|
Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer Clinical research trials and Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer health trials happen in many of localities throughout the U.S.. 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 drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer. Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer clinical trial. Human subjects often get the best healthcare available for their Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "N" Clinical Trials Conditions > Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer  Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
For Condition: stage 3B breast cancer,stage 2 breast cancer,stage 3A breast cancer,stage 1 breast cancer,stage 4 breast cancer,stage 3C breast cancer
Status: Recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed. PURPOSE: Phase II trial to study the effectiveness of neoadjuvant docetaxel in treating women who are undergoing surgery for breast cancer.
Details: OBJECTIVES: Primary - Correlate baseline and change in apoptosis and proliferation with clinical and pathological response to neoadjuvant docetaxel followed by surgery in women with newly diagnosed breast cancer. Secondary - Correlate baseline and change in fludeoxyglucose F 18 positron emission tomography uptake with clinical and pathological response in patients treated with this regimen. - Correlate baseline and change in gene expression profiles with clinical and pathological response in patients treated with this regimen. - Correlate baseline and change in tumor and serum proteomic patterns with clinical and pathological response in patients treated with this regimen. OUTLINE: This is a pilot study. - Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 2-8. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. - Surgery: Within 2-4 weeks after the completion of 4 courses of docetaxel, patients undergo breast-conserving surgery or a mastectomy at the discretion of the treating surgeon. - Adjuvant chemotherapy: Patients receive adjuvant chemotherapy at the discretion of the treating physician. - Radiotherapy: Patients undergo radiotherapy after the completion of all chemotherapy at the discretion of the treating physician. - Hormonal therapy: Patients with estrogen- and/or progesterone-positive tumors receive hormonal therapy after the completion of chemotherapy and all local therapies at the discretion of the treating physician. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed infiltrating carcinoma of the breast - Unresected clinical stage T1c, T2, T3, or T4 lesion, any N - Newly diagnosed disease - Diagnostic mammogram and an ultrasound of the affected breast within 3 months before study entry - Mammogram of the contralateral breast within 6 months before study entry - Clinically measurable disease - Hormone receptor status: - Immunohistochemical staining for estrogen and progesterone and HER2/neu receptors must be obtained on initial diagnostic material PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - At least 5 years Hematopoietic - WBC at least 3,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times normal Renal - Creatinine no greater than 1.5 times normal Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No medical condition that would put the patient at unnecessary risk of potentially serious complications during study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for current breast cancer Endocrine therapy - At least 1 month since prior tamoxifen or raloxifene for breast cancer prevention - No prior endocrine therapy for current breast cancer Radiotherapy - No prior radiotherapy for current breast cancer Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
VeredStearns, Principal Investigator, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-1000
United States
Recruiting Vered Stearns 410-955-7955
Additional Information:
Study ID Numbers: CDR0000346460; JHOC-03012301,JHOC-J0266
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080626
Other Stage 2 Breast Cancer Studies:
1. Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
2. Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer
3. Adjuvant High-Dose, Sequential Chemotherapy in Treating Patients With Resected Breast Cancer
4. Chemotherapy Plus Surgery in Treating Women With Breast Cancer
5. Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
Related Studies:
Other stage 2 breast cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
|
|
|
|
|
|
|
|
