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PreprintCC BY-NCmedRxiv

FORESEE: A prospective feasibility trial of functional precision oncology for metastatic breast cancer patients

  • C. Vaklavas
  • S. S. Buys
  • S. D. Scherer
  • K. Kelley
  • L. Zhou
  • C.-H. Yang
  • E. Cortes-Sanchez
  • A. Butterfield
  • X. Huang
  • P. J. Moos
  • Y. Qiao
  • J. Reed
4 more authors
  • K. M. Boucher
  • G. Marth
  • B. E. Welm1
  • A. L. Welm1
  1. 1University of Utah
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Abstract

The FORESEE trial (NCT04450706) was a prospective study to evaluate the feasibility of integrating organoid-based drug testing with comprehensive genomic characterization to inform treatment selection in patients with HER2-negative metastatic breast cancer. The primary objective of the study was to determine the feasibility of providing personalized therapy recommendations using a combination of genomic vulnerability information with drug testing in patient-derived organoids (PDOs) in a clinically relevant time frame. Of the 15 patients enrolled, 10 cases had biopsies with adequate tumor content, and PDOs were successfully established in 4 of 10 cases. Drug profiling and genomic testing was completed in all established organoids, yielding an overall success rate of 40% in cases of biopsies with adequate tumor content. Drug sensitivity and genomic results were returned within 12 weeks and informed subsequent treatment selection in all evaluable cases. The primary endpoint - demonstrating that PDO-based drug screening combined with genomic characterization would identify clinically actionable outcomes in at least 46% of patients based on prior data - was not met. In conclusion, successful PDO establishment represents a limiting step in the implementation of FPO for metastatic breast cancer. These findings highlight the need for improved strategies optimizing use of patient biopsy material for drug testing to fully realize the clinical potential of FPO.

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Cite

BibTeXRIS
BibTeX
@misc{vaklavas2026foresee,
  title = {{FORESEE: A prospective feasibility trial of functional precision oncology for metastatic breast cancer patients}},
  author = {C. Vaklavas and S. S. Buys and S. D. Scherer and K. Kelley and L. Zhou and C.-H. Yang and E. Cortes-Sanchez and A. Butterfield and X. Huang and P. J. Moos and Y. Qiao and J. Reed and K. M. Boucher and G. Marth and B. E. Welm and A. L. Welm},
  howpublished = {medRxiv},
  year = {2026},
  month = oct,
  doi = {10.64898/2026.10.10.26365226},
  url = {https://www.medrxiv.org/content/10.64898/2026.10.10.26365226v1},
  note = {CC BY-NC},
}
RIS
TY  - UNPB
TI  - FORESEE: A prospective feasibility trial of functional precision oncology for metastatic breast cancer patients
AU  - C. Vaklavas
AU  - S. S. Buys
AU  - S. D. Scherer
AU  - K. Kelley
AU  - L. Zhou
AU  - C.-H. Yang
AU  - E. Cortes-Sanchez
AU  - A. Butterfield
AU  - X. Huang
AU  - P. J. Moos
AU  - Y. Qiao
AU  - J. Reed
AU  - K. M. Boucher
AU  - G. Marth
AU  - B. E. Welm
AU  - A. L. Welm
PY  - 2026
DA  - 2026/10/10
PB  - medRxiv
DO  - 10.64898/2026.10.10.26365226
UR  - https://www.medrxiv.org/content/10.64898/2026.10.10.26365226v1
AB  - The FORESEE trial (NCT04450706) was a prospective study to evaluate the feasibility of integrating organoid-based drug testing with comprehensive genomic characterization to inform treatment selection in patients with HER2-negative metastatic breast cancer. The primary objective of the study was to determine the feasibility of providing personalized therapy recommendations using a combination of genomic vulnerability information with drug testing in patient-derived organoids (PDOs) in a clinically relevant time frame. Of the 15 patients enrolled, 10 cases had biopsies with adequate tumor content, and PDOs were successfully established in 4 of 10 cases. Drug profiling and genomic testing was completed in all established organoids, yielding an overall success rate of 40% in cases of biopsies with adequate tumor content. Drug sensitivity and genomic results were returned within 12 weeks and informed subsequent treatment selection in all evaluable cases. The primary endpoint - demonstrating that PDO-based drug screening combined with genomic characterization would identify clinically actionable outcomes in at least 46% of patients based on prior data - was not met. In conclusion, successful PDO establishment represents a limiting step in the implementation of FPO for metastatic breast cancer. These findings highlight the need for improved strategies optimizing use of patient biopsy material for drug testing to fully realize the clinical potential of FPO.
ER  -