The Montefiore-Einstein Center for Cancer Care is a National Cancer Institute–designated cancer center. Our ongoing commitment to research in all areas of breast cancer care places us at the forefront of new technology. We are constantly working to improve the standard of care for patients, studying alternative approaches to treatment and exploring new agents of healing through clinical trials and studies. Our research includes preventing breast cancer and minimizing side effects of existing treatments. We are a leader in testing the efficacy of new drug treatments in patients.
Iodide (I-) is an essential constituent of the thyroid hormones T3 and T4. Under physiological conditions, most ingested dietary I- is accumulated in the thyroid by means of a highly specialized active I- transport mechanism, called the sodium iodide symporter (NIS). The only other tissues known to contain NIS are the salivary glands, stomach, and lactating/late gestational breast tissue. Dr. Nancy Carrasco and her colleagues at the Albert Einstein College of Medicine were the first group to isolate, clone, and characterize NIS, and have recently reported that NIS is present in about 80% of human breast cancer (Nature Medicine, 2000). Dr. Carrasco is collaborating with Dr. Sparano and investigators from many other disciplines to determine whether radioactive iodine (131 I), a treatment that has been known to be safe and effective for the treatment of thyroid cancer, can also be used to treat metastatic breast cancer. This is a truly multidisciplinary effort involving investigators from Montefiore (Nuclear Medicine, Pathology, Endocrinology) and Einstein (Molecular Pharmacology, Biostatistics).
Women with metastatic breast cancer who have not responded to conventional therapy are eligible for the study. In the screening phase, the patients' tumor tissue will be evaluated for the presence of NIS by immunohistochemistry, and the patient will undergo a technetium 99 pertechnetate scan and 123 I scan. If the tumor is shown to express NIS, or if tumor uptake is demonstrated by either the pertechnetate or 123 I scan, they will be eligible to continue onto the treatment phase. In the treatment phase, women will receive thyroid hormones to suppress their thyroid gland, undergo additional scans, and will receive a therapeutic dose of radioactive iodine commonly used to treat thyroid cancer. The Montefiore-Einstein Center for Cancer Care is the only cancer center in the country that is evaluating this new approach to treat breast cancer.
The RAS family of proteins are key intermediates in signal transduction that regulate growth, differentiation, and metastases. A number of orally administered drugs that interfere with the process called "farnesyl transferase inhibitors", or "FTIs", are now being evaluated for the treatment of a variety of cancer types. One in particular called Zarnestra (also called R115777) has been shown to produce clinical benefit in about 25% of patients with refractory breast cancer. Dr. Sparano recently initiated and NCI-sponsored trial that is evaluating the role of Zarnestra in combination with standard chemotherapy in patients with locally advanced and metastatic breast cancer. The trial is also being conducted by the N.Y. Phase II Consortium and scientists from the H. Lee Moffitt Cancer Center in Tampa, Florida.
Several genetic mutations are known to be associated with certain cancer types, but this remains elusive for most cancers. Investigators from the Eastern Cooperative Oncology Group are evaluating whether certain genes are associated with cancer predisposition. The study includes 4000 patients with prostate, lung, breast, and colon cancer and their siblings. The patient and the living sibling must have the same cancer type. They will both be asked to submit a blood specimen.
Tamoxifen is a selective estrogen receptor modulator (SERM) that was recently FDA-approved for reducing breast cancer risk in women at high risk for developing the disease. Problems with the drug include a slight increase in the risk of thromboembolic disease and uterine cancer that may offset the benefit afforded by reducing breast cancer risk. Raloxifene is another SERM that is approved for the treatment and prevention of osteoporosis. The Department of Oncology is participating in a national clinical trial (P-2) that directly compares tamoxifen with raloxifene. Only postmenopausal women who are at elevated risk (by the Gail model) are eligible.
The Department of Oncology is participating in a national clinical trial evaluating the role of a bisphosphonate (clodronate) in preventing breast cancer recurrence (B34). Three other studies have evaluated this drug, two showing possible benefits by reducing the recurrence rate in bone and other sites. Several oral and intravenous bisphosphonates are commercially available and approved to treat hypercalcemia and patients with cancer and skeletal metastases. The B34 trial is designed to provide a definitive answer to this question. Patients with stage I-III breast cancer are eligible. They may receive any chemotherapy regimen that the treating physician feels is appropriate either and/or tamoxifen. They are randomized to receive either clodronate (1600 mg/day) or a placebo) for 3 years. Patients who initiate or continue other bisphosphonates are ineligible.
Cancer Center investigators are evaluating whether Yoga can improve tolerance to adjuvant therapy in women with early stage breast cancer. All women attend standardized classes at the Cancer Center taught by a certified Yoga instructor, and are randomized to practice Yoga either immediately or after a 3-6 month wait period. This research is supported by a grant from the NIH and private foundations.