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Home > "C" Clinical Trials Conditions > Clodronate With or Without Chemotherapy and/or Tamoxifen in Treating Women With Stage I or Stage II Breast Cancer  Clodronate With or Without Chemotherapy and/or Tamoxifen in Treating Women With Stage I or Stage II Breast Cancer
Clodronate With or Without Chemotherapy and/or Tamoxifen in Treating Women With Stage I or Stage II Breast Cancer
For Condition: stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): National Surgical Adjuvant Breast and Bowel Project (NSABP) , National Cancer Institute (NCI),Southwest Oncology Group,North Central Cancer Treatment Group
Synopsis: RATIONALE: Clodronate may be effective in preventing the spread of cancer to the bones and other parts of the body. It is not yet known whether clodronate is more effective alone or combined with chemotherapy and /or tamoxifen in preventing metastatic breast cancer. PURPOSE: Randomizedphase III trial to determine the effectiveness of clodronate with or without chemotherapy and /or tamoxifen in preventing metastases in women who have stage I or stage II breast cancer.
Details: OBJECTIVES: - Determine whether clodronate administered alone or in addition to adjuvant chemotherapy and/or tamoxifen improves disease-free survival in women with early stage breast cancer. - Determine whether clodronate reduces the incidence of skeletal metastases and non-skeletal metastases in these patients. - Determine whether clodronate improves overall and relapse-free survival in these patients. - Determine whether clodronate reduces the incidence of skeletal morbidity (e.g., skeletal fractures, hypercalcemia, skeletal pain, need for radiotherapy, spinal cord compression) in these patients. - Investigate the relevance of serum markers of bone turnover as a prognostic factor for the development of bone metastasis in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified by age (under 50 vs 50 and over), number of positive lymph nodes (0 vs 1-3 vs 4 or more), and hormone receptor status (estrogen receptor [ER] and progesterone receptor [PR] negative vs ER and/or PR positive). Patients are randomized to one of two treatment arms. - Arm I: Patients receive oral clodronate daily. - Arm II: Patients receive oral placebo daily. Patients in both arms commence treatment within 2 weeks of randomization and continue treatment for 3 years in the absence of bone metastasis or unacceptable toxicity. Study medication must be continued in the case of documented visceral or soft tissue metastasis or other event without skeletal metastasis. Patients in both arms may also receive adjuvant chemotherapy and/or tamoxifen at the discretion of the protocol investigator. Patients receiving tamoxifen begin tamoxifen therapy within 3-12 weeks after the last dose of chemotherapy. Patients who have undergone a prior lumpectomy receive adjuvant whole breast radiotherapy. Patients who have undergone a prior mastectomy may receive radiotherapy at the investigator's discretion. Patients are followed every 6 months for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 3,200 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven invasive adenocarcinoma of the breast - Stage I or II (T1-3, N0-1, M0) - Must have undergone total mastectomy OR lumpectomy with an axillary dissection or sentinel node biopsy - If any sentinel node is proven histologically positive by hematoxylin-eosin stain (H&E) or deemed suspicious by H&E and confirmed positive by immunohistochemistry, axillary dissection is required - No bilateral malignancy or mammographically suspicious mass or abnormality within the contralateral breast unless histologically benign - Lumpectomy patients eligible if the following conditions are met: - Tumor less than 5 cm (tumor 5 cm or greater allowed at discretion of protocol investigator) - Margins of resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ - Additional surgical resections to obtain clear margins allowed even if axillary dissection has been performed - If residual tumor at resected margins after re-excision(s), total mastectomy is required - No diffuse tumors by mammography that would not be considered surgically amenable to lumpectomy - No other clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant unless histologically benign or, if malignant, surgically removed with clear margins - No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude - Tethering or dimpling of skin or nipple inversion allowed and not considered skin infiltration - No ipsilateral lymph nodes fixed to one another or to other structures (cN2 disease) by clinical examination - No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless biopsy evidence of no tumor involvement - No significant nonmalignant bone disease that is likely to interfere with interpretation of bone x-rays - Skeletal pain allowed only if bone scan and/or roentgenological examination fails to disclose metastatic disease - Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy - No prior breast cancer except lobular carcinoma in situ - Hormone receptor status: - Must have an analysis of estrogen receptor (ER) and progesterone receptor (PR) status on the primary tumor before randomization PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Female Menopausal status: - Not specified Performance status: - Zubrod 0-2 Life expectancy: - At least 10 years (excluding diagnosis of breast cancer) Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 (unless due to ethnic or racial variation) - Platelet count at least 100,000/mm^3 Hepatic: - No hepatic disease that would preclude study entry - Bilirubin no greater than upper limit of normal (ULN) - Alkaline phosphatase less than 2.5 times ULN - SGOT less than 1.5 times ULN - Albumin normal Renal: - No renal disease that would preclude study entry - Creatinine normal - Calcium normal Cardiovascular: - No cardiovascular disease that would preclude study entry Other: - No nonmalignant systemic disease that would preclude study entry - No psychiatric or addictive disorders that would preclude informed consent - Not pregnant or nursing - Fertile patients must use effective contraception - No other prior malignancy within the past 5 years except: - Effectively treated squamous cell or basal cell skin cancer - Carcinoma in situ of the cervix treated by surgery only - Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by hormonal therapy and/or surgery - Patients with other malignancy who have been disease free for at least 5 years and are at low risk of recurrence PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy for breast cancer Chemotherapy: - No prior chemotherapy for breast cancer - Concurrent chemotherapy allowed at the discretion of the protocol investigator Endocrine therapy: - No prior hormonal therapy for breast cancer except adjuvant tamoxifen initiated within 4 weeks prior to study - No concurrent sex hormonal therapy (e.g., birth control pills or ovarian hormone replacement therapy) - No concurrent calcitonin - No other concurrent hormonal therapy until time of first breast cancer recurrence or development of second primary cancer except: - Low-dose estrogen vaginal creams or conjugated estrogen ring (Estring) for symptomatic vaginal dryness - Raloxifene or other selective estrogen receptor modulators for prevention of osteoporosis - Adjuvant luteinizing hormone-releasing hormone agonists/antagonists for medical ovarian ablation - No concurrent tamoxifen during study chemotherapy Radiotherapy: - No prior radiotherapy for breast cancer - No other concurrent radiotherapy, including regional node radiotherapy, for patients with node-negative breast cancer Surgery: - See Disease Characteristics - No more than 84 days since last surgery (lumpectomy, mastectomy, sentinel node biopsy, axillary dissection, or re-excision of lumpectomy margins) for breast cancer Other: - No concurrent participation in any other clinical trials of systemic therapy for early stage breast cancer except for the following radiotherapy trials: - NCIC-MA.20 for node-positive patients - SWOG-S9927 for node-positive mastectomy patients - No concurrent alendronate or other bisphosphonates (e.g., pamidronate) until time of osseous metastasis - No concurrent calcitonin for treatment or prevention of osteoporosis
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlexanderPaterson, Study Chair, Tom Baker Cancer Center - Calgary
Harrington Cancer Center *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting James Clarkson 806-359-4673
Fletcher Allen Health Care - University Health Center Campus *Recruiting*
Burlington, Vermont, 05401
United States
Recruiting Steven Grunberg 802-847-8400
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting William Robinson 806-355-9703
Altru Cancer Center *Recruiting*
Grand Forks, North Dakota, 58201
United States
Recruiting Todor Dentchev 701-780-6363
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
Danville Radiation Therapy Center *Recruiting*
Memphis, Tennessee, 38104
United States
Recruiting Mohammad Jahanzeb 901-523-8990
University of Tennessee Cancer Institute *Recruiting*
Memphis, Tennessee, 38103
United States
Recruiting Mohammad Jahanzeb 901-722-0532
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
University of Washington School of Medicine *Recruiting*
Seattle, Washington, 98109
United States
Recruiting Julie Gralow 206-288-7722
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
Additional Information:
Study ID Numbers: CDR0000068426; NCCTG-NSABP-B-34,CTSU,NSABP-B-34,SWOG-NSABP-B-34
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009945
Other Stage 1 Breast Cancer Studies:
1. Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer
2. Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
3. Timing of Menstrual Cycle and Surgery in Treating Premenopausal Women With Stage I, Stage II, or Stage III Breast Cancer
4. Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive Breast Cancer
5. Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other North Dakota Clinical Trials
Other Bismark Clinical Trials
Clodronate With or Without Chemotherapy and/or Tamoxifen in Treating Women With Stage I or Stage II Breast Cancer
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