KEY TAKEAWAYS
- PRECIOUS (NCT02514681) Phase 3 study sought to evaluate the effect of trastuzumab for HER2-positive breast cancer.
- The primary objective was to evaluate and assess the effectiveness of retreatment with pertuzumab following disease progression from pertuzumab-containing therapy for HER2-positive Breast cancer.
- The study was a randomized, open-label trial in 93 locations in Japan.
- The outcome showed that PFS was 5.3 months in the PTC group and 4.2 months in the TC group. Overall survival and response length are better in the PTC group.
Until 2020, patients with HER2-positive advanced breast cancer receiving second-line trastuzumab emtansine therapy had no standard treatment alternatives. This research aimed to assess the effectiveness of retreatment with pertuzumab following disease progression from pertuzumab-containing therapy for HER2-positive locally advanced or metastatic breast cancer. There were 93 locations in Japan where this phase III trial was conducted, and it was randomized and open-label for all participants.
In this study, patients with HER2-positive breast cancer who had previously been treated with trastuzumab, pertuzumab, and chemotherapy in first- and/or second-line settings were randomly assigned (1:1) to receive either. Pertuzumab, trastuzumab, and physician’s choice chemotherapy (PTC) or trastuzumab and physician’s choice chemotherapy.
Investigator-assessed progression-free survival (PFS) was the major endpoint. Randomization occurred between August 1, 2015, and December 31, 2018, with 219 patients receiving either PTC (n = 110) or TC (n = 109).
PFS was 5 months 3 weeks (95% CI, 4.0-6.6) with PTC and 4 months and 2 weeks (95% CI, 3.2-4.8) with TC (stratified hazard ratio 0.76 [95% CI upper limit 0.967]; p = 0.022) after a median follow-up of 14.2 months (IQR, 9.0-22.2). The addition of pertuzumab increased progression-free survival across all subgroups that were considered.
Overall survival and response length tended to be better in the PTC group, whereas objective response and health-related quality of life were similar. Except for diarrhea, the frequency of treatment-related side events was comparable between groups. Patients with HER2-positive locally advanced or metastatic breast cancer who have previously been treated with pertuzumab-containing regimens benefit from retreatment with the drug.
Source: https://pubmed.ncbi.nlm.nih.gov/35754298/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT02514681
Yamamoto, Y., Iwata, H., Taira, N., Masuda, N., Takahashi, M., Yoshinami, T., Ueno, T., Toyama, T., Yamanaka, T., Takano, T., Kashiwaba, M., Tsugawa, K., Hasegawa, Y., Tamura, K., Tada, H., Hara, F., Fujisawa, T., Niikura, N., Saji, S., & Morita, S. (2022). Pertuzumab retreatment for HER2‐positive advanced breast cancer: A randomized, open‐label phase III study (PRECIOUS). Cancer Science, 113(9), 3169–3179. https://doi.org/10.1111/cas.15474
