Demystifying Oncology Clinical Trials

Douglas K Marks, MD lectures on the importance of clinical trials in both early access to innovative therapies while also defining what will be the future standard of care.

At a glance:


AIM: Discuss the role of oncology clinical trials in the provision of early access to innovative therapies for patients while defining future standard of care treatments.

Target Audience: patients and caregivers

Learning Objectives:
1) Review a timeline of recent drug approvals in breast cancer
2) Review the phases of clinical trials (I→II→III)
3) Provide 2 case studies for recently approved drugs in ER+/HER-2 negative breast
cancer (e.g. Elacestrant, Capivasertib)
4) Discuss select promising new therapies in earlier stages of development (e.g. CDK4 ,


(This lecture is part of our Empowering Women In The Face Of Cancer: Navigating The Path Forward)

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The Lecturer(s)

Douglas K Marks, MD

Douglas K Marks, MD

I chose to pursue a career in medicine because it combines my scientific interest in human biology and pharmacology and my personal interest in positively contributing to the people in my community. As a medical oncologist, it is my responsibility and privilege to care for patients during the most difficult periods in their lives. I specialize in the treatment of breast cancer and provide my patients with the most up-to-date and innovative oncologic care. I am proud to have a career that allows me to establish longstanding relationships with my patients and to continue to offer new therapies associated with better outcomes. In addition to maintaining and constantly improving my expertise, I aspire to educate my patients so that they are also experts in their own disease. I think of each patient as a unique individual and work collaboratively with each patient to come up with the very best treatment plan for them. Maintaining a healthy lifestyle is very important for both cancer prevention and effective cancer treatment. At Perlmutter Cancer Center, I work closely with members of a multidisciplinary team—including other medical specialists such as breast surgeons, radiation oncologists, and plastic surgeons, as well nutritionists, physical therapists, and social workers—in order to provide the most comprehensive and highest quality care to my patients throughout their treatment. Outside of my clinical practice, I have an interest in immunotherapy and I am currently a collaborator on several translational research projects aimed at broadening the efficacy of immunotherapy in breast cancer and other solid malignancies. Prior to entering clinical practice, I worked in a lab using genomic and nongenomic pathology platforms to study the effects between cancer therapeutics and the immune system. I am investigator on multiple clinical trials that are evaluating the activity of newly developed therapeutic agents in breast cancer and other solid malignancies. Clinical trials are critically important as they can provide early access to promising treatment options for individual patients, as well as provide knowledge that benefits the broader patient population. I am also interested in nonmedical and lifestyle related interventions to reduce the risk of breast cancer. My research projects have been presented at the San Antonio Breast Cancer Symposium—an international symposium focused on the treatment of breast cancer—in addition to presentations at the American Association for Cancer Research (AACR), the American Society of Clinical Oncology, the Society for Immunology of Cancer, and at the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network Cancer Research Group meeting, as well as published in peer reviewed journals. I was awarded an AACR Scholar-in-Training Award in 2017.

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Douglas K Marks, MD

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Douglas K Marks, MD


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