Persephone: duration of Herceptin with chemotherapy 6 versus 12 months

ISRCTN ISRCTN52968807
DOI https://doi.org/10.1186/ISRCTN52968807
EudraCT/CTIS number 2006-007018-39
ClinicalTrials.gov number NCT00712140
Secondary identifying numbers HTA 06/303/98
Submission date
09/02/2007
Registration date
13/02/2007
Last edited
07/09/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

http://www.cancerhelp.org.uk/trials/a-trial-comparing-6-months-and-12-months-of-trastuzumab-for-early-breast-cancer

Study website

Contact information

Dr Helena Earl
Scientific

Oncology Department
Box 193
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Phone +44 (0)1223 274312
Email hme22@cam.ac.uk

Study information

Study designPhase III randomised multi-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titlePersephone: duration of Herceptin with chemotherapy 6 versus 12 months
Study acronymPersephone
Study hypothesisDoes 6 months of trastuzumab (Herceptin®) treatment prevent breast cancer relapse (disease-free survival [DFS]) as well as 12 months of trastuzumab treatment? To test the hypothesis that reducing the duration of adjuvant trastuzumab to 6 months from 12 months, in 4,000 patients (updated 08/10/2014: originally women only) with HER-2 positive early breast cancer, produces equivalent (non-inferior) disease-free and overall survival outcomes.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0630398
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0016/51334/PRO-06-303-98.pdf

On 15/01/2008 the overall trial end date was changed from 01/04/2011 to 31/03/2013.

On 08/10/2014 the overall trial end date was changed from 30/09/2014 to 30/06/2015.
Ethics approval(s)North West Research Ethics Committee, 09/08/2007, ref: 07/MRE08/35
ConditionHER2-positive early breast cancer
InterventionCurrent interventions as of 08/10/2014:
Patients will receive during or after a standard regimen of chemotherapy either:
1. The standard treatment, i.e. a dose every 3 weeks for a year (18 doses) or
2. The research treatment, i.e. 9 doses over 6 months

The starting dose of IV trastuzumab is 8 mg/kg. The maintenance dose is 6 mg/kg.
All doses of sub-cut trastuzumab are 6 mg/kg.

Previous interventions:
Patients will receive during or after a standard regimen of chemotherapy either:
1. The standard treatment, i.e. a dose every 3 weeks for a year (17 doses) or
2. The research treatment, i.e. 9 doses over 6 months

The starting dose of trastuzumab is 8 mg/kg. The maintenance dose is 6 mg/kg.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Herceptin (trastuzumab)
Primary outcome measureDisease-free survival non-inferiority (equivalence) of 6 months trastuzumab to 12 months in early breast cancer
Secondary outcome measures1. Does 6 months of trastuzumab treatment prevent breast cancer death as well as 12 months of trastuzumab treatment?
2. What is the health economic costs and the quality of life for patients receiving 6 months versus 12 months of trastuzumab treatment?

Research will also be conducted through the collection of tissue samples
Updated 08/10/2014: Research will also be conducted through the collection of blood and tissue samples
Overall study start date01/04/2007
Overall study end date30/06/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants4,000
Total final enrolment4089
Participant inclusion criteria1. Histological diagnosis of invasive breast cancer
2. No evidence of metastatic disease
3. Known hormone receptor status
4. Overexpression of HER-2 positive: 3+ overexpression by immunohistochemistry (IHC) or 2+ overexpression by IHC and fluorescence in situ hybridisation (FISH) test positive
5. Clear indication for chemotherapy based on clinical and histopathological features
6. Patient fit to receive any of the trial chemotherapy regimens
7. Patient must not have clinically significant cardiac abnormalities and must not have had a previous myocardial infarction during the 6 months prior to recruitment. Cardiac function should be assessed by physical examination and electrocardiogram (ECG)
8. Patient must have adequate bone marrow, hepatic, and renal function
9. No previous chemotherapy or radiotherapy
10. No previous diagnosis of malignancy unless:
10.1. Managed by surgical treatment only, and disease-free for 10 years
10.2. Previous basal cell carcinoma, cervical carcinoma in situ or ductal carcinoma in situ of the breast treated by surgery only
11. Non-pregnant and non-lactating
12. No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up
13. Patients 18 years or older (updated 08/10/2014; originally women only)
14. Written informed consent for the study
Participant exclusion criteria1. Non-controlled or malignant arterial high-pressure
2. Clinically significant cardiac disease. Cardiac left ventricular ejection fraction below normal range
3. History of atrio-ventricular arrhythmias and/or congestive heart failure, even where it is under medical control, or active second- or third-degree cardiac block. History of myocardial infarct during the 6 months prior to recruitment.
4. Any co-morbidity significantly adding to risks associated with cytotoxic chemotherapy, for instance: severe chronic obstructive pulmonary disease, poorly controlled diabetes, etc.
5. History of allergy to drugs containing polysorbate 20 and the excipient TWEEN 80® and history of allergy to mouse proteins
6. Inability to comply with protocol requirements
Recruitment start date04/10/2007
Recruitment end date30/06/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge Hospitals NHS Foundation Trust and Cambridge University (UK)
Hospital/treatment centre

R&D Department box 126
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone +44 (0)1223 274486
Email claudia.rizzini@addenbrookes.nhs.uk
ROR logo "ROR" https://ror.org/04v54gj93

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 20/05/2014 Yes No
Results article results 29/06/2019 11/06/2019 Yes No
Results article results 01/08/2020 07/09/2020 Yes No

Editorial Notes

07/09/2020: Publication reference added.
11/06/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.