A neoadjuvant study of chemotherapy versus endocrine therapy in postmenopausal patients with primary breast cancer - NEOCENT

Phase 1

• Conditions: This trial will involve postmenopausal patients with histologically confirmed breast tumours in whom it is felt cytoreductive systemic therapy would enable conservative surgery to be carried out.; MedDRA version: 13.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2006-003596-12-GB
• Lead Sponsor: Imperial College of Science Technology and Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-20
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Histologically proven primary invasive breast cancer which is thought to be suitable for neoadjuvant treatment • T2 tumour or above (ultrasound size >20mm) or any T stage with nodal disease = 20mm diameter on ultrasound assessment • Tumour must be ER positive (patients with ‘ER poor disease’ as defined locally should be excluded. Eligible patients include Allred 6/7/8, H-score =100. • Postmenopausal up to the age of 70 years of age postmenopausal status as defined by: • >12 months since last menstrual period at time of diagnosis OR • postmenopausal gonadotrophin levels (luteinizing hormone or follicle stimulating hormone levels above local criteria) or postmenopausal estradiol levels below local criteria) OR • prior bilateral oophorectomy • (menopause induced by GnRH (gonadotrophin releasing hormone) is not accepted) • Pre-treatment haematology and biochemistry values within acceptable limits: • Hb > 9g/dL • AST/ALT = 1.5 x Upper limit of normal (ULN) • WBC >3.0 x109/l and ANC > 1.5 x 109/l • Platelets > 100 x 109/l • Serum bilirubin <1.5 UNL • Alkaline phosphatase < 1.5 x UNL • Serum creatinine < 1.5 x UNL • WHO Performance Status 0 or 1 • Definite indication for adjuvant chemotherapy • No active, uncontrolled infection • Primary amenable to biopsy • Written informed consent prior to commencement of specific protocol procedures. • No previous malignancy except in the case of basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease-free for 10 years, and where treatment consisted solely of resection. • No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Inflammatory breast cancer • Inoperable disease that is judged very unlikely to be rendered operable by neoadjuvant treatment • ER poor disease as defined locally (e.g: H-score <100, Allred 3/4/5) • Known severe hypersensitivity to aromatase inhibitors. • Any contra-indication to receiving aromatase inhibitors ie clinical evidence or recorded history of osteoporosis • Bilateral invasive breast cancer. • Other serious illness or medical condition: • congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias • history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent • active uncontrolled infection • active peptic ulcer, unstable diabetes mellitus • HRT within 4 weeks of starting treatment • Definite contraindications for the use of corticosteroids. • Any contra-indication to receiving combination anthracycline/taxane chemotherapy • Evidence of distant metastatic disease as disclosed by bone scan, liver and chest imaging. • Only cytological proof of malignancy • Patients not able or willing to give informed consent • Chronic oral treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (? 20 mg methylprednisolone or equivalent). • Warfarin or Heparin therapy

Study & Design

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