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Background <p>Neoadjuvant fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) demonstrated non-inferior cycle 7 pertuzumab and trastuzumab serum trough concentrations (C<sub>trough</sub>), and similar total pathological complete response (tpCR) rates and safety, to intravenous pertuzumab plus trastuzumab (P + H IV) in HER2-positive early breast cancer (eBC). In the FDChina study (NCT04024462), we assessed neoadjuvant–adjuvant PH FDC SC vs. P + H IV in Chinese patients with HER2-positive eBC.</p> Methods <p>Patients received four doxorubicin (60&#xa0;mg/m<sup>2</sup>) plus cyclophosphamide (600&#xa0;mg/m<sup>2</sup>), then four docetaxel (75–100&#xa0;mg/m<sup>2</sup>) cycles, every 3&#xa0;weeks. Patients were randomized 1:1 to PH FDC SC (loading: 1200&#xa0;mg pertuzumab/600&#xa0;mg trastuzumab; maintenance: 600&#xa0;mg/600&#xa0;mg) or P + H IV (loading: 840&#xa0;mg/8&#xa0;mg/kg; maintenance: 420&#xa0;mg/6&#xa0;mg/kg) alongside docetaxel before surgery. Patients then continued HER2-targeted therapy for 14 cycles. Co-primary non-inferiority endpoints: cycle 7 pertuzumab and trastuzumab C<sub>trough</sub>. Secondary endpoints: tpCR, long-term efficacy, safety.</p> Results <p>The lower bounds of the 90% confidence intervals of pertuzumab and trastuzumab cycle 7 geometric mean ratios (0.99 and 1.44, respectively) exceeded the pre-specified non-inferiority margin (0.8). tpCR rates were 55.6% for PH FDC SC vs. 56.4% for P + H IV. Grade ≥ 3 adverse events occurred in 72% vs. 69% of patients.</p> Conclusion <p>The study met the co-primary endpoints of non-inferiority of cycle 7 serum C<sub>trough</sub> for pertuzumab and trastuzumab for PH FDC SC vs. P + H IV. tpCR rates and safety were comparable between arms. PH FDC SC may be a viable treatment option for Chinese patients with HER2-positive eBC.</p>

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The fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in Chinese patients with HER2-positive early breast cancer: primary analysis of the phase III, randomized FDChina study

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  • 发表日期：

    2026年5月7日

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  • Tao Huang,
  • Zhimin Fan,
  • Yongsheng Wang,
  • Xi Yan,
  • Hongjian Yang,
  • Shu Wang,
  • Da Pang,
  • Huiping Li,
  • Haibo Wang,
  • Cuizhi Geng,
  • Liang Huang,
  • Yaqing Sun,
  • Bei Wang,
  • Guofang  Sun,
  • Asna Siddiqui,
  • Eleonora Restuccia,
  • Zhimin Shao

摘要

Background

Neoadjuvant fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) demonstrated non-inferior cycle 7 pertuzumab and trastuzumab serum trough concentrations (Ctrough), and similar total pathological complete response (tpCR) rates and safety, to intravenous pertuzumab plus trastuzumab (P + H IV) in HER2-positive early breast cancer (eBC). In the FDChina study (NCT04024462), we assessed neoadjuvant–adjuvant PH FDC SC vs. P + H IV in Chinese patients with HER2-positive eBC.

Methods

Patients received four doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2), then four docetaxel (75–100 mg/m2) cycles, every 3 weeks. Patients were randomized 1:1 to PH FDC SC (loading: 1200 mg pertuzumab/600 mg trastuzumab; maintenance: 600 mg/600 mg) or P + H IV (loading: 840 mg/8 mg/kg; maintenance: 420 mg/6 mg/kg) alongside docetaxel before surgery. Patients then continued HER2-targeted therapy for 14 cycles. Co-primary non-inferiority endpoints: cycle 7 pertuzumab and trastuzumab Ctrough. Secondary endpoints: tpCR, long-term efficacy, safety.

Results

The lower bounds of the 90% confidence intervals of pertuzumab and trastuzumab cycle 7 geometric mean ratios (0.99 and 1.44, respectively) exceeded the pre-specified non-inferiority margin (0.8). tpCR rates were 55.6% for PH FDC SC vs. 56.4% for P + H IV. Grade ≥ 3 adverse events occurred in 72% vs. 69% of patients.

Conclusion

The study met the co-primary endpoints of non-inferiority of cycle 7 serum Ctrough for pertuzumab and trastuzumab for PH FDC SC vs. P + H IV. tpCR rates and safety were comparable between arms. PH FDC SC may be a viable treatment option for Chinese patients with HER2-positive eBC.