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Clinical Trials

Breast Protocols

Please check with your physician for additional protocols and/or information.

1.  S1007:  A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes Hormone Receptor Positive and Her2 Negative Breast Cancer with RS of 25 or Less

The purpose of this study is to find out if the Oncotype DX® Recurrence Score can help decide whether patients should receive chemotherapy or not.  This study is being done in patients with lower Recurrence Scores (25 or less).

2.  NSABP-B47:  A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone to Chemo + Trastuzumab (Herceptin) in Women with Node Positive of High Risk Node Negative Her2 Low Invasive Breast Cancer

The main purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin®), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning.

3.  S1202:  A Phase III Study of Duloxetine for AI-associated Musculoskeletal Symptoms for Early Stage Breast Cancer

The purpose of this study is to assess the effects, good and/or bad, of the medication duloxetine compared to placebo (contains no active ingredient) on your joint pain that is associated with taking aromatase inhibitors.  Duloxetine is a drug usually prescribed to treat depression or anxiety, pain caused by nerve damage or fibromyalgia (a painful muscle/bone/nerve disorder) and a muscle and bone pain from a type of arthritis.  Researchers on this study want to see if the pain relieving effects of the drug work for your type of pain. 

S1207:  Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating The Use Of Adjuvant Endocrine Therapy +/- 1 Year Of Everolimus In Patients With High-Risk Hormone Receptor-Positive & HER2/NEU Negative Breast Cancer

The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning.  The current standard treatment after chemotherapy is hormone treatment alone.  Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney or breast cancer. It is considered investigational for non-metastatic breast cancer patients.  In this study you will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer. 

4.  E1Z11:  A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)

This research is being done to find out what effects, good and/or bad, that anastrozole has on you and whether your genes can help explain how anastrozole affects you. Specifically, many women who take anastrozole, or one of the other aromatase inhibitors (letrozole or exemestane) during treatment for breast cancer report muscle and joint aches; however, the reasons that lead to these symptoms are not known. These symptoms have been designated “aromatase inhibitor-associated musculoskeletal syndrome” (or AIMSS). Small studies have suggested that a person’s genetic information may help us to develop a way to predict who will develop side effects and how best to treat them, and we hope to collect information in this study to look at this more closely. In addition, we hope to look at how the side effects from hormone therapy influence quality of life and a patient’s willingness to continue hormonal treatment 

5.  Z11102:  Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers

The purpose of this research study is to determine whether breast conservation surgery, also called lumpectomy, the removal of only the tumor tissues from the breast, is as effective as mastectomy, or the removal of the entire breast, at keeping the cancer from returning. 

6.  A221102:  A Randomized Double Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women with AI Induced Arthralgia

The purpose of this study is to compare the effects, good and/or bad, of the study agent, testosterone, with a placebo (an inactive agent) on joint pain caused by taking aromatase inhibitors.  The testosterone will be mixed with a little anastrozole to prevent any medication from turning into estrogen. The testosterone/placebo is a pellet that is placed just under your skin on the upper buttocks or gluteal region. . In this study, you will receive either the testosterone or placebo.  You will not receive both. 

For more information on these protocols or any other research, please contact your physician or our clinical research coordinator, Jessica Gerlach, CCRP at 845-333-1133.

Orange Regional Medical Center
707 East Main Street
Middletown, NY 10940
845-333-1000

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Orange Regional Medical Pavilion
75 Crystal Run Road
Middletown, NY 10940
845-695-5800

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