Trial of Perioperative Endocrine Therapy - Individualising Care (POETIC)

• Conditions: Post menopausal women with hormone (ER/PgR) receptor positive breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-003877-21-GB
• Lead Sponsor: Institute of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-28
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Hormone receptor positive breast cancer is defined as an Allred score of 3 or more, or a Histoscore of 2 or more, or more than 1% of positive cells for oestrogen receptor or progesterone receptor.

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) aged >50 years 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, 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) and blood samples.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

Exclusion Criteria

1) Locally advanced/inoperable breast cancer
2) Evidence of metastatic disease
3) Previous invasive breast cancer or bilateral breast cancer (surgically treated DCIS or LCIS allowed)
4) Concurrent use (defined as use within 4 weeks prior to baseline tissue sample being taken prior to entry) of HRT or any other oestrogen-containing medication (including vaginal oestrogens)
5) Previous use of oestrogen implants at ANY time
6) Prior endocrine therapy or chemotherapy for breast cancer
7) Any invasive malignancy diagnosed within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ)
8) Any severe co-incident medical disease, inability to give informed consent or unavailability for follow-up
9) Treatment with an unlicensed or investigational drug within 4 weeks before randomisation
10) Continuous long term systemic steroid usage

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified