My doctor has recommended that I consider a breast cancer clinical trial, but …

In Clinical Studies News by Barbara Jacoby

Sponsored by: NYU Winthrop Hospital


Douglas Marks, MD and Nina D’Abreo, MD

…the idea of receiving a treatment that is not yet approved makes me nervous. I thought clinical trials were for patients with no further treatment options?

A: Dr. Douglas Marks: Great question. Medical oncology clinical trials can involve enhanced diagnostic testing, medical treatments and lifestyle interventions. They are often a preferred method of providing care for patients. I routinely consider clinical trial options for my patients, even if FDA-approved treatment options exist, if I believe the trial provides access to a promising innovative diagnostic test or a new drug combination that is likely to be superior to standard therapy. Clinical trials frequently include drugs that are either already approved in breast cancer (or other cancer types) that are being evaluated in combination with different drug partners. That said, clinical trials do also play a very important role in providing treatment options for patients who have exhausted FDA approved clinical options as well.

Not every trial is appropriate for every patient, and your doctor should advise you that these studies represent diagnostic or treatment options that are in development and the risk/benefit ratio is not always certain. Your doctor should also be willing to discuss the existing data that supports the potential benefit of the clinical trial for you specifically.

Dr. Nina D’Abreo: I agree, with Dr. Marks. Clinical trials are one of the main vehicles for offering patients therapy that have promising efficacy prior to being FDA approved. Your doctor should let you know the “phase” of the clinical trial as there are multiple “phases”. Phase 0 or Phase I trials represent the earliest stage in drug development. These trials typically aim to assess a new drug’s (or drug combinations) safety or early effectiveness. Phase II trials are designed to evaluate a drug’s effectiveness, which is often confirmed later in a Phase III trial when compared to another currently approved treatment option. At NYU Winthrop Hospital we have trials for patients with early stage (Stages I-II), locally advanced (Stage III) as well as advanced/metastatic breast cancer (Stage IV).

To schedule an appointment, or to learn more about the NYU Winthrop Breast Health Program, visit or call 1-866-WINTHROP.

Douglas Marks, MD

Dr. Douglas Marks is an Attending Physician in the Division of Oncology/Hematology at NYU Winthrop Hospital, having joined the Hospital following a fellowship program in Oncology/Hematology at Columbia University Medical Center. Dr. Marks also serves as a Clinical Instructor with a primary clinical focus on breast cancer. Dr. Marks was awarded an American Association for Cancer Research (AACR) Scholar in Training Award in 2017 and is currently involved in several research endeavors focused on better understanding the interaction between an individual patient’s immune system and breast cancer.

Nina D’Abreo, MD 

Dr. Nina D’Abreo is an attending physician in the department of Oncology and Hematology at NYU Winthrop Hospital and is the Medical Director of NYU Winthrop’s Breast Cancer Service. She serves on the breast cancer advisory committee, which is dedicated to improving all aspects of breast health, and is responsible for developing the breast clinical trials program. Dr. D’Abreo currently serves as the local principal investigator for many breast cancer clinical trials at NYU Winthrop which are designed for breast cancer prevention, and early stage and metastatic breast cancer. Dr. D’Abreo did her fellowship in Hematology and Oncology at Drexel School of Medicine, Hahnemann Hospital Campus, where she was also Chief Fellow. She is an Assistant Professor of Medicine at SUNY Stony Brook and has a particular interest in personalized treatment of breast cancer and breast cancer survivorship.