Condition category
Cancer
Date applied
09/02/2007
Date assigned
13/02/2007
Last edited
05/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Helena Earl

ORCID ID

Contact details

Oncology Department
Box 193
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 274312
hme22@cam.ac.uk

Additional identifiers

EudraCT number

2006-007018-39

ClinicalTrials.gov number

NCT00712140

Protocol/serial number

HTA 06/303/98

Study information

Scientific title

Persephone: duration of herceptin with chemotherapy 6 versus 12 months

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

North West Research Ethics Committee, 09/08/2007, ref: 07/MRE08/35

Study design

Phase III randomised multi-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Phase III

Drug names

Herceptin

Primary outcome measures

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 trial start date

01/04/2007

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

4,000

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

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge Hospitals NHS Foundation Trust and Cambridge University (UK)

Sponsor details

R&D Department box 126
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 274486
claudia.rizzini@addenbrookes.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in:
Hiller L et al. Cardiology monitoring substudy in the PERSEPHONE trial: 6 versus 12 months of Trastuzumab. J Clin Oncol 32:5s, 2014 (suppl; abstr 552)

Publication citations

Additional files

Editorial Notes