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| Trial of PeriOperative Endocrine Therapy - Individualising Care |
| Source of record | UK Trials |
| ISRCTN | ISRCTN63882543 |
| Date ISRCTN assigned | 18/12/2007 |
| Local reference number(s) | ICR-CTSU/2007/10015 |
| Public title | Trial of PeriOperative Endocrine Therapy - Individualising Care |
| Scientific title | |
| Acronym | POETIC |
| Disease/condition/study domain | Early breast cancer |
| 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 |
| Design/methodology | Randomised phase III open-label clinical trial. |
| Research ethics review | Ethics approval not yet received as of 25/10/2007. |
| Countries of trial | United Kingdom |
| Participants - 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) |
| Participants - exclusion criteria | 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 |
| Patient information material | |
| Anticipated start date | 01/02/2008 |
| Anticipated end date | 01/05/2011 |
| Status of trial | Ongoing |
| Target number of participants | 4000 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | 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 |
| Sources of funding | Cancer Research UK (CRUK) (UK) (ref: C1491/A8671) |
| Sponsor name | Institute of Cancer Research (UK) |
| Sponsor details | c/o Barbara Pittam 123 Old Brompton Road London United Kingdom SW7 3RP |
| Sponsor website | http://www.icr.ac.uk/ |
| Contact name | Mrs Lindsay Johnson |
| Contact details | Section of Clinical Trials Institute of Cancer Research Sir Richard Doll Building Cotswold Road Sutton United Kingdom SM2 5NG |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN63882543 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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