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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 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on 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 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like 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. 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 Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Participants frequently obtain the most expert healthcare available for their 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 condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: intraductal breast carcinoma,breast cancer in situ
Status: Recruiting
Sponsor(s): National Cancer Research Institute (NCRI) ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy after surgery is effective in preventing a recurrence of ductal carcinoma in situ. PURPOSE: Randomizedphase II trial to compare the effectiveness of adjuvant radiation therapy with that of observation after surgery in treating women who have estrogen receptor positive or progesterone receptor positive ductal carcinoma in situ and are also receiving either tamoxifen or anastrozole.
Details: OBJECTIVES: Primary - Compare ipsilateral tumor relapse and breast cancer metastases in women with completely excised low-risk estrogen receptor- or progesterone receptor-positive ductal carcinoma in situ of the breast receiving adjuvant tamoxifen or anastrozole and treated with adjuvant radiotherapy vs observation alone. - Compare the quality of life of patients treated with these regimens. Secondary - Determine the minimal surgical margins required to minimize the local recurrence rate in patients treated with these regimens. - Identify molecular markers that predict ipsilateral tumor recurrence in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. All patients receive adjuvant tamoxifen or anastrozole for 5 years. - Arm I: Patients undergo radiotherapy 5 days a week for 3 or 5 weeks. - Arm II: Patients undergo observation alone. Quality of life is assessed at baseline, at 6 months, and then at 1, 2, and 5 years. Patients are followed every 6 months for 1 year and then annually for up to 10 years. PROJECTED ACCRUAL: A total of 2,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 50 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of unifocal ductal carcinoma in situ of the breast without an invasive component - Microinvasion (defined as 1 or more foci of invasion each < 1 mm) allowed - Prior complete microscopic excision (within the past 6 months) with a minimum radial margin of 1 mm required - Maximum microscopic tumor diameter < 30 mm (< 15 mm if grade 3 tumor) - Planning to receive adjuvant tamoxifen or anastrozole for 5 years - Eligible patients may receive adjuvant endocrine therapy on ICR-IBIS-II - Hormone receptor status: - Estrogen receptor positive OR - Progesterone receptor positive - More than 10% tumor staining for receptor OR a cutpoint of 2 PATIENT CHARACTERISTICS: Age - 50 to 75 Sex - Female Menopausal status - Premenopausal, perimenopausal, or postmenopausal Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No prior deep vein thrombosis Pulmonary - No prior pulmonary embolus Other - No unexplained postmenopausal bleeding - No contraindication to full-dose radiotherapy to the breast - No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - See Disease Characteristics - No prior tamoxifen or raloxifene use for more than 3 months in duration Radiotherapy - Not specified Surgery - See Disease Characteristics - No prior mastectomy Other - No concurrent anticoagulants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JudithBliss, , National Cancer Research Institute (NCRI)
Ninewells Hospital and Medical School *Recruiting*
Dundee, Scotland, DD1 9SY
United Kingdom
Recruiting J.A. Dewar 44-1382-660-111
University of Glasgow *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting W.D. George 44-141-211-2166
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting John Yarnold 44-20-8661-3388
Institute of Cancer Research - UK *Recruiting*
Sutton, England, SM2 5NG
United Kingdom
Recruiting Judith Bliss 44-208-722-4297
South Manchester University Hospital *Recruiting*
Manchester, England, M23 9LT
United Kingdom
Recruiting Nigel Bundred 44-161-291-5859
Additional Information:
Study ID Numbers: CDR0000349580; ICR-DCIS-II,EU-20341
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077168
Other Breast Cancer In Situ Studies:
1. Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
2. Anastrozole Compared With Tamoxifen After Lumpectomy in Treating Postmenopausal Women With Ductal Carcinoma in Situ
3. Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive 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
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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
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