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Novartis Clinical
Trials provides information about research studies recruiting
within the U.S. Visit ClinicalTrials.gov, a registry of federally and privately supported clinical trial for more information regarding clinical trials outside of the U.S. |
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Find a Clinical Trial
Breast Cancer
Among cancer deaths in US women, those due to breast cancer are second only to those of lung cancer. Age is a factor - 80% of breast cancers occur in women over 50. In younger women, genetic factors may play a role. Because growth of breast tissue is highly sensitive to estrogens, the more a woman is exposed to estrogen over her lifetime, the higher the risk for breast cancer.
Novartis is seeking people to participate in a clinical trial(s) testing the safety and effectiveness of Novartis products. Novartis recommends that you consult your doctor before participating in a clinical trial. For more information about clinical trial participation, click here. Also, for additional information about how Novartis helps to protect the privacy of the personal information that you provide to us, please see the Novartis Privacy Policy. Please review the details of the clinical trial(s) listed below and click on the one that you feel best suits your (or the participant's) condition.
Breast Cancer Study CZOL446E2352
Novartis Oncology is conducting a study to find out if zoledronic acid is safe and effective for women who have been taking zoledronic acid for the past year and have breast cancer that has spread to the bone. The reason for this study is to find out whether zoledronic acid continues to decrease skeletal-related events (like breaking bones) after a minimum of 9 doses during the previous 10 to 15 months. If it does continue to decrease them, then the study will examine which dose is better between treatment once a month or once every three months. If you agree to join this study you will be assigned randomly to one of two treatment groups of Zometa every 4 weeks or Zometa every 12 weeks . The study drug will be given to participants by intravenous infusion. Zoledronic acid is currently approved in the United States for cancer participants with Hypercalcemia of Malignancy (high calcium in the blood from cancer) and for treatment of cancer participants with multiple myeloma (a blood cancer). Zoledronic acid has also been approved for participants with confirmed bone mestastases (cancer that has spread to the bone) from other solid tumors (like breast cancer) to prevent skeletal related events. The FDA approval in the United States for participants with bone metastases is for zoledronic acid to be used for 12 months. This study will also look at how safe zoledronic acid is after one year.
Trial phase: Phase 3 Participation Duration: 15 visits to the study center over the 13 months, and the visits should last about 2 hours. Protocol Number: CZOL446E2352 HER2-positive Metastatic Breast Cancer Study CLBH589C2204
The purpose of this clinical trial is to find out if the study drug LBH589 is safe and has beneficial effects when in given in combination with trastuzumab (Herceptin®) in people who have HER2-positive Metastatic Breast Cancer who are no longer responding to the trastuzumab (Herceptin®) treatment or other treatments they have already been given. An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Trial phase: Phase 2 Participation Duration: Participants will be asked to visit the study doctor’s office or clinic from 1 to 4 times every week for the first two months. Participants will only be asked to come to the doctor’s office once a week starting with the third month of the study. Each visit should take about 1-3 hours; however, on some days participants will be in the office for approximately 8 hours. Protocol Number: CLBH589C2204
Breast Cancer Study CRAD001J2101
The purpose of this clinical research study is to determine the feasibility of the investigational drug RAD001 when given with the anti-cancer agents, trastuzumab (Herceptin®) and paclitaxel (Taxol®) in patients with HER2-positive metastatic breast cancer.
An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).”
Trial phase: Phase 2 Participation Duration: Participants must pass an initial screening to determine their current health status. After passing the initial screening, participants choosing to enroll in the study will receive the investigational drug RAD001 on a daily basis along with trastuzumab (Herceptin®) and paclitaxel (Taxol®). Participants are expected to return to the hospital clinic weekly for regular blood testing. Trial duration will be approximately 24 weeks. Protocol Number: CRAD001J2101-2 Breast Cancer Study CZOL446E2105
The purpose of this research study is to investigate the repeat-dose pharmacokinetics (PK) profile of zoledronic acid (Zometa®) when administered either once every 4 weeks or once every 12 weeks, in multiple myeloma or breast cancer patients that have already been treated with between 9 to 20 infusions of zoledronic acid (Zometa®) during the previous 10 to 15 months.
Trial phase: Phase 1 Participation Duration: Participants will be asked to visit the study center 18 times over a 1 year period. Protocol Number: CZOL446E2105 |