Breast Cancer Clinical Trials

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Breast Cancer Clinical Trials

Clinical Trials Close to Home

Huntington Cancer Center offers adult breast cancer patients significant opportunities to participate in promising new clinical trials that may reduce their risk for cancer – or improve their prognosis once cancer has been diagnosed.

“It is in large part due to past trials that prevention and treatment mechanisms have improved so greatly over recent years.

– Ruth Williamson, MD

Clinical trials are designed to test the benefits of possible new treatments or diagnostic procedures. Large, randomized trials are widely recognized as the best means for testing new methodologies.

Patients taking part in a clinical trial not only have the potential to benefit themselves, they are also advancing research in ways that may help thousands of future patients.

Types of Clinical Trials

  • Phase 1 trials study whether a new treatment is safe over a range of doses, and may include patients with a wide variety of cancers.
  • Phase 2 trials evaluate how well a treatment works in a particular cancer.
  • Phase 3 trials study how well a treatment works compared to other, usually standard, treatments. In Phase 3 trials, patients are selected at random to receive either the experimental or the standard treatment. They may not choose which treatment they will receive.

Current Trials Open to Enrollment

ABSTRACT: Breast cancer related lymphedema affects 3-40% of breast cancer patients. Women with lymphedema report disruptions in their activities of daily living, sexual and social life such as traveling, exercise and leisure activities and overall quality of life. A recent systematic review of the literature for breast cancer related lymphedema demonstrated a lack of studies on which to develop standard prevention guidelines. Studies have shown that over half of breast cancer patients seek out and use complementary alternative medicine (CAM). Acupuncture is one of the most commonly studied CAM modalities, and there is good evidence for its effectiveness in treating cancer treatment-related symptoms. While a few studies have demonstrated the effectiveness of acupuncture in treating lymphedema once it develops, no study has evaluated the use of acupuncture to prevent lymphedema. The current study aims to determine the feasibility and benefits of an integrative therapy program (ITP) intervention utilizing self-management education in conjunction with acupuncture to prevent the development of breast cancer-related lymphedema among high-risk post-operative breast cancer patients.

SPONSOR: Huntington Hospital

For more information, please call Suzie Kline, Ph.D., N.P. at (626) 397-2537 or our Clinical Research department at (626) 397-3877

ABSTRACT: Breast cancer is the most common cancer among women, and surgery remains the mainstay of treatment. The cause is multifactorial, but general anesthesia for breast surgery is associated with postoperative pain, nausea, and vomiting, which can negatively affect the patients’ perioperative experience and prolong the length of the hospital stay. With increasing rates of mastectomy and reconstruction among women with breast cancer or at high risk for breast cancer, and the trend towards outpatient same-day surgery, there is a need for anesthetic techniques which reduce the sedation and nausea/vomiting resulting from general anesthesia and pain medications while optimizing pain control at or around the time of surgery.

First described in 2011, the pectoral block (PB) is an easy and reliable nerve block, which aims to block the pectoral nerves, the intercostobrachial, intercostals III, IV, V, VI, and the long thoracic nerve. Together, blockade of these sensory nerves can provide complete pain relief during breast surgery. The PB has been shown to result in the use of less pain medications and lower rates of nausea and vomiting in women with breast cancer undergoing modified radical mastectomy without reconstruction. However, in the United States, women undergoing mastectomy are increasingly choosing immediate breast reconstruction, and the majority of these patients opt to have placement of a tissue expander or implant under the pectoral muscle. The stretching of the pectoral major muscle can result in significant muscle spasms and pain. Thus, a PB may be particularly helpful for these patients. The current study is a randomized phase 3 clinical trial being conducted to determine the effectiveness of a PB on postoperative pain, nausea, and vomiting, and perioperative pain medication use in women undergoing mastectomy with immediate breast reconstruction with a submuscular tissue expander or implant.

SPONSOR: Huntington Hospital Cancer Program

For more information, please contact Dr. Jeannie Shen at (626) 356-3167 or our Clinical Research Coordinator at (626) 397-3882.

ABSTRACT: Early detection saves lives, and numerous studies have proven the benefits of routine screening mammography. However, approximately 50% of women have what is considered “dense breasts.” Higher breast density reduces the sensitivity of mammography and also increases the likelihood of call-backs. Digital Breast Tomosynthesis (DBT), also known as 3D mammography, is a new FDA-approved technique which has been shown to increase breast cancer detection with fewer call-backs compared to standard full field digital mammography. Breast MRI is the most sensitive breast cancer screening test, and has been shown to detect more breast cancers in women at intermediate to high risk, as well as women at average breast cancer risk. Despite its high diagnostic accuracy, the cost of MRI has been one of the reasons which has precluded its use as a screening test for all women with dense breasts. One alternative is Abbreviated breast MRI (AB-MR), which uses a scan time of less than 10 minutes (compared with 25-40 minutes for standard breast MRI) and reduces its cost. Early studies of AB-MR have shown equivalent sensitivity to full MRI. The current study is being conducted to determine the benefit of AB-MR in addition to DBT in detecting invasive breast cancers. All women with dense breasts who are not considered at intermediate-high risk for breast cancer are eligible.

SPONSOR: Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN)

For more information, please contact Dr. Jon Foran at (626) 793-6141 or our Clinical Research Coordinator at (626) 397-3882.

ABSTRACT: Obesity is a growing health problem in the United States and increasingly, around the world. Excess body weight has been linked to an increased risk of postmenopausal breast cancer and triple negative premenopausal breast cancer. Growing evidence also suggests that obesity is associated with poorer prognosis in women diagnosed with early stage breast cancer. Dozens of studies demonstrate that women who are overweight or obese at the time of breast cancer diagnosis are at increased risk of cancer recurrence and death as compared to leaner women. Observational studies have also demonstrated that women who engage in modest levels of physical activity after breast cancer diagnosis have lower rates of breast cancer recurrence, breast cancer-related death, and overall mortality as compared to inactive women. However, despite the large body of observational data supporting a relationship between weight, exercise and breast cancer prognosis, there is little information regarding the impact of weight loss and increased physical activity upon the risk of recurrence and death in women with early stage breast cancer. The current study aims to compare the effect of a supervised weight loss intervention plus health education materials vs. health education materials alone on breast cancer survival rates in overweight and obese women diagnosed with HER2 negative, stage 2 and 3 breast cancer.

SPONSOR: Alliance for Clinical Trials in Oncology

For more information, please contact Dr. Ruth Williamson at (626) 397-5149 or our Clinical Research Coordinator at (626) 397-3882.

Does Insurance Cover the Cost of Clinical Trials?

While insurance payments may not cover all costs associated with an experimental treatment, most insurance companies will cover the portion of care deemed standard and non-experimental. Many pharmaceutical tests provide the drugs under investigation at no cost to the patient.

Medi-Cal patients: please note this reimbursement mechanism does not cover costs associated with Phase I trials.