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This is the category page. Below are all of the research programs that are associated with it
- Breast Cancer -
CIRG (TRIO) 011/NSABP-B44-I/BO20906: A MULTICENTER PHASE III RANDOMIZED TRIAL OF ADJUVANT THERAPY FOR PATIENTS WITH HER2-POSITIVE NODE-POSITIVE OR HIGH RISK NODE-NEGATIVE BREAST CANCER COMPARING CHEMOTHERAPY PLUS TRASTUZUMAB WITH CHMOTHERAPY PLUS TRASTUZUMAB PLUS BEVACIZUMAB
(1_20080703_118)
Women who meet criteria will be randomly assigned to receive chemotherapy once every three weeks plus trastuzumab for six cycles and continue trastuzumab until one year after the first dose or that same treatment, plus bevacizumab for one year. In addition, participants will receive radiation therapy and hormonal therapy as necessary. Participants will need to allow their original tumor to be retested for the HER2-positive tumor at an outside laboratory. A cycle is equal to 3 weeks. Treatments are planned for 6 cycles. All participants will have a physical examination, including having blood pressure checked and blood tests to check blood counts, liver and kidney function. Between cycles 3 and 4, participants will have an echocardiogram or MUGA scan to check heart function. Participants receiving bevacizumab will need to have a urine test before each cycle to check for protein in their urine. Following completion of the 6 cycles examinations and testing will be repeated, including an annual mammogram.
- Breast Cancer -
ECOG #E5103: A DOUBLE-BLIND PHASE III TRIAL OF DOXORUBICIN AND CYCLOPHOSPHAMIDE FOLLOWED BY PACLITAXEL WITH BEVACIZUMAB OR PLACEBO IN PATIENTS WITH LYMPH NODE POSITIVE AND HIGH RISK LYMPH NODE NEGATIVE BREAST CANCER
(1_20081208_118)
Participants are randomized to one of the following three three treatment groups:
Arm I: Active Comparator -Participant receives doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Participants then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.
Arm II: Experimental - Participants receive doxorubicin hydrochloride and cyclophosphamide as in Arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Participants then receive paclitaxel as in Arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.
Arm III: Experimental - Participants receive doxorubicin hydrochloride and cyclophosphamide as in Arm I and bevacizumab as in Arm II. Treatment repeats every 2 or 3 weeks for 4 courses. Patients then receive paclitaxel as in Arm I and bevacizumab as in Arm II. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Participants then receive open-label bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses.
- Breast Cancer -
NSABP #B-40: A RANDOMIZED PHASE III TRIAL OF NEOADJUVANT THERAPY IN PATIENTS WITH PALPABLE AND OPERABLE BREAST CANCER EVALUATING THE EFFECT ON PATHOLOGIC COMPLETE RESPONSE (PCR) OF ADDING CAPECITABINE OR GEMCITABINE TO DOCETAXEL WHEN ADMINISTERED BEFORE AC WITH OR WITHOUT BEVACIZUMAB AND CORRELATIVE SCIENCE STUDIES ATTEMPTING TO IDENTIFY PREDICTORS OF HIGH LIKELIHOOD FOR PCR WITH EACH OF THE REGIMENS
(1_20070702_118)
Use of FDA approved drugs. Patient will initially receive 1 of 6 docetaxel-based regimens every 3 weeks for 4 cycles. Following neoadjuvant treatment, patients will undergo lumpectomy or mastectomy and axillary staging.
- Breast Cancer -
NSABP #B-41: A RANDOMIZED PHASE III TRIAL OF NEOADJUVANT THERAPY IN PATIENTS WITH PALPABLE AND OPERABLE HER2-POSITIVE BREAST CANCER COMPARING THE COMBINATION OF TRASTUZUMAB PLUS LAPATINIB TO TRASTUZUMAB AND TO LAPATINIB ADMINISTERED WITH WEEKLY PACLITAXEL FOLLOWING AC ACCOMPANIED BY CORRELATIVE SCIENCE STUDIES TO IDENTIFY PREDICTORS OF PATHOLOGIC COMPLETED RESPONSE (2_20070905_118)
This study is designed for women with palpable and operable HER2-positive breast cancer. All patients will receive standard doses of AC every 3 weeks for 4 cycles followed by weekly paclitaxel on Days 1, 8, and 15 every 28 days for 4 cycles. Concurrently with paclitaxel, Group 1 patients will receive trastuzumab weekly until surgery; Group 2 patients will receive lapatinib daily until surgery; and Group 3 patients will receive trastuzumab weekly plus lapatinib daily until surgery. Tumor assessments by physical exam to determine clinical response will be reported between chemotherapy regimens and following the last chemotherapy cycle prior to surgery. Follow completion of neoadjuvant therapy, patients will undergo lumpectomy or mastectomy and axillary staging (choice of procedure will be at the physician’s discretion). All patients will receive postoperative trastuzumab every 3 weeks continuing until 1 year after administration of the first preoperative targeted therapy dose.
- Breast Cancer -
NSABP #B-42: A CLINICAL TRIAL TO DETERMINE THE EFFICACY OF FIVE YEARS OF LETROZOLE COMPARED TO PLACEBO IN PATIENTS COMPLETING FIVE YEARS OF HORMONAL THERAPY CONSISTING OF AN AROMATASE INHIBITOR (AI) OR TAMOXIFEN FOLLOWED BY AN AI IN PROLONGING DISEASE-FREE SURVIVAL IN POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE BREAST CANCER
(2_20070208_118)
This study will use an FDA approved drug, Letrozole and a placebo. Participants will be randomized to take either 2.5 mg of letrozole or placebo. Both will be taken orally one a day for 5 years. It is also recommended that participants take Calcium and Vitamin D supplements.
- Breast Cancer, Metastatic -
NCCTG #N0537: PHASE II TRIAL OF VEGF TRAP IN PATIENTS WITH METASTATIC BREAST CANCER PREVIOUSLY TREATED WITH ANTHRACYCLINE AND/OR TAXANE (2_20070311_118)
Use of an investigational drug given intravenously day 1 for a 14 day cycle. Participants will continue with this cycle until disease progression, intolerable adverse events or patient refusal.
- Breast Cancer, Metastatic -
NCCTG N0735: PHASE II TRIAL OF ALBUMIN-BOUND PACLITAXEL IN COMBINATION WITH GEMCITABINE AND BEVACIZUMAB IN PATIENTS WITH METASTATIC BREAST CANCER
(1_20090301_118)
This is a Phase II study for patients with metastatic breast cancer. This study will use gemcitabine, albumin-bound paclitaxel and bevacizumab, which are already FDA approved drugs, but they are now being studied to use them in a different way. This is a multi-center study. Participants will be assigned to one of three arms. Participants will receive treatments in cycles of 21 days until disease progression; or if the participants experiences and adverse events; or participant no longer wishes to continue in the study.
- Breast Cancer, Metastatic:
CALGB: C70604: A RANDOMIZED, PHASE III STUDY OF STANDARD DOSING VERSUS LONGER DOSING INTERVAL OF ZOLEDRONIC ACID IN METASTATIC CANCER
(2_20090604_118)
This is a study for patients with metastatic breast, prostate or multiple myeloma to bone. There are 2 arms to this study; Arm 1 is considered standard treatment and participants will receive Zoledronic acid IV over 15 minutes. This course will repeat every 4 weeks for up to 2 years or until disease progression or unacceptable side effects. Arm 2 is the considered the experimental treatment; participants will receive Zoledronic acid IV over 15 minutes; course repeats every 12 weeks for up to 2 years if no disease progression or unacceptable side effects. Participants will be instructed to take calcium and Vitamin D daily.
- Breast Cancer, Recurrent or Metastatic -
CALGB: C40502: A RANDOMIZED PHASE III TRIAL OF WEEKLY PACLITAXEL COMPARED TO WEEKLY NANOPARTICLE ALBUMIN BOUND NAB-PACLITAXEL OR IXABEPILONE COMBINED WITH BEVACIZUMAB AS FIRST-LINE THERAPY FOR LOCALLY RECURRENT OR METASTATIC BREAST CANCER
(1_20090403_118)
This is a chemotherapy regimen study. There will be three Arms to the study: Arm A will receive Paclitaxel and Bevacizumab; Arm B will receive Nab-Paclitaxel and Bevacizumab; and Arm C will receive Ixabepilone and Bevacizumab. Chemotherapy is giving in cycles and each cycle is 28 days. Participants will continue on with this treatment until disease progression or unacceptable side effects.
- Breast Cancer:
Study Closed to Accrual:
NCCTG #N0733: RANDOMIZED PHASE II TRIAL OF CAPECITABINE AND LAPATINIB WITH OR WITHOUT IMC-A12 IN PATIENTS WITH HER2 POSITIVE BREAST CANCER PREVIOUSLY TREATED WITH TRASTUZUMAB AND AN ANTHRACYCLINE AND/OR A TAXANE
(2_20090401_118)
This is a Phase II trial for patients with breast cancer using an investigational drug called IMC-A12; and two FDA approved drugs Xeloda (capecitabine) and Tykerb (lapatinib), however, they are being used differently than approved. Participants will be randomized to one of two arms: Arm A will consist of Capecitabine and Lapatinib; and Arm B will consist of Capecitabine, Lapatinib and IMC-A12. Participants will be on cycles consisting of 21 days. Participants will remain on the study until progression of disease; or experience an adverse event; or the participant no longer wishes to participate in the study.
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