Clinical outcomes of breast cancer patients treated in phase I clinical trials at University of Colorado Cancer Center

• Published in: Cancer medicine (Malden, MA) MA), 2020-12, Vol.9 (23), p.8801-8808
• Main Authors: Weiss, Jennifer A., Nicklawsky, Andrew, Kagihara, Jodi A., Gao, Dexiang, Fisher, Christine, Elias, Anthony, Borges, Virginia F., Kabos, Peter, Davis, Sarah L., Leong, Stephen, Eckhardt, Sue Gail, Diamond, Jennifer R.
• Format: Article
• Language: English
• Subjects: Adult; Age; Aged; Aged, 80 and over; Breast cancer; Breast Neoplasms - mortality; Breast Neoplasms - pathology; Breast Neoplasms - therapy; Cancer Care Facilities; Cancer therapies; Chemotherapy; Clinical Cancer Research; Clinical outcomes; Clinical trials; Clinical Trials, Phase I as Topic; Colorado; Enrollments; Epidermal growth factor; ErbB-2 protein; Estrogens; Female; Humans; Immunotherapy; Laboratories; Medical prognosis; Metastases; Metastasis; metastatic breast cancer; Middle Aged; Neoplasm Metastasis; Oncology; Original Research; Patients; phase I clinical trials; Progression-Free Survival; Retrospective Studies; Risk Assessment; Risk Factors; Survival; targeted therapies; Time Factors
• ISSN: 2045-7634; 2045-7634
• DOI: 10.1002/cam4.3487

Patients with metastatic breast cancer (MBC) refractory to standard of care therapies have a poor prognosis. The purpose of this study was to assess patient characteristics and clinical outcomes for patients with MBC treated on phase I clinical trials. We performed a retrospective review of all patients with MBC who were enrolled in phase I clinical trials at the University of Colorado Cancer Center from January 2012 to June 2018. A total of 208 patients were identified. Patients had a mean age of 57 years and received on average 2.1 (range 0‐10) prior lines of chemotherapy. The majority of patients had hormone receptor‐positive/HER2‐negative breast cancer (58.6%) and 30.3% had triple‐negative breast cancer. The median progression free survival (PFS) was 2.8 months (95% CI, 2.3‐3.9) and median overall survival (OS) was 11.5 months (95% CI, 9.6‐13.2). Independent factors associated with longer PFS in multivariable analysis were treatment in a breast cancer‐selective trial or cohort (p = 0.016), age >50 years (p = 0.002), and ≤2 prior lines of chemotherapy in the metastatic setting (p = 0.025). Phase I clinical trials remain a valuable option for select patients with MBC and enrollment should be encouraged when available. We performed a retrospective review of all patients with metastatic breast cancer (MBC) who were enrolled in phase I clinical trials at the University of Colorado Cancer Center. Independent factors associated with longer PFS in multivariable analysis were treatment in a breast cancer‐selective trial or cohort, age >50 years, and ≤2 prior lines of chemotherapy in the metastatic setting. Phase I clinical trials remain a valuable option for selecting patients with MBC and enrollment should be encouraged when available.