Patient perspectives on window of opportunity clinical trials in early-stage breast cancer

Breast Cancer Res Treat. 2022 Jul;194(1):171-178. doi: 10.1007/s10549-022-06611-6. Epub 2022 May 11.


Purpose: Window of opportunity trials (WOT) are increasingly common in oncology research. In WOT participants receive a drug between diagnosis and anti-cancer treatment, usually for the purpose of investigating that drugs effect on cancer biology. This qualitative study aimed to understand patient perspectives on WOT.

Methods: We recruited adults diagnosed with early-stage breast cancer awaiting definitive therapy at a single-academic medical center to participate in semi-structured interviews. Thematic and content analyses were performed to identify attitudes and factors that would influence decisions about WOT participation.

Results: We interviewed 25 women diagnosed with early-stage breast cancer. The most common positive attitudes toward trial participation were a desire to contribute to research and a hope for personal benefit, while the most common concerns were the potential for side effects and how they might impact fitness for planned treatment. Participants indicated family would be an important normative factor in decision-making and, during the COVID-19 pandemic, deemed the absence of family members during clinic visits a barrier to enrollment. Factors that could hinder participation included delay in standard treatment and the requirement for additional visits or procedures. Ultimately, most interviewees stated they would participate in a WOT if offered (N = 17/25).

Conclusion: In this qualitative study, interviewees weighed altruism and hypothetical personal benefit against the possibility of side effect from a WOT. In-person family presence during trial discussion, challenging during COVID-19, was important for many. Our results may inform trial design and communication approaches in future window of opportunity efforts.

Keywords: Breast cancer; Clinical trials; Patient perspectives; Window of opportunity.

MeSH terms

  • Adult
  • Breast Neoplasms* / drug therapy
  • Breast Neoplasms* / therapy
  • COVID-19*
  • Clinical Trials as Topic
  • Communication
  • Female
  • Humans
  • Pandemics
  • Qualitative Research