Persephone: duration of Herceptin with chemotherapy 6 versus 12 months
ISRCTN | ISRCTN52968807 |
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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
Contact information
Dr Helena Earl
Scientific
Scientific
Oncology Department
Box 193
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Phone | +44 (0)1223 274312 |
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hme22@cam.ac.uk |
Study information
Study design | Phase III randomised multi-centre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Persephone: duration of Herceptin with chemotherapy 6 versus 12 months |
Study acronym | Persephone |
Study hypothesis | Does 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 |
Condition | HER2-positive early breast cancer |
Intervention | Current 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 type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Herceptin (trastuzumab) |
Primary outcome measure | Disease-free survival non-inferiority (equivalence) of 6 months trastuzumab to 12 months in early breast cancer |
Secondary outcome measures | 1. 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 date | 01/04/2007 |
Overall study end date | 30/06/2015 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 4,000 |
Total final enrolment | 4089 |
Participant inclusion criteria | 1. 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 criteria | 1. 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 date | 04/10/2007 |
Recruitment end date | 30/06/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge Hospitals NHS Foundation Trust and Cambridge University (UK)
Hospital/treatment centre
Hospital/treatment centre
R&D Department box 126
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
Phone | +44 (0)1223 274486 |
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claudia.rizzini@addenbrookes.nhs.uk | |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.