With extra touches of pink everywhere, from supermarket packaging to sneakers in the NFL, it is easy to see that October is Breast Cancer Awareness Month. For the millions of Americans affected by breast cancer, there is reason to hope: as clinical trials bring about new drugs and new treatments for breast cancer, survival rates have steadily improve over the past 25 years. Today, 85% of women diagnosed with breast cancer are cured, said Lajos Pusztai, MD, DPhil, Chief of Breast Medical Oncology at Yale Cancer Center. “This is a great improvement, but we won’t rest until we get to 100%.”
Breast cancer, Dr. Pusztai noted, is not one, but several kinds of cancers. The most important subtypes include HER2 positve (HER2+), estrogen-receptor/progesterone-receptor positive (ER+/PR+), and triple-negative breast cancers. All of them are treated differently, and all are the subjects of clinical trials at the Breast Center at Smilow Cancer Hospital. Currently, there are 18 open clinical trials that test novel drugs or new combinations of therapies for breast cancer, with a further 10 to open in the next several months.
Pioneering New Treatment Strategies
Compliance with years of anti-estrogen therapy is often challenging for patients. In the Beta Study, patients with early-stage, ER+ cancer who are on anti-estrogen drugs use a two-way, interactive, text messaging application developed at Yale, in collaboration with CircleLink Health, to help communicate to their care team the problems they face in following their medication regimen. Once such issues as side effects, financial concerns, or forgetfulness are identified, care teams assist patients with strategies to address them. Investigators hope this approach will improve the medications’ effectiveness.
For early stage HER2+ cancers, a Yale trial combines all known, effective drugs into a safe regimen that, taken before surgery, may completely eradicate the cancer from the breast. The goal of the study is to achieve such complete eradication of the cancer in over 70% of cases, which translates to excellent long term survival for these patients. For those who do not achieve this great response to therapy and therefore have a poorer prognosis, researchers have a second trial option, which tests the efficacy of a recently introduced new drug called T-DM1 (KadcylaTM).
One of the most exciting recent advances in oncology was the discovery of a new class of drugs called “immune checkpoint inhibitors”, which are antibodies that help stimulate a person’s own immune system. These drugs have shown remarkable improvements in the treatment of metastatic melanoma, lung cancer, bladder cancer and more recently in metastatic triple negative breast cancer. Several of these immune checkpoint studies will open at Yale during the coming months. Yale will be among the first hospitals in the country to test the effectiveness of these drugs in early stage triple-negative breast cancer. Another new trial is opening, that, like the HER2+ trial, takes place pre-surgery. The trial combines the best current standard of care, chemotherapy, with an immune stimulant drug, in the hopes of completely eradicating the cancer.
An additional important research direction is personalized medicine, which aims to identify molecular defects in a cancer and target these with novel drugs. The Breast Cancer Molecular Analysis Prior to Investigation Therapy (MAP-IT) trial uses gene sequencing to look for abnormalities in a patient’s cancer that could be treated with existing targeted therapies or investigational drugs available through the Phase I clinical trial group at Yale Cancer Center.
Participating in a clinical trial means that “a patient may have a chance to receive the treatment of the future today,” Dr. Pusztai said. “All the advances we have made in treating and curing breast cancer are because of new therapies, better tests, and improved screening strategies which are the results of past research. Patients who participated in clinical trials with effective new drugs received the treatments years before these became broadly available for all patients as routine therapy.” However, Dr. Pusztai also cautioned that clinical trials represent research; not all experimental drugs turn out to be effective and unexpected side effects can also be encountered.
For a complete information on all trials currently enrolling patients at the Yale Breast Center visit: https://medicine.yale.edu/lab/pusztai/copy_of_clinicaltrials/copy_2_of_index.aspx