Study record managers: refer to the Data Element Definitions if submitting registration or information. This trial will determine whether the addition of bevacizumab to a regimen of docetaxel and cyclophosphamide TCB improves invasive disease-free survival relative to docetaxel and cyclophosphamide alone TC. A secondary aim will expat women dating in Pennsylvania to determine whether the addition of bevacizumab to TC improves invasive disease-free survival compared to a regimen of docetaxel, doxorubicin, and cyclophosphamide TAC.
Other secondary aims include whether TCB improves disease-free survival, overall survival, and recurrence-free interval relative to TC alone and to Laredo TX online dating profile headlines. The toxicities of the three regimens will also be compared.
Primary prophylaxis with pegfilgrastim or filgrastim is required for Group 1 patients optional for patients in Groups 2 and 3. Patients will also receive adjuvant radiation therapy as clinically indicated and endocrine therapy for hormone receptor-positive tumors. Tumor samples will be submitted for correlative science studies to evaluate predictors of study therapy benefit.
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Last Update Posted : September 10, Study Description. The main japanese girl looking for Pensacola FL boyfriend of this study is to learn if adding bevacizumab to standard treatment with chemotherapy docetaxel, doxorubicin, and cyclophosphamide for early stage HER2-negative breast cancer will prevent breast cancer from returning. A second purpose of this study is to learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative breast cancer live longer.
The researchers also want to learn about the side effects of the combination of drugs used in this study. Detailed Description:. MedlinePlus related topics: Breast Cancer. Drug Information available for: Bevacizumab.
FDA Resources. Arms and Interventions. Outcome Measures.
Eligibility Criteria. Inclusion Criteria: Patients must be female. The patient must be greater than or equal to 18 years of age and less than or equal to 70 years of age. The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination. If pN0, at least one of the following criteria must be met: ER negative and PgR negative; or Pathologic tumor size greater than 2.
Patients must have undergone either a total mastectomy or breast-conserving surgery lumpectomy. For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures must be performed to obtain clear margins.
If tumor is still present at the resected margin after re-excision sthe patient must undergo total mastectomy to be eligible. Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection. For patients who undergo mastectomy, margins must be histologically free of invasive tumor and DCIS. Patients must have completed one of the following nsa Denton TX for evaluation of pathologic nodal status: Sentinel lymphadenectomy alone if pathologic nodal staging based on date in Pueblo CO romantic lymphadenectomy is pN0, pN1mi, or pN1b; Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node SN Huntington positive; or Axillary lymphadenectomy without SN isolation procedure.
The interval between the last surgery for breast cancer treatment or staging and randomization must dating at least 28 days but no more than 84 days. Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed.
The following criteria for evidence of adequate hepatic function must be met based on the of the most recent postoperative tests: total bilirubin must be less than or equal to upper limits of normal ULN for the lab unless the patient has a bilirubin elevation less than ULN to 1. For example, if the alkaline phosphatase is greater than the ULN but less than or equal to 2. Patients with alkaline phosphatase that is greater than ULN but less than or equal i Santa Rosa looking for a nice man 2.
The most recent postoperative serum creatinine must be less than or equal to ULN for the lab.
A urine sample must be tested for proteinuria by the dipstick method. Eligibility must be based on the most recent postoperative test result s performed within 6 weeks prior to randomization. Exclusion Criteria: T4 tumors including inflammatory breast cancer. Definitive clinical or radiologic evidence of metastatic disease. Synchronous or metachronous contralateral invasive breast cancer. Any history of ipsilateral invasive breast cancer or dating Murfreesboro TN friends DCIS.
History of non-breast malignancies within 5 years prior to randomization, except for the following: carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinomas of the skin. therapy with anthracyclines, taxanes, or bevacizumab for any malignancy. Chemotherapy administered date locally Washington Dc the currently diagnosed breast cancer prior to randomization.
Continued therapy with any hormonal agent such as raloxifene or tamoxifen or other SERM or an aromatase inhibitor. Patients are eligible if these medications are discontinued prior to randomization. Any sex hormonal therapy, e.
A clinical trial comparing the combination of tc plus bevacizumab to tc alone and to tac for women with node-positive or high-risk node-negative, her2-negative breast cancer
Active hepatitis B or hepatitis C with abnormal liver function tests. This includes but is not confined to 1 Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis, 2 History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular LV function; history of documented congestive heart failure CHF ; and documented cardiomyopathy.
Uncontrolled hypertension defined as systolic BP greater than mmHg or diastolic BP greater dating pretty Pembroke Pines woman 90 mmHg, with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria. History of hypertensive crisis or hypertensive encephalopathy.
History of any arterial thrombotic event within 12 months prior to randomization. Symptomatic peripheral vascular disease.
Intrinsic lung disease resulting in dyspnea. Unstable diabetes mellitus. Active infection or chronic infection requiring suppressive antibiotics. History of a major organ allograft or condition requiring chronic immunosuppression, e. Patients who have received corneal transplants, cadaver skin, japanese Atlantic dating service bone transplants are eligible.
Any ificant bleeding within days prior to randomization, exclusive of menorrhagia in premenopausal women. Non-healing wound, skin ulcers, or incompletely healed bone fracture. Major surgical procedure, open biopsy, or ificant traumatic injury within 28 days prior to the planned start of study therapy.
Anticipation of need for major surgical procedures during study therapy and fuck dating Ocala FL at least 3 months following completion of bevacizumab. Gastroduodenal ulcer s documented by endoscopy to be active within 6 months before randomization.
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History of GI perforation, abdominal fistulae, or intra-abdominal abscess. Known bleeding diathesis or coagulopathy. Requirement for therapeutic doses of coumadin or equivalent. Conditions that would prohibit administration of corticosteroids.
History of hypersensitivity reaction to drugs formulated with polysorbate Pregnancy or lactation at the time of study entry. Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements. Use of any investigational product within 4 weeks prior to randomization. Contacts and Locations.
Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.
Mary's Regional Cancer Center at Completely free dating in Salinas. More Information. National Library of Medicine U. National Institutes of Health U.
Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.