ISRCTN87408408CompletedNot Applicable
Molecular profiling of post-menopausal women with breast cancer on Neoadjuvant Endocrine Therapy with tamoxifen or exemestane
Cambridge University Hospitals NHS Trust (UK)0 sites100 target enrollmentStarted: January 26, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1. Women with histological diagnosis of primary invasive breast cancer on core biopsy
- •2. Not a candidate for chemotherapy
- •3. Localised or locally advanced breast cancer
- •4. Ultrasound size at least 2 cm:
- •a. unifocal tumour:
- •i. T2 or T3 tumours (radiological size more than 20 mm)
- •ii. T4 tumour of any size with direct extension to either chest wall or skin
- •iii. inflammatory carcinoma with tumour of any size
- •b. other locally advanced disease:
- •i. clinical and radiological involvement of axillary lymph node (radiological diameter more than 20 mm) and primary breast tumour of any diameter
- •ii. where no primary breast tumour was found, the presence of breast cancer in a Lymph Node (LN) must be histopathologically confirmed by LN biopsy (Tru-cut or whole LN)
- •c. multifocal tumour:
- •i. the sum of the tumour diameters must be more than 20 mm (radiological size more than 20 mm)
- •ii. patients with bilateral disease are eligible to enter the trial
- •iii. no previous treatment for breast cancer
- •5. Oestrogen Receptor (ER) positive (Allred score more than or equal to four)
- •6. Palpable and measurable disease in the breast or axilla
- •7. Post-menopausal defined by following criteria: cessation of menstrual periods for at least 1 year or bilateral surgical oophorectomy or Follicular Stimulating Hormone (FSH) and oestradiol in the post-menopausal range
- •8. At least 2 weeks since prior hormone replacement therapy or phyto-oestrogens herbal, alternative, or Over-The Counter (OTC) sex hormone remedies and not on concomitant hormonal therapy with these agents
- •9. Eastern Cooperative Oncology Group (ECOG) performance status zero, one or two
- •10. Randomisation and treatment within 4 weeks of biopsy
- •11. Patient must have adequate bone marrow, hepatic and renal function
- •12. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •13. Written consent for the trial
Exclusion Criteria
- •1. Patient unfit to receive endocrine-based therapy
- •2. Previous history of cancer excluding basal cell carcinoma, cervical carcinoma in-situ, or ductal carcinoma in situ of the breast
- •3. Previous deep vein thrombosis or pulmonary embolism
Investigators
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