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Trial of Perioperative Endocr...

Trial of Perioperative Endocrine Therapy - Individualising Care

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

4486 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2034-04-30

Brief Summary

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To determine whether perioperative endocrine therapy with an aromatase inhibitor (AI) followed by standard adjuvant therapy improves outcome compared with standard adjuvant therapy alone in postmenopausal women with hormone receptor positive breast cancer.

To determine whether the proliferation marker Ki67 as measured by immunohistochemistry (IHC) in the excised cancer around 2 weeks after starting AI therapy will predict for time to recurrence (TTR) in the individual patient more effectively than the pre-treatment Ki67 value.

To determine whether molecular profiling 2 weeks after starting endocrine therapy predicts for long-term outcome in postmenopausal women with hormone receptor positive breast cancer better than at diagnosis.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Aromatase Inhibitor

No aromatase inhibitor given around the time of surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Aromatase Inhibitor

Aromatase Inhibitor given perioperatively for 4 weeks (two weeks before and two weeks after surgery) Choice of AI is according to centre policy and may be either anastrozole (1mg/day) or letrozole (2.5mg/day)

Group Type EXPERIMENTAL

Aromatase Inhibitors

Intervention Type DRUG

Choice of AI is according to centre policy; any brand can be used

Interventions

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Aromatase Inhibitors

Choice of AI is according to centre policy; any brand can be used

Intervention Type DRUG

Other Intervention Names

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Anastrazole Letrozole

Eligibility Criteria

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Inclusion Criteria

1. Post menopausal women with core biopsy-proven hormone receptor positive invasive breast cancer. Postmenopausal is defined as a woman aged ≥50 years fulfilling any one of the following criteria:

i) with amenorrhoea \>12 months and an intact uterus; ii) has undergone a bilateral oophorectomy; iii) in women who have undergone a hysterectomy, then FSH levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged \<55 years; or iv) in women who have been on 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 \<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 size , or a tumour with an ultrasound size of at least 1.5cm
5. WHO performance status of 0 or 1
6. Written informed consent to participate in the trial and to donation of tissue (fresh tissue and surplus tissue from diagnostic procedures) and blood samples.

Exclusion Criteria

1. Locally advanced/inoperable breast cancer
2. Evidence of metastatic disease
3. Previous invasive breast cancer (surgically treated DCIS or LCIS allowed)
4. Current bilateral breast cancer
5. Multiple unilateral tumours with different ER/PgR/HER2 status, grade or type (e.g. ductal vs lobular) i.e. anything that suggests two or more different cancers. Multifocal disease with homogenous ER/PgR/HER2 status, grade and type is allowed if at least one lesion is palpable or at least 1.5cm on ultrasound; the largest lesion should be used for sample collection and CRF completion.
6. Concurrent use (defined as use within 4 weeks prior to diagnostic tissue sample being taken) of HRT or any other oestrogen-containing medication (including vaginal oestrogens)
7. Previous use of oestrogen implants at ANY time
8. Prior endocrine therapy or chemotherapy for breast cancer
9. Any invasive malignancy diagnosed within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ)
10. Any severe co-incident medical disease, inability to give informed consent or unavailability for follow-up
11. Treatment with an unlicensed or investigational drug within 4 weeks before randomisation
12. Current, continuous, long term systemic steroid usage

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian Smith, Professor

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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Ulster Hospital

Dundonald, Belfast, United Kingdom

Site Status

Heatherwood and Wexham Park Hospitals NHS trust

Slough, Berkshire, United Kingdom

Site Status

Stoke Mandeville Hospital

Aylesbury, Buckinghamshire, United Kingdom

Site Status

Prince Philip Hospital

Llanelli, Carmarthenshire, United Kingdom

Site Status

Craigavon Area Hospital

Portadown, Co.Amagh, United Kingdom

Site Status

Wansbeck General Hospital

Ashington, England, United Kingdom

Site Status

North Devon District Hospital

Barnstaple, England, United Kingdom

Site Status

City Hospital - Birmingham

Birmingham, England, United Kingdom

Site Status

Royal Blackburn Hospital

Blackburn, England, United Kingdom

Site Status

Pilgrim Hospital

Boston, England, United Kingdom

Site Status

Bradford Teaching Hospitals NHS Trust, St Luke's Hospital

Bradford, England, United Kingdom

Site Status

Burnley General Hospital

Burnley, England, United Kingdom

Site Status

Cumberland Infirmary

Carlisle, England, United Kingdom

Site Status

Chelmsford and Essex Centre

Chelmsford, England, United Kingdom

Site Status

Countess of Chester Hospital

Chester, England, United Kingdom

Site Status

Chesterfield Royal Hospital

Chesterfield, England, United Kingdom

Site Status

Essex County Hospital

Colchester, England, United Kingdom

Site Status

Doncaster Royal Infirmary

Doncaster, England, United Kingdom

Site Status

Russells Hall Hospital

Dudley, England, United Kingdom

Site Status

Wycombe General Hospital

High Wycombe, England, United Kingdom

Site Status

Airedale General Hospital

Keighley, England, United Kingdom

Site Status