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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.

How to use this system:

The purpose of this system is to help connect interested study participants with clinical research centers. The following is a brief outline explaining the main steps involved in using this system. Please note that every step in this process is optional.

1. Select a clinical trial that you feel best suits your (or the      participant's) health condition.
2. Answer the screening questions to see if you (or the      participant) meet the preliminary qualifications for the study.      The answers to these questions are not retained by this      system.
3. Select a study center to contact for additional information      about the clinical trial.
4. Set up an account and agree to the terms of use for this      system.
5.   Submit your information to the study center you selected.
6. The study center may contact you and may ask more      questions about your (or the participant's) eligibility for the      study. The study center may invite you (and the participant if      applicable) to travel to the study center for additional screening      tests. Novartis cannot guarantee that you will be contacted by      the study center.
7. If you are eligible to participate in the study, then you will be      required to sign an informed consent before enrolling in the      study. An informed consent is provided to you to help you      understand the clinical trial, the nature of the medical treatment      (if any), procedures and known risks involved, before you agree      to participate in the study.

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 9-20 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 three treatment groups which includes a treatment discontinuation group where participants will be required to have an infusion that contains no medicine. 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




HER2-positive Breast Cancer Study CRAD001J2101

The purpose of this clinical trial is to determine whether adding the study drug RAD001 to two other anti-cancer agents, trastuzumab and paclitaxel, is safe and has beneficial effect in participants with HER2-positive metastatic breast cancer. The study drug RAD001 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: The study drug will be administered on a daily basis or a weekly basis depending on the treatment group assigned to the participant. Trastuzumab will be given as infusions directly into a vein in 28-day cycles on Day 1, 8, 15 and 22 of each cycle. Paclitaxel will also be given as infusions directly into a vein in 28-day cycles on Day 1, 8, 15 of each cycle. Patients will receive at least 6 cycles of treatment.
Protocol Number: CRAD001J2101






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