborators: 2 to 3
  3. Primary completion date: Nov 2010 to Jul 2011
    • Enrollment target: 1524 to 2000
    • Study completion date: Oct 2020 to Oct 2021
    • Eligibility criteria expanded, about 32 words
    v6
  4. Study sites: 10 to 11
    • Primary completion date: May 2010 to Nov 2010
    • Study completion date: Oct 2020
    • Secondary endpoints: details revised at 1 of 5 entries
    v5
  5. Primary completion date: Mar 2010 to May 2010
    • Collaborators: 3 to 2
    v4
  6. Site contacts updated at 3 of 10 sitesv3
  7. Study title expanded, about 1 wordv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00798070
Lead Sponsor Karolinska University Hospital
Collaborators: Swedish Breast Cancer Group, Austrian Breast & Colorectal Cancer Study Group, GBG Forschungs GmbH
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Neoplasms
Enrollment 2,017 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov