Cancers grow and divide by exploiting abnormalities in the regulating systems that oversee healthy cell behavior in our bodies. For example, the ERBB2 gene (erb-b2 receptor tyrosine kinase 2) produces HER2 proteins that are receptors on many types of cells, driving the growth of the cell. Normally these receptors help control how healthy cells grow, divide and repair themselves.
In breast cancer, receptors increase in number. This is known as HER2 overexpression or amplification and it causes breast cells to divide and grow in an uncontrolled manner. HER2 overexpression is a major risk factor for cancer.
Approximately 1 in 5 breast cancers are HER2-positive and this type tends to be more aggressive than HER2-negative breast cancer.
A new investigator-initiated clinical trial for people with previously treated advanced (metastatic) HER2-positive breast cancer is currently open at the Earle A. Chiles Research Institute, a division of Providence Cancer Institute of Oregon. This phase II study will assess the recommended dosing of a combination of two medications with chemotherapy in trial participants.
Combination therapies for advanced breast cancer
Trial participants in this two-arm study will receive the medication tucatinib with trastuzumab and either the chemotherapy gemcitabine or vinorelbine.
Tucatinib is a kinase inhibitor that works by affecting abnormal protein activity, the condition that causes cancer cells to multiply. Trastuzumab is a monoclonal antibody or targeted therapy used to treat breast cancer, sometimes in combination with other medications, such as tucatinib.
Earle A. Chiles Research Institute is currently recruiting 40 participants for this study. Alison Conlin, M.D., MPH, medical director, Providence Breast Cancer Medical Program and High-Risk Breast Cancer Clinic, is the study principal investigator. Providence is the only location in the world currently recruiting for this clinical trial.
Learn more about the study here:
Phase 2 study of tucatinib with chemotherapy and trastuzumab in patients with previously treated, advanced HER2 breast cancer
Clinical trial open for people with HR positive/HER2 negative breast cancer
Where HER2-positive breast cancer is the result of an overproduction of the HER2 receptor, hormone receptor (HR) positive breast cancer occurs when the tumors express increased estrogen receptors (ER) and/or progesterone receptors (PR). A person may be positive for ER, PR, or both, and treatment may include medications that affect hormones.
An investigator-initiated clinical trial at the Earle A. Chiles Research Institute is recruiting people with stage I to stage III HR-positive/HER2 negative (HR+HER-) breast cancer for a clinical trial that seeks to establish the safety of an aromatase inhibitor (letrozole) before surgery in combination with the investigational cancer vaccine DPX-Survivac, DPX-Survivac plus radiation, or DPX-Survivac with cyclophosphamide.
Women with HR+HER2- breast cancer that includes large tumors or cancer in the lymph nodes have shown low response rates to chemotherapy before surgery (standard treatment). In this trial, investigators will test whether administering DPX-Survivac with other therapies such as radiation or low-dose cyclophosphamide, a chemotherapy, can enhance the effectiveness of the vaccine.
DPX-Survivac targets survivin, a protein that is more abundant in HR+HER2- tumors. DPX-Survivac creates a depot at the injection site where survivin antigens are released, exposing the immune system to the therapy for an extended period. The desired outcome of this therapy is a strong and sustained immune response, which may target the immune system to recognize and destroy the tumors.
All trial participants will have surgery to remove the tumor at the end of the study, which could last up to nine weeks. Follow-up of this treatment could last up to five years.
The principal investigator of this trial is Sasha Stanton, M.D., Ph.D., medical oncologist and leader of the Cancer Immunoprevention Laboratory at the Earle A. Chiles Research Institute. Providence is the only location in the world currently recruiting for this clinical trial and is enrolling 18 patients for this trial.
Learn more about the trial here:
Early phase study of DPX-Survivac, aromatase inhibition, and with/without radiotherapy or cyclophosphamide in HR+HER2- breast cancer
For more information about this study or to refer a patient, please contact our Clinical Research office:
- Submit a referral form
- Send an email
See more breast cancer studies
Research studies investigating a broad spectrum of breast cancer therapies and interventions are open at Providence Cancer Institute. We offer studies aimed at improving cure rates, quality of life and survival for early-stage and metastatic breast cancer. These studies range from our own investigator-initiated trials to studies sponsored by the National Cancer Institute.
New studies are added frequently. Visit our website to view all breast cancer studies.
A team of breast cancer specialists
Providence Cancer institute offers a comprehensive, multidisciplinary approach to breast care. Achieving optimal breast health and providing world-class treatment for breast cancer are equal priorities in our continuing goal to improve women's health.
Our clinical and research teams include dedicated breast surgeons, oncologists who specialize exclusively in breast cancer, as well as breast-cancer-focused nurse navigators and research nurses, genetic specialists, nutrition counselors, oncology social workers, laboratory scientists, data coordinators and lab assistants. Every person on this team is passionate about providing the best possible care and the best available treatments for women with breast cancer.
To learn more, visit Providence Breast Cancer Program.
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