Patients With Advanced Breast Cancer Denied Opportunities to Join Clinical Trials

By Megan Brooks

November 12, 2021

NEW YORK (Reuters Health) - Very few patients with advanced breast cancer are asked to participate in clinical trials that could lead to improved outcomes, according to a U.K. survey.

"Clinicians act as gatekeepers and this study shows that they often don't mention or discuss trials. They hold a lot of the power in the relationship and we need to encourage them to discuss trials as a treatment option with their patients," patient advocate Lesley Stephen said in a news release from the Advanced Breast Cancer Sixth International Consensus Conference (ABC 6), where she presented the findings.

Stephen was diagnosed with metastatic breast cancer (MBC) in 2014 and entered a clinical trial at the Beatson Glasgow Cancer Center; she remains on the same treatment.

"I have been on a clinical trial for almost six years, and it has given me six years of life I never expected to have. Since my diagnosis and after talking with other advanced breast cancer patients, I realized that most had never had a conversation with their clinician about a clinical trial. I wanted to understand why this was," Stephen said.

She teamed up with Dr. Carlo Palmieri, a consultant in medical oncology at The Clatterbridge Cancer Centre, Dr. Janet Dunn, head of the Warwick Clinical Trials unit at the University of Warwick and Dr. Ellen Copson, associate professor of medical oncology at the University of Southampton, to conduct a U.K.-wide online survey. The survey remains open.

At the meeting, Stephen reported findings based on 627 MBC patients (median age, 55 years; one male) who responded to the survey.

When asked about clinical trials, 83% of respondents knew about clinical trials, but only 14% had been recruited into one; 77% had never been approached about entry into a clinical trial and 69% had not asked their clinician about trials.

Efforts are needed to "empower" patients to start conversations about clinical-trial participation with their provider, Stephen told the conference.

She noted that of the 14% of MBC patients who have participated in a trial, 80% found it a positive experience.

The 31% of respondents who inquired about clinical trials received responses that varied from positive and supportive to vague and dismissive, Stephen said.

When asked about traveling for clinical-trial participation, 56% of patients were willing to travel, with 25% willing to pay over £100 (US$135) per month to do so. If travel costs were covered, the proportion willing to travel to participate in a trial increased to 61%.

When asked about the benefits to participation in clinical trials, 93% felt it would provide early access to potential new drugs and 90% felt it would help future patients. However, 63% of patients voiced concern about the possible side effects of treatment and 43% were unsure of the potential benefits.

The preferred sources of information regarding clinical trials were doctors (78%) and nurses (61%).

In the news release, Dr. Fatima Cardoso, director of the Breast Unit of the Champalimaud Clinical Center in Lisbon, Portugal, and chair of the ABC 6 conference, encouraged all stakeholders - clinicians, researchers, the pharmaceutical industry, academic groups and funders - to work together to address this problem.

"This is not just a problem in the U.K. It is difficult in most countries for patients with advanced breast cancer to join clinical trials and, in some countries, it is impossible. This needs to change urgently in order to find new therapies and provide better care for these patients," Dr. Cardoso said.

"That clinical trial enrollment is low, especially in those over 65 years old, is not new," Dr. Charles Shapiro, professor of medicine, hematology and medicinal oncology at Icahn School of Medicine at Mount Sinai, In New York City, told Reuters Health by email.

In this survey, "only slightly more than 20% of oncologists discussed clinical trials with women. All the usual suspects were found in the survey including the costs, travel time, extra visits, not understanding the trial or its benefits, and time off work for participating in a trial," Dr. Shapiro said.

"The two take-home points are both sides of the same coin. Namely, we must design trials that are simpler and acknowledge that women have lives outside of the oncologist's office. With simpler trials that focus on the important questions, there might be an increase in the willingness for oncologists to offer the trial. Studies that raise awareness of how bad we are with respect to clinical-trial accrual are justified," Dr. Shapiro told Reuters Health.

SOURCE: Advanced Breast Cancer Sixth International Consensus Conference (ABC 6), held November 4-6, 2021.