In recognition of October being Breast Cancer Awareness Month, ACRP recently went behind the scenes with a clinical research coordinator on the study team for a bold Cleveland Clinic investigation of a vaccine aimed at preventing triple-negative breast cancer (TNBC), the most aggressive and lethal form of the disease.
Emily (Esakov) Rhoades, PhD, Multisite Investigator Initiated Trial (IIT) Program Manager for the Cleveland Clinic’s Taussig Cancer Institute, provided insights on how the study, currently in Phase Ib in partnership with Anixa Biosciences, Inc., focuses on up to a dozen cancer-free individuals at high risk for developing breast cancer who have decided to voluntarily undergo prophylactic mastectomy to lower their risk. Funded by the U.S. Department of Defense (DoD), the research follows from the work of the late Dr. Vincent Tuohy, which was supported in part by philanthropic gifts from more than 20,000 people over the last 12 years.
ACRP: How does it feel to be working on a trial for such a novel potential treatment that has already gained so much attention and philanthropic support?
Rhoades: All clinical trials I am involved with at Cleveland Clinic are rewarding in their own ways, but the breast cancer vaccine study has been rewarding in a much different way. I started my career at Cleveland Clinic as a postdoctoral fellow in the Lerner Research Institute working on basic science research much like work done in the lab of Dr. Tuohy, where this vaccine originated. As such, the fact that I am now the lead coordinator (program manager) on the first-in-human study of this vaccine feels a bit like coming full circle. To see the public so interested in the potential the alpha-lac vaccine has is very encouraging, and it inspires the team and myself to continue our efforts to move it forward in development.
ACRP: At this early stage with so few participants involved, is the trial mainly focused on safety rather than efficacy, or are signs of efficacy going to be considered?
Rhoades: Currently the trial is primarily being conducted for safety profiling of the vaccine and to determine the mean tolerated and optimal immunologic dose. We have three cohorts of patients open to accrual: women who have had TNBC, women who are currently receiving adjuvant pembrolizumab following treatment for TNBC, and women who have not had breast cancer, but are at a greater genetic risk with a BRCA1/2 or PALB mutation. This wide range of participants allows us to more thoroughly investigate the safety and tolerability of the vaccine.
ACRP: Was any sort of special training provided for coordinators in this study due to the novel nature of the treatment?
Rhoades: All coordinators working on trials involving Investigational New Drug (IND) applications to the U.S. Food and Drug Administration receive training specific for these types of studies. As the vaccine trial has garnered so much public support, the study team (including myself and other coordinators) have remained in close contact with the Cleveland Clinic Corporate Communications team and the Clinical Cancer Research Office to ensure we are being adequately supported and resourced for our individual roles.
ACRP: Does the Cleveland Clinic run enough breast cancer trials that it is able to have coordinators who specialize in them, or are the coordinators involved in this study as likely to be working on trials for a variety of other indications at the same time?
Rhoades: Research coordinators are assigned to a specific disease team (breast, lymphoma, bone marrow transplant, etc.) when hired and then get assigned to studies as they are available. In general, there is an effort for coordinators to gain experience with various types of studies and treatment regimens along with varying sponsor companies and entities. My role is slightly different, as I was hired as a Multisite IIT Program Manager. There are three of us with this title in Cleveland Clinic’s Taussig Cancer Institute. Our job is “lead research coordinator” on clinical trials initiated by a principal investigator (PI) at Cleveland Clinic, wherein the PI is holding the IND at Cleveland Clinic as the lead site, with additional external site (outside Cleveland Clinic) participation. These studies are often more complex, with many moving parts, and require more oversight to ensure regulatory compliance. As such, our team is not assigned to one specific disease team, but instead works across them in support of complex (multisite, DoD/National Cancer Institute-funded, IND/Investigational Device Exemption, etc.) trials originating at Cleveland Clinic. Other disease team–specific research coordinators lead IITs, but the majority of the complex studies and all of the multisite studies are handled by the multisite IIT team.
ACRP: Does having so few participants in this trial make the coordinators’ duties somewhat easier in any way, or harder in some instances?
Rhoades: This is a great question. Having more patients is more of a focus for the clinical (patient facing) members of the study team. For me, the number of patients only affects the frequency and amount of time needed to enter data into the study database. The regulatory tasks are the same in terms of reporting (to the FDA, DoD, and institutional review board) and keeping track of study team personnel documents, regardless of the number of subjects enrolled. Even with no patients enrolled, the research coordinators are required to maintain their studies in the same way as a study with hundreds of participants. Our duties vary more with the complexity (number of open sites, treatment arms, funding/investigational product source) of the study than with the number of subjects.
ACRP: Is there anything about how the coordinators and PI are seeing this study through that we haven’t discussed but you’d like to make note of?
Rhoades: I am very lucky to have such a strong team working with me on this vaccine trial. From the Cancer Center call center (Cancer Answer Line) operators to the clinical team, research team, and phlebotomists, to the quality assurance monitoring group, co-investigators, and beyond, everyone plays a vital role in the study’s success. Specifically, the wholehearted determination and leadership of the late Dr. Vincent Tuohy has propelled this work forward from the very beginning, and I think I speak for the entire team when I say how privileged we feel to be part of such a novel trial with so much potential.
Edited by Gary Cramer
