Status:
COMPLETED
Chemotherapy or Letrozole Before Surgery in Treating Postmenopausal Women With Breast Cancer That Can Be Removed By Surgery
Lead Sponsor:
Imperial College London
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estrogen can stimulate the growth of brea...
Detailed Description
OBJECTIVES: * To compare the efficacy and tolerability of cytotoxic chemotherapy versus aromatase inhibition for the down-staging of strongly ER+ primary breast cancer in postmenopausal women. * To i...
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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
756 Patients enrolled
Trial Details
Trial ID
NCT00963729
Start Date
September 1 2008
End Date
March 1 2011
Last Update
August 12 2013
Active Locations (5)
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1
Asan Medical Center - University of Ulsan College of Medicine
Seoul, South Korea, 138-736
2
West Middlesex University Hospital
Isleworth, England, United Kingdom, TW7 6AF
3
Guy's Hospital
London, England, United Kingdom, SE1 9RT
4
St. Mary's Hospital
London, England, United Kingdom, W2 1NY