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Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer Clinical research trials and Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer. Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer clinical trial. Human subjects often get the best healthcare possible for their Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer  Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer
Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer
For Condition: stage 2 breast cancer,bone metastases,stage 3A breast cancer,stage 3B breast cancer,stage 3C breast cancer
Status: Recruiting
Sponsor(s): The University of Sheffield ,
Synopsis: RATIONALE: Zoledronate may delay or prevent the formation of bone metastases. It is not yet known whether chemotherapy and/or hormone therapy are more effective with or without zoledronate in preventing cancer recurrence and bone metastases in women who have breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of adjuvant chemotherapy and/or hormone therapy with or without zoledronate in preventing cancer recurrence and bone metastases in women who have stage II or stage III breast cancer.
Details: OBJECTIVES: Primary - Compare disease-free survival of women with stage II or III breast cancer at high risk of relapse treated with adjuvant chemotherapy and/or hormonal therapy with or without zoledronate. Secondary - Compare time to bone metastases, as first recurrence, in patients treated with these regimens. - Compare time to bone metastases, per se, in patients treated with these regimens. - Compare time to distant metastases in patients treated with these regimens. - Compare overall survival in patients treated with these regimens. - Compare the reduction in skeletal-related events (fractures, spinal cord compression, radiotherapy to the bone, surgery to the bone, and hypercalcemia) before and after the development of bone metastases in patients treated with these regimens. - Determine the safety and toxicity of zoledronate in patients treated with these regimens. - Correlate prognostic factors, such as estrogen-receptor and progesterone-receptor status, TNM stage, tumor grade, HER2/neu status, and menopausal status with treatment outcome in patients treated with these regimens. - Determine more specific prognostic indicators for the development of bone metastases and factors that are able to predict specific benefit from bisphosphonate treatment using proteomics, tissue micro-array, and other modern techniques in these patients. OUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive adjuvant chemotherapy and/or hormonal therapy. Patients also receive concurrent zoledronate IV over 15 minutes every 3-4 weeks for 6 doses, every 3 months for 8 doses, and then every 6 months for 5 doses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive adjuvant chemotherapy and/or hormonal therapy alone. Patients are followed annually for 5 years. PROJECTED ACCRUAL: A total of 3,300 patients (1,650 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of primary breast cancer, meeting 1 of the following staging criteria: - Stage II - Evidence of lymph node involvement - Must have undergone prior complete primary tumor resection and treatment of the axillary lymph nodes within the past 60 days - Stage III - Tumor greater than 5 cm OR features of locally advanced disease (T4) - Planning to receive neoadjuvant chemotherapy/endocrine therapy OR have undergone prior complete primary tumor resection and treatment of the axillary lymph nodes - No more than 60 days since prior definitive surgery - No more than 30 days between initiation of neoadjuvant chemotherapy/endocrine therapy and commencement of study drug in non-operative patients - No more than 6 months between initiation of neoadjuvant chemotherapy/endocrine therapy and definitive surgery/radiotherapy - No evidence of recurrent or metastatic disease - No prior breast cancer - Suitable candidate for definitive local therapy - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - Karnofsky 60-100% OR - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Creatinine no greater than 1.5 times upper limit of normal Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other malignancy within the past 5 years (including prior contralateral breast cancer) except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix - No history of disease with influence on bone metabolism, including any of the following: - Paget’s disease of the bone - Primary hyperparathyroidism - Osteoporosis requiring treatment or likely to require treatment within the next 6 months - No other concurrent severe physical or psychological disease that would preclude study compliance - No known hypersensitivity to bisphosphonates PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - See Disease Characteristics Radiotherapy - See Disease Characteristics Surgery - See Disease Characteristics Other - More than 1 year since prior bisphosphonates - More than 30 days since prior investigational drugs - No concurrent investigational drugs (i.e., not locally approved for any indication)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertColeman, , Weston Park Hospital
South Tyneside District Hospital *Recruiting*
South Shields, England, NE34 0PL
United Kingdom
Recruiting J. Bozzino 44-191-219-4200
Southend NHS Trust Hospital *Recruiting*
Westcliff-On-Sea, England, SS0 0RY
United Kingdom
Recruiting Anne Robinson 44-1702-221-226
Clatterbridge Centre for Oncology NHS Trust *Recruiting*
Merseyside, England, CH63 4JY
United Kingdom
Recruiting Susan O'Reilly 44-151-334-1155
Glan Clywd District General Hospital *Recruiting*
Rhyl, Denbighshire, Wales, LL 18 5UJ
United Kingdom
Recruiting Jill Bishop 44-1745-445-154
North Tyneside Hospital *Recruiting*
North Shields, England, NE29 8NH
United Kingdom
Recruiting Tony Branson 44-191-259-6660
Weston Park Hospital *Recruiting*
Sheffield, England, S1O 2SJ
United Kingdom
Recruiting Robert Coleman 44-114-226-5213
Cookridge Hospital at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS16 6QB
United Kingdom
Recruiting D. Dodwell 44-113-392-6788
Additional Information:
Study ID Numbers: CDR0000335111; ISRCTN-79831382,EU-20315,SHEFF-AZURE
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072020
Other Stage 3c Breast Cancer Studies:
1. Combination Chemotherapy Followed by Radiation Therapy With or Without Surgery in Treating Women With Locally Advanced or Inflammatory Breast Cancer
2. Comparison of Three Combination Chemotherapy Regimens in Treating Women With Stage I or Stage II Breast Cancer
3. Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer
4. Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer
5. Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer
Related Studies:
Other stage 3C breast cancer Clinical Trials
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Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer
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