As the most common cancer among women in the United States after skin cancer, breast cancer is also one of the deadliest, second only to deaths from lung cancer. A phase II, investigator-initiated clinical trial at Providence Cancer Institute aims to improve survival for patients with triple-negative breast cancer (TNBC), a type of breast cancer in which three common receptors – estrogen, progesterone and HER2 – are absent, making it one of the most difficult forms to treat.
The randomized, open-label study will evaluate the clinical and immunologic activity of novel immunotherapy regimens in combination with chemotherapy for TNBC in the neoadjuvant setting. The trial is available only at Providence; find the study details here:
Patients will receive standard-of-care curative-intent chemotherapy (paclitaxel, doxorubicin and cyclophosphamide) combined with pembrolizumab (Keytruda), an immune checkpoint inhibitor which has been demonstrated in recent trials to improve response rate and progression-free survival in metastatic TNBC. Patients are also randomized to potentially receive subcutaneous injections of IRX-2, an experimental cancer immunotherapy.
IRX-2 is a cytokine therapy that is administered in the subcutaneous tissue of the breast. In a phase Ib trial conducted at Providence, IRX-2 was shown to potentially activate immune cells of breast cancer patients, and increase the quantity of immune cells infiltrating the breast tumor. The IRX-2 product is generated in a laboratory setting by artificially stimulating immune cells and concentrating the cytokine product of these activated immune cells.
The study is led by David Page, M.D., medical oncologist and assistant member, Earle A. Chiles Research Institute, a division of Providence. Data from the phase Ib IRX-2 trial(1,2) are published by Dr. Page and colleagues in the journals Breast Cancer Research and Clinical Cancer Research.
Approximately 30 patients will be enrolled to the trial. Patients with stage II/III TNBC are eligible. The primary efficacy endpoint is pathological complete response and patients will be evaluated following definitive surgery.
For more information or to enroll a patient, call our Clinical Research office at 503-215-2614 or submit a referral form.
See more breast cancer studies
Nearly 20 research studies investigating a broad spectrum of breast cancer therapies and interventions are open at Providence Cancer Institute. See all breast cancer studies and multi-indication trials.
New studies are added frequently. Please visit our website to view studies for all types of cancer.
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, 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 study options for patients with breast cancer.
With a vast portfolio of breast cancer clinical trials and therapies, we offer studies aimed at improving cure rates, quality of life and survival for both early-stage and metastatic breast cancer. These studies range from our own investigator-initiated research studies to large international trials, including studies from the National Cancer Institute and pharmaceutical partners.
To learn more, visit Providence Breast Services.
1. Sanchez K, Kim I, Chun B, Pucilowska J, Redmond WL, Urba WJ, Martel M, Wu Y, Campbell M, Sun Z, Grunkemeier G, Chang SC, Bernard B, Page DB. Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer. Breast Cancer Res. 2021 Jan 7;23(1):2. doi: 10.1186/s13058-020-01378-4. PMID: 33413574; PMCID: PMC7788790.
2. Page DB, Pucilowska J, Sanchez KG, Conrad VK, Conlin AK, Acheson AK, Perlewitz KS, Imatani JH, Aliabadi-Wahle S, Moxon N, Mellinger SL, Seino AY, Martel M, Wu Y, Sun Z, Redmond WL, Rajamanickam V, Waddell D, Laxague D, Shah M, Chang SC, Urba WJ. A Phase Ib Study of Preoperative, Locoregional IRX-2 Cytokine Immunotherapy to Prime Immune Responses in Patients with Early-Stage Breast Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1595-1605. doi: 10.1158/1078-0432.CCR-19-1119. Epub 2019 Dec 12. PMID: 31831558.