Phase
Condition
Breast Cancer
Cancer
Treatment
N/AClinical Study ID
Ages 18-70 Female
Study Summary
Eligibility Criteria
Inclusion
DISEASE CHARACTERISTICS:
Histologically proven primary invasive breast cancer that is thought to be suitable for neoadjuvant treatment
No cytological proof of malignancy only
T2 tumor or greater (≥ 20 mm by ultrasound) or any T stage with nodal disease ≥ 20 mm diameter on ultrasound assessment
No evidence of distant metastatic disease as disclosed by bone scan, liver, and chest imaging
Definite indication for neoadjuvant and adjuvant chemotherapy
Primary tumor amenable to biopsy
No inoperable disease that is judged very unlikely to be rendered operable by neoadjuvant treatment
No inflammatory breast cancer
No bilateral invasive breast cancer
HER-2 positivity is NOT an exclusion criterion in the feasibility (pilot) study
Estrogen receptor (ER) positive tumor
No ER-poor disease as defined locally (e.g., H-score < 100, Allred 3/4/5)
Allred 6/7/8, H-score H ≥100 allowed
PATIENT CHARACTERISTICS:
Postmenopausal, meeting 1 of the following criteria:
Over 12 months since last menstrual period
Postmenopausal gonadotrophin levels (luteinizing hormone or follicle-stimulating hormone levels above local criteria)
Postmenopausal estradiol levels below local criteria
Prior bilateral oophorectomy
Menopause induced by gonadotrophin-releasing hormone not allowed
WHO performance status 0 or 1
WBC ≥ 3.0 × 10^9/L
ANC ≥ 1.5 × 10^9/L
Platelets ≥ 100 × 10^9/L
Hemoglobin > 9 g/dL
AST/ALT ≤ 1.5 times upper limit of normal (ULN)
Serum bilirubin ≤ 1.5 times ULN
Alkaline phosphatase ≤ 1.5 times ULN
Serum creatinine ≤ 1.5 times ULN
No active, uncontrolled infection
No malignancy within the past 10 years except for basal cell carcinoma or cervical carcinoma in situ
Treatment for previous malignancy confined to resection alone
No concomitant medical, psychiatric, or geographic problems that might prevent completion of treatment or follow-up
No known severe hypersensitivity to aromatase inhibitors
No contraindication to receiving aromatase inhibitors (clinical evidence or recorded history of osteoporosis)
No other serious illness or medical condition including any of the following:
Congestive heart failure or unstable angina pectoris
Myocardial infarction within the past year
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 peptic ulcer
Unstable diabetes mellitus
No definite contraindications for the use of corticosteroids
No contraindication to receiving combination anthracycline/taxane chemotherapy
Willing to undergo repeat biopsies
PRIOR CONCURRENT THERAPY:
No hormone replacement therapy within 4 weeks of starting treatment
No chronic oral treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent)
No concurrent warfarin or heparin therapy
Study Design
Study Description
Connect with a study center
Asan Medical Center - University of Ulsan College of Medicine
Seoul, 138-736
Korea, Republic ofSite Not Available
West Middlesex University Hospital
Isleworth, England TW7 6AF
United KingdomSite Not Available
Charing Cross Hospital
London, England W6 8RF
United KingdomSite Not Available
Guy's Hospital
London, England SE1 9RT
United KingdomSite Not Available
St. Mary's Hospital
London, England W2 1NY
United KingdomSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.