Condition category
Cancer
Date applied
25/10/2007
Date assigned
18/12/2007
Last edited
03/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Hannah Baber

ORCID ID

Contact details

Clinical Trial Coordinator
ICR Clinical Trials & Statistics Unit (ICR-CTSU)
Section of Clinical Trials
The Institute of Cancer Research
Sir Richard Doll Building
Cotswold Road
Sutton
SM2 5NG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ICR-CTSU/2007/10015

Study information

Scientific title

Trial of PeriOperative Endocrine Therapy - Individualising Care

Acronym

POETIC

Study hypothesis

1. That peri-operative endocrine therapy with an aromatase inhibitor for two weeks before and after surgery (perioperative therapy) followed by standard adjuvant therapy improves outcome compared with standard therapy alone in postmenopausal women with hormone receptor positive breast cancer
2. That the proliferation marker Ki67 as measured by Immunohistochemistry (IHC) in the excised cancer around 2 weeks after starting aromatase inhibitor therapy will predict for relapse free survival (Disease-Free Survival [DFS]) more effectively than the pre-treatment Ki67 value in the individual patient

Please note that as of 07/05/2008, the anticipated start and end dates of this trial were updated. The previous anticipated start and end dates were 01/02/2008 and 01/05/2011 respectively.

Please note that as of 10/10/2012, the anticipated end date for this trial was updated from 01/10/2011 to 01/02/2013

Ethics approval

South East Research Ethics Committee on 16/04/2008 (ref: 08/H1102/37).

Study design

Randomised phase III open-label clinical trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Early breast cancer

Intervention

Patients will be randomised in the ratio of 2:1 to receive anastozole 1 mg or letrozole 2.5 mg daily, taken orally for 4 weeks, commencing 2 weeks before surgery for primary breast cancer. Patients will be followed up long term, i.e., at least 5 years to satisfy primary endpoint of relapse free survival.

The Royal Marsden NHS Foundation Trust is a co-sponsor of this trial.

Intervention type

Drug

Phase

Phase III

Drug names

Anastrozole, letrozole

Primary outcome measures

Current primary outcome measures as of 11/10/2012:
Relapse free survival (clinical endpoint)

Previous primary outcome measures until 11/10/2012:
1. 5-year relapse free survival, planned for mid-2016
2. Proliferation rate (Ki67) at baseline core biopsy, and at surgical excision (both groups) to determine the relative accuracy of baseline and 2 week Ki67 in predicting outcome using pre-treatment and on-treatment values

Secondary outcome measures

Current secondary outcome measures as of 11/10/2012:
1. Time to local recurrence
2. Time to distant recurrence
3. Overall survival, planned for mid-2016
4. Gene expression profile at core biopsy and at surgical excision (both groups) to determine the relative accuracy of baseline and 2 week profiles in predicting outcome with pre-treatment and on-treatment
5. Proliferation rate (Ki67) at baseline core biopsy, and at surgical excision (biological endpoint)

Previous secondary outcome measures until 11/10/2012:
1. Time to local recurrence
2. Time to distant recurrence
3. Overall survival, planned for mid-2016
4. Gene expression profile at core biopsy and at surgical excision (both groups) to determine the relative accuracy of baseline and 2 week profiles in predicting outcome with pre-treatment and on-treatment

Overall trial start date

01/08/2008

Overall trial end date

01/02/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Postmenopausal women with core biopsy-proven hormone receptor positive invasive breast cancer. Postmenopausal is defined as a woman fulfilling any one of the following criteria:
1.1. Aged greater than 50 years with amenorrhoea greater than 12 months and an intact uterus
1.2. Has undergone a bilateral oophorectomy
1.3. In women who have undergone a hysterectomy, then Follicle Stimulating Hormone (FSH) levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged less than 55 years
1.4. In women who have been on Hormone Replacement Therapy (HRT) within the last 12 months and therefore not amenorrhoeic, FSH levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged less than 55 years
2. No evidence of metastatic spread by standard assessment according to local guidelines
3. Standard adjuvant endocrine therapy indicated
4. A palpable tumour of any minimum size, or a tumour with an ultrasound size of at least 1.5 cm
5. World Health Organization (WHO) performance status of 0, 1, or 2
6. Written informed consent to participate in the trial and to donation of tissue (fresh tissue and surplus tissue from diagnostic procedures)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

4000

Participant exclusion criteria

Current exclusion criteria as of 11/10/2012:
1. Locally advanced/inoperable breast cancer
2. Evidence of metastatic disease
3. Concurrent use of HRT
4. Prior endocrine therapy for breast cancer
5. Neoadjuvant chemotherapy
6. Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ)
7. Any severe coincident medical disease or inability to give informed consent
8. Treatment with a non-approved or investigational drug within 4 weeks before randomisation
9. Previous invasive breast cancer or bilateral breast cancer (surgically treated DCIS or LCIS allowed)
10. Previous use of oestrogen implants at ANY time
11. Continuous long term systemic steroid usage

Previous exclusion criteria until 11/10/2012:
1. Locally advanced/inoperable breast cancer
2. Evidence of metastatic disease
3. Concurrent use of HRT
4. Prior endocrine therapy for breast cancer
5. Neoadjuvant chemotherapy
6. Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ)
7. Any severe coincident medical disease or inability to give informed consent
8. Treatment with a non-approved or investigational drug within 4 weeks before randomisation

Recruitment start date

01/08/2008

Recruitment end date

01/02/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trial Coordinator
Sutton
SM2 5NG
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (UK)

Sponsor details

c/o Barbara Pittam
123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Research organisation

Website

http://www.icr.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C1491/A8671)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes

03/05/2016: No publications found, verifying study status with principal investigator.