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Home > "A" Clinical Trials Conditions > Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ  Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
For Condition: breast cancer in situ,intraductal breast carcinoma
Status: Recruiting
Sponsor(s): Cancer Research UK ,
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the uptake of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ. PURPOSE: Randomizedphase III trial to compare the effectiveness of adjuvant tamoxifen with that of anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ.
Details: OBJECTIVES: Primary - Compare the efficacy of adjuvant tamoxifen vs anastrozole, in terms of local control and prevention of contralateral disease, in postmenopausal women with locally excised ductal carcinoma in situ. - Compare side effect profiles of these drugs in these patients. Secondary - Compare the efficacy of these drugs, according to the receptor status of the primary or recurrent cancer in these patients. - Compare the rate of breast cancer recurrence and growth of new contralateral tumors after cessation of treatment with these drugs in these patients. - Compare breast cancer mortality in patients treated with these drugs. - Compare the effect of these drugs on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these patients. - Compare the tolerability and acceptability of side effects experienced by patients treated with these drugs. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral tamoxifen and oral placebo once daily. - Arm II: Patients receive oral anastrozole and oral placebo once daily. In both arms, treatment continues for 5 years in the absence of disease recurrence or unacceptable toxicity. Patients are followed annually for 5 years. PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 40 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of ductal carcinoma in situ within the past 6 months - Locally excised with tumor-free margins at least 1 mm - Hormone receptor status: - Estrogen or progesterone receptor positive - Greater than 5% positive cells PATIENT CHARACTERISTICS: Age - 40 to 70 Sex - Female Menopausal status - Postmenopausal, defined as meeting at least 1 of the following criteria: - Over age 60 - Prior bilateral oophorectomy - Age 60 or under with a uterus AND amenorrhea for at least the past 12 months - Age 60 or under without a uterus AND follicle-stimulating hormone greater than 20 IU/L Performance status - Not specified Life expectancy - At least 10 years Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No prior deep vein thrombosis - No prior transient ischemic attack - No prior cerebrovascular accident Pulmonary - No prior pulmonary embolism Other - No unexplained postmenopausal bleeding - No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No other concurrent medical condition that would preclude study therapy, place the patient at unusual risk, or confound study results - No evidence of osteoporosis - Fragility fractures within the spine allowed if T-score level is greater than -4 and consist of no more than 2 fractures - Psychologically and physically suitable for 5 years of study therapy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - No prior or concurrent tamoxifen use lasting more than 3 months - No prior or concurrent raloxifene use lasting more than 3 months - No other prior or concurrent selective estrogen-receptor modulator use lasting more than 3 months - No concurrent systemic estrogen-based hormone replacement therapy, including vaginal estrogen preparations Radiotherapy - Not specified Surgery - See Disease Characteristics - No prior mastectomy - No planned prophylactic mastectomy Other - No prior participation in the International Breast Cancer Intervention Study - At least 3 months since prior unapproved or experimental agents - No concurrent anticoagulants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JackCuzick, , Cancer Research UK
Newcastle Upon Tyne Hospitals NHS Trust *Recruiting*
Newcastle upon Tyne, England, NE1 4LP
United Kingdom
Recruiting Tom Lennard 44-191-232-5131
Western Infirmary *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting David George 44-141-211-2000
Royal Liverpool University Hospital *Recruiting*
Liverpool, England, L69 3GA
United Kingdom
Recruiting Chris Holcombe 44-151-706-4028
Guy's and St. Thomas' Hospitals NHS Trust *Recruiting*
London, England, SE1 9RT
United Kingdom
Recruiting Hisham Hamed 44-171-922-8009
Ninewells Hospital and Medical School *Recruiting*
Dundee, Scotland, DD1 9SY
United Kingdom
Recruiting Alistair Thompson 44-1382-660-111
Frenchay Hospital *Recruiting*
Bristol, England, BS16 1LE
United Kingdom
Recruiting Simon Cawthorn 44-117-970-1212
Christie Hospital N.H.S. Trust *Recruiting*
Manchester, England, M20 4BX
United Kingdom
Recruiting Anthony Howell 44-161-446-8037
University of Wales College of Medicine *Recruiting*
Cardiff, Wales, CF14 4XN
United Kingdom
Recruiting Robert Mansel 44-292-0742-749
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Mark Lansdown 44-113-243-3144
Broomfield Hospital *Recruiting*
Chelmsford, Essex, England, CM1 5ET
United Kingdom
Recruiting Paul Sauven 44-012-454-0761
Belfast City Hospital Trust *Recruiting*
Belfast, Northern Ireland, BT8 8JR
United Kingdom
Recruiting Alan Wilkinson 44-028-9032-9241
Colchester General Hospital *Recruiting*
Colchester, England,
United Kingdom
Recruiting Fiona Macneill 44-012-0674-7474
City Hospital - Birmingham *Recruiting*
Birmingham, England, B18 7QH
United Kingdom
Recruiting Jenny Williamson 44-012-1554-3801
Cancer Research UK *Recruiting*
London, England, WC2A 3PX
United Kingdom
Recruiting Jack Cuzick 44-20-7269-3006
Royal South Hants Hospital *Recruiting*
Southampton, England, SO14 0YG
United Kingdom
Recruiting Anneke Lucasson 44-23-8063-4288
Nottingham City Hospital NHS Trust *Recruiting*
Nottingham, England, NG5 1PB
United Kingdom
Recruiting John Robertson 44-115-969-1169
Whittington Hospital *Recruiting*
London, England, N19 5NF
United Kingdom
Recruiting Richard Sainsbury 44-020-7272-3070
Royal Infirmary of Edinburgh at Little France *Recruiting*
Edinburgh, Scotland, EH3 9YW
United Kingdom
Recruiting Elaine Anderson 44-013-1536-1000
Additional Information:
Study ID Numbers: CDR0000339738; CRUK-IBIS-II-DCIS,EU-20226
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072462
Other Breast Cancer In Situ Studies:
1. Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
2. Adjuvant Radiation Therapy Compared With Observation After Surgery in Treating Women With Estrogen Receptor Positive or Progesterone Receptor Positive Ductal Carcinoma In Situ of the Breast Who Are Receiving Tamoxifen or Anastrozole
3. Medroxyprogesterone in Treating Women With Breast Cancer
4. Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer Who Are Eligible For Tamoxifen Therapy
5. Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ
Related Studies:
Other breast cancer in situ Clinical Trials
Other Scotland Clinical Trials
Other Edinburgh Clinical Trials
Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
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