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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dtEC→dtT
FEC→T
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Lymph node positive or high risk lymph node negative breast, cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • MUG - Med. Univ.-Klinik Graz
  • MUI - Univ. Klinik f. Frauenheilkunde, Innsbruck
  • LKH Leoben
  • AKH Linz
  • KH BHS Linz
  • LKH Rankweil
  • LKH Salzburg / PMU
  • KH BHB St. Veit/Glan
  • Klinikum Wels - Grieskirchen GmbH
  • Brustzentrum Hanusch-KH
  • Marienhospital
  • Klinikum am Bruderwald
  • Klinikum Bayreuth
  • HELIOS Klinikum
  • Klinikum Bietigheim
  • Klinikum Sindelfingen-Böblingen
  • Johanniter Krankenhaus
  • Universitätsfrauenklinik
  • Krankenhaus Celle
  • Klinikum Deggendorf
  • Diakonissen Krankenhaus
  • Gemeinschaftspraxis
  • Krankenhaus St. Joseph-Stift
  • Praxis Dr. Adhami
  • Klinikum der J. W. Goethe Universität
  • Klinikum Frankfurt Höchst GmbH
  • Onkologische Gemeinschaftspraxis
  • Kreiskrankenhaus
  • Klinikum Fulda
  • Onkologische Schwerpunktpraxis
  • Krankenhaus St. Elisabeth und St. Barbara
  • Universitätsfrauenklinik
  • Klinikum Hameln
  • Henriettenstiftung
  • Medizinische Hochschule
  • Universität Heidelberg
  • Klinikum Heilbronn
  • Gemienschaftspraxis
  • Universitätsfrauenklinik
  • St. Vincentius Kliniken
  • Städtisches Klinikum
  • Elisabeth Krankenhaus
  • Klinikum Kempten
  • St. Elisabeth-KKH
  • St. Vincenz Krankenhaus
  • Onkologische Tagesklinik
  • Klinikum Ludwigsburg
  • Ev. Krankenhaus
  • St. Vincenz und Elisabeth-Hospital
  • Universitätsfrauenklinik
  • Universitätsfrauenklinik
  • Klinikum Fichtelgebirge
  • Onkologische Praxis
  • Gemeinschaftspraxis Münster
  • Praxis am Klinikum Neumarkt
  • Onkologische Praxis
  • Klinikum am Steinenberg
  • Klinikum Rheinfelden
  • Klinikum Schwerin
  • Gesellschaft für onkologische Studien
  • Klinikum Tuttlingen
  • Universitätsfrauenklinik
  • Universitätsfrauenklinik
  • Klinikum Villingen-Schwenningen
  • Klinikum Weiden
  • Klinikum Weinheim
  • Asklepios Paulinen Klinik
  • St. Josefs-Hospital
  • Stadtkrankenhaus
  • Central Hospital
  • Sahlgrenska University Hospital
  • Central Hospital
  • Linköping University Hospital
  • Lund University Hospital
  • Malmö General University Hospital
  • Karolinska University Hospital, Dept of Oncology
  • Central Hospital
  • Norrlands University Hospital
  • Uppsala Academic Hospital
  • Örebro University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: dtEC→dtT

Arm B: FEC→T

Arm Description

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

Fixed dosed and three weekly epirubicin, cyclophosphamide and 5-fluorouracil, followed by fixed dosed and three weekly docetaxel

Outcomes

Primary Outcome Measures

Breast cancer relapse-free survival
Breast cancer recurrence free survival is defined as time from randomization to the first of the events; local-, regional- or distant breast cancer recurrence or death due to breast cancer or last date of follow-up if no event has occurred. This was defined already in the phase 2 protocol (1 Sept 2004).

Secondary Outcome Measures

Distant disease-free survival
Distant disease free survival is defined as time from randomization to the first of distant metastases or death due to breast cancer.
Event-free survival
Event-free survival is defined as time from randomization to the first of the events breast cancer recurrence (any type), contra-lateral breast cancer, other malignancy or any cause of death.
Overall survival
Overall survival is defined as time from randomization to any death.
Health-related quality of life and toxicity analyses according to CTC
Outcome in relation to tumour biological factors and polymorphism patterns
Comparing arm A vs B regarding: RFS in relation to the Sorlie classes using immunohistochemical markers and/or gene expression profiling comparing A vs B arm; RFS with receptor positive disease in the comparison between the A- and B arms; RFS with high and low proliferation, respectively, in the comparison between the A- and B-arms.; RFS in relation to HER-2/neu status in the primary cancers in the comparison between the A- and B-arms and analyzed whether trastuzumab was given in sequence or concurrently; RFS analyzed in relation to other molecular markers in the primary cancers and SNPs signatures in normal DNA to outcome per arm; RFS analyzed in relation to tumour associated lymphocytes and Y-box binding protein in the comparison between the A- and B-arms. Description of a to e are more detailed in the protocol, shortened here due to space limitation.
BCRFS in arm A in relation to given dose levels
Breast cancer relapse free survival

Full Information

First Posted
November 24, 2008
Last Updated
September 2, 2020
Sponsor
Karolinska University Hospital
Collaborators
Swedish Breast Cancer Group, Austrian Breast & Colorectal Cancer Study Group, German Breast Group
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1. Study Identification

Unique Protocol Identification Number
NCT00798070
Brief Title
Panther: A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients
Acronym
PANTHER
Official Title
PANTHER. A Randomized Phase 3 Study Comparing Biweekly and Tailored Epirubicin + Cyclophosphamide Followed by Biweekly Tailored Docetaxel (dtEC→dtT) Versus Three Weekly Epirubicin + Cyclophosphamide + 5-fluorouracil Followed by Docetaxel (FEC→T) in Lymph Node Positive or High Risk Lymph Node Negative Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Swedish Breast Cancer Group, Austrian Breast & Colorectal Cancer Study Group, German Breast Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 Distant disease-free survival (DDFS) Event-free survival and Overall survival Health-related quality of life and toxicity analyses according to CTC Outcome in relation to tumour biological factors and polymorphism patterns RFS in relation to the Sorlie classes using immunohistochemical markers and/or gene expression profiling comparing A vs B arm 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. 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. 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. 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. 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.
Detailed Description
Are described under the heading "Outcome measures"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Lymph node positive or high risk lymph node negative breast, cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2017 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: dtEC→dtT
Arm Type
Experimental
Arm Description
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
Arm Title
Arm B: FEC→T
Arm Type
Active Comparator
Arm Description
Fixed dosed and three weekly epirubicin, cyclophosphamide and 5-fluorouracil, followed by fixed dosed and three weekly docetaxel
Intervention Type
Drug
Intervention Name(s)
dtEC→dtT
Other Intervention Name(s)
Epirubicin, Cyclophosphamide, Taxotere
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
FEC→T
Other Intervention Name(s)
Epirubicin, Cyclophosphamide, Fluorouracil, Taxotere
Intervention Description
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.
Primary Outcome Measure Information:
Title
Breast cancer relapse-free survival
Description
Breast cancer recurrence free survival is defined as time from randomization to the first of the events; local-, regional- or distant breast cancer recurrence or death due to breast cancer or last date of follow-up if no event has occurred. This was defined already in the phase 2 protocol (1 Sept 2004).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Distant disease-free survival
Description
Distant disease free survival is defined as time from randomization to the first of distant metastases or death due to breast cancer.
Time Frame
2 years
Title
Event-free survival
Description
Event-free survival is defined as time from randomization to the first of the events breast cancer recurrence (any type), contra-lateral breast cancer, other malignancy or any cause of death.
Time Frame
2 years
Title
Overall survival
Description
Overall survival is defined as time from randomization to any death.
Time Frame
2 years
Title
Health-related quality of life and toxicity analyses according to CTC
Time Frame
2 years
Title
Outcome in relation to tumour biological factors and polymorphism patterns
Description
Comparing arm A vs B regarding: RFS in relation to the Sorlie classes using immunohistochemical markers and/or gene expression profiling comparing A vs B arm; RFS with receptor positive disease in the comparison between the A- and B arms; RFS with high and low proliferation, respectively, in the comparison between the A- and B-arms.; RFS in relation to HER-2/neu status in the primary cancers in the comparison between the A- and B-arms and analyzed whether trastuzumab was given in sequence or concurrently; RFS analyzed in relation to other molecular markers in the primary cancers and SNPs signatures in normal DNA to outcome per arm; RFS analyzed in relation to tumour associated lymphocytes and Y-box binding protein in the comparison between the A- and B-arms. Description of a to e are more detailed in the protocol, shortened here due to space limitation.
Time Frame
2 years
Title
BCRFS in arm A in relation to given dose levels
Description
Breast cancer relapse free survival
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonas Bergh, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUG - Med. Univ.-Klinik Graz
City
Graz
Country
Austria
Facility Name
MUI - Univ. Klinik f. Frauenheilkunde, Innsbruck
City
Innsbruck
Country
Austria
Facility Name
LKH Leoben
City
Leoben
Country
Austria
Facility Name
AKH Linz
City
Linz
Country
Austria
Facility Name
KH BHS Linz
City
Linz
Country
Austria
Facility Name
LKH Rankweil
City
Rankweil
Country
Austria
Facility Name
LKH Salzburg / PMU
City
Salzburg
Country
Austria
Facility Name
KH BHB St. Veit/Glan
City
St. Veit/Glan
Country
Austria
Facility Name
Klinikum Wels - Grieskirchen GmbH
City
Wels
Country
Austria
Facility Name
Brustzentrum Hanusch-KH
City
Wien
Country
Austria
Facility Name
Marienhospital
City
Aachen
Country
Germany
Facility Name
Klinikum am Bruderwald
City
Bamberg
Country
Germany
Facility Name
Klinikum Bayreuth
City
Bayreuth
Country
Germany
Facility Name
HELIOS Klinikum
City
Berlin
Country
Germany
Facility Name
Klinikum Bietigheim
City
Bietigheim
Country
Germany
Facility Name
Klinikum Sindelfingen-Böblingen
City
Boblingen
Country
Germany
Facility Name
Johanniter Krankenhaus
City
Bonn
Country
Germany
Facility Name
Universitätsfrauenklinik
City
Bonn
Country
Germany
Facility Name
Krankenhaus Celle
City
Celle
Country
Germany
Facility Name
Klinikum Deggendorf
City
Deggendorf
Country
Germany
Facility Name
Diakonissen Krankenhaus
City
Dresden
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Dresden
Country
Germany
Facility Name
Krankenhaus St. Joseph-Stift
City
Dresden
Country
Germany
Facility Name
Praxis Dr. Adhami
City
Erkelenz
Country
Germany
Facility Name
Klinikum der J. W. Goethe Universität
City
Frankfurt am Main
Country
Germany
Facility Name
Klinikum Frankfurt Höchst GmbH
City
Frankfurt am Main
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis
City
Frankfurt am Main
Country
Germany
Facility Name
Kreiskrankenhaus
City
Freudenstadt
Country
Germany
Facility Name
Klinikum Fulda
City
Fulda
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Goslar
Country
Germany
Facility Name
Krankenhaus St. Elisabeth und St. Barbara
City
Halle
Country
Germany
Facility Name
Universitätsfrauenklinik
City
Halle
Country
Germany
Facility Name
Klinikum Hameln
City
Hameln
Country
Germany
Facility Name
Henriettenstiftung
City
Hannover
Country
Germany
Facility Name
Medizinische Hochschule
City
Hannover
Country
Germany
Facility Name
Universität Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Klinikum Heilbronn
City
Heilbronn
Country
Germany
Facility Name
Gemienschaftspraxis
City
Hildesheim
Country
Germany
Facility Name
Universitätsfrauenklinik
City
Homburg
Country
Germany
Facility Name
St. Vincentius Kliniken
City
Karlsruhe
Country
Germany
Facility Name
Städtisches Klinikum
City
Karlsruhe
Country
Germany
Facility Name
Elisabeth Krankenhaus
City
Kassel
Country
Germany
Facility Name
Klinikum Kempten
City
Kempten
Country
Germany
Facility Name
St. Elisabeth-KKH
City
Köln
Country
Germany
Facility Name
St. Vincenz Krankenhaus
City
Limburg
Country
Germany
Facility Name
Onkologische Tagesklinik
City
Lohsa
Country
Germany
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
Country
Germany
Facility Name
Ev. Krankenhaus
City
Ludwigsfelde
Country
Germany
Facility Name
St. Vincenz und Elisabeth-Hospital
City
Mainz
Country
Germany
Facility Name
Universitätsfrauenklinik
City
Mainz
Country
Germany
Facility Name
Universitätsfrauenklinik
City
Mannheim
Country
Germany
Facility Name
Klinikum Fichtelgebirge
City
Marktredwitz
Country
Germany
Facility Name
Onkologische Praxis
City
Memmingen
Country
Germany
Facility Name
Gemeinschaftspraxis Münster
City
Münster
Country
Germany
Facility Name
Praxis am Klinikum Neumarkt
City
Neumarkt
Country
Germany
Facility Name
Onkologische Praxis
City
Pinneberg
Country
Germany
Facility Name
Klinikum am Steinenberg
City
Reutlingen
Country
Germany
Facility Name
Klinikum Rheinfelden
City
Rheinfelden
Country
Germany
Facility Name
Klinikum Schwerin
City
Schwerin
Country
Germany
Facility Name
Gesellschaft für onkologische Studien
City
Troisdorf
Country
Germany
Facility Name
Klinikum Tuttlingen
City
Tuttlingen
Country
Germany
Facility Name
Universitätsfrauenklinik
City
Tübingen
Country
Germany
Facility Name
Universitätsfrauenklinik
City
Ulm
Country
Germany
Facility Name
Klinikum Villingen-Schwenningen
City
Villingen
Country
Germany
Facility Name
Klinikum Weiden
City
Weiden
Country
Germany
Facility Name
Klinikum Weinheim
City
Weinheim
Country
Germany
Facility Name
Asklepios Paulinen Klinik
City
Wiesbaden
Country
Germany
Facility Name
St. Josefs-Hospital
City
Wiesbaden
Country
Germany
Facility Name
Stadtkrankenhaus
City
Worms
Country
Germany
Facility Name
Central Hospital
City
Gävle
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Göteborg
Country
Sweden
Facility Name
Central Hospital
City
Karlstad
Country
Sweden
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Facility Name
Lund University Hospital
City
Lund
Country
Sweden
Facility Name
Malmö General University Hospital
City
Malmö
Country
Sweden
Facility Name
Karolinska University Hospital, Dept of Oncology
City
Stockholm
Country
Sweden
Facility Name
Central Hospital
City
Sundsvall
Country
Sweden
Facility Name
Norrlands University Hospital
City
Umeå
Country
Sweden
Facility Name
Uppsala Academic Hospital
City
Uppsala
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Oral presentation at ASCO 4 June 2016 (completed).
Citations:
Citation
Bergh J. Oral presentation, ASCO Annual Meeting 2016.
Results Reference
background
PubMed Identifier
27825007
Citation
Foukakis T, von Minckwitz G, Bengtsson NO, Brandberg Y, Wallberg B, Fornander T, Mlineritsch B, Schmatloch S, Singer CF, Steger G, Egle D, Karlsson E, Carlsson L, Loibl S, Untch M, Hellstrom M, Johansson H, Anderson H, Malmstrom P, Gnant M, Greil R, Mobus V, Bergh J; Swedish Breast Cancer Group (SweBCG), the German Breast Group (GBG), and the Austrian Breast & Colorectal Cancer Study Group (ABCSG). Effect of Tailored Dose-Dense Chemotherapy vs Standard 3-Weekly Adjuvant Chemotherapy on Recurrence-Free Survival Among Women With High-Risk Early Breast Cancer: A Randomized Clinical Trial. JAMA. 2016 Nov 8;316(18):1888-1896. doi: 10.1001/jama.2016.15865.
Results Reference
result
PubMed Identifier
32232698
Citation
Brandberg Y, Johansson H, Hellstrom M, Gnant M, Mobus V, Greil R, Foukakis T, Bergh J; Swedish Breast Cancer Group, the Austrian Breast, Colorectal Cancer Study Group, the German Breast Cancer Group. Long-term (up to 16 months) health-related quality of life after adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy in women with high-risk early breast cancer. Breast Cancer Res Treat. 2020 May;181(1):87-96. doi: 10.1007/s10549-020-05602-9. Epub 2020 Mar 31.
Results Reference
derived
PubMed Identifier
31851385
Citation
Papakonstantinou A, Matikas A, Bengtsson NO, Malmstrom P, Hedayati E, Steger G, Untch M, Hubbert L, Johansson H, Hellstrom M, Gnant M, Loibl S, Greil R, Moebus V, Foukakis T, Bergh J. Efficacy and safety of tailored and dose-dense adjuvant chemotherapy and trastuzumab for resected HER2-positive breast cancer: Results from the phase 3 PANTHER trial. Cancer. 2020 Mar 15;126(6):1175-1182. doi: 10.1002/cncr.32653. Epub 2019 Dec 18.
Results Reference
derived
PubMed Identifier
30357310
Citation
Matikas A, Foukakis T, Moebus V, Greil R, Bengtsson NO, Steger GG, Untch M, Johansson H, Hellstrom M, Malmstrom P, Gnant M, Loibl S, Bergh J. Dose tailoring of adjuvant chemotherapy for breast cancer based on hematologic toxicities: further results from the prospective PANTHER study with focus on obese patients. Ann Oncol. 2019 Jan 1;30(1):109-114. doi: 10.1093/annonc/mdy475.
Results Reference
derived
Links:
URL
http://www.kpeks.se/sbg20041
Description
Swedish website for the study

Learn more about this trial

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

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