Continued Access to Treatment for Patients Withdrawing from Clinical Trials

In 2020, 2.3 million women worldwide were diagnosed with breast cancer, with nearly 685,000 deaths, making it one of the most prevalent cancers globally. In Malaysia, it has been the most common cancer among women and accounted for 19% of all new cancer cases^1,2 between 2012 and 2016.

In February 2018, a 55-year-old woman from a remote Indigenous settlement in Malaysia was diagnosed with stage I breast cancer. During her visit to the nearest hospital for a breast evaluation, after discovering a lump the size of a grape on her left breast, the breast surgeon ordered a biopsy confirming that she had a tumor that was hormonally driven (HR-positive) but absent a molecular marker (HER2) that can be targeted by certain treatments. The surgeon removed the lump and provided radiation treatment. In May 2019, she noticed another growing lump on her left breast and her left underarm. Her doctor notified her that her cancer had spread to her lymph nodes, therefore requiring a more aggressive treatment. Her breast surgeon suggested a few adjuvant therapies, including Verzenio, which is currently available through a research study being conducted at a university hospital 3 hours away by car. This new type of drug is reported to show significant reduction in tumor growth and size for women with HR-positive and HER2-negative advanced or metastatic breast cancer. Her breast surgeon suggested that this patient consider joining the clinical trial as she fits the recruitment criteria. The woman decided to take the breast surgeon’s advice and was then recruited into the research study at the university hospital at no cost to her.

The lead researcher at the university hospital conducted a routine informed consent interview, explaining the treatment and procedure, and she agreed to participate. A few weeks into the clinical trial, the woman began hearing rumors from other research participants about a harmful side effect of the drug. Online reports associated Verzenio with severe lung inflammation in patients participating in other trials involving the same drug³. The woman told the lead researcher she wanted to withdraw from the clinical trial, stating her loss of confidence in the safety of the study medication. Disappointed with this decision, the lead researcher tried to reassure the patient to remain in the trial, stating that her withdrawal from the study would result in her losing access to clinical care in the university hospital.