OncoMatch/Clinical Trials/NCT04646759
Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer
Is NCT04646759 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Fulvestrant combined with Pyrotinib and Capecitabine combined with Pyrotinib for breast cancer.
Treatment: Fulvestrant combined with Pyrotinib · Capecitabine combined with Pyrotinib — Capecitabine combined with pyrotinib is the standard protocol for HR+/HER2+ advanced breast cancer after trastuzumab failure, but the incidence of grade 3 hand-foot-syndrome was 16.4%. Therefore, the search for efficient and low toxicity alternatives has become a research hotspot. Our previous basic studies have shown that ER inhibitor fulvestrant and HER2 inhibitor pyrotinib have a synergistic effect. The preliminary analysis of our prospective shows that the efficacy is close to that of capecitabine combined with pyrotinib, and the adverse events are significantly improved compared with capecitabine combined with pyrotinib. Therefore, it is necessary to further carry out a head-to-head phase III randomized controlled clinical trial to study the efficacy and safety of fulvestrant combined with pyrotinib in the treatment of HR + / HER2 + advanced breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 positive (immunohistochemical staining of tumor cells ≥ 10%)
ER and / or PR were positive (ER expression: immunohistochemical staining of tumor cells ≥ 10%)
Required: PR (PGR) positive (immunohistochemical staining of tumor cells ≥ 10%)
ER and / or PR were positive (PR expression: immunohistochemical staining of tumor cells ≥ 10%)
Required: HER2 (ERBB2) positive (IHC 3+ or FISH positive)
HER-2 was positive (immunohistochemical staining of 3 + or fish positive)
Disease stage
Metastatic disease required
Performance status
WHO 0–2
Prior therapy
Must have received: trastuzumab (trastuzumab) — adjuvant or metastatic
The disease-free interval between the end of the last trastuzumab and tumor progression was more than 12 months
Must have received: chemotherapy — adjuvant or metastatic
Patients who have received chemotherapy ... in the past (New) adjuvant or for metastatic diseases, and have disease progression during or after treatment
Must have received: endocrine therapy — adjuvant or metastatic
Patients who have received ... endocrine therapy in the past (New) adjuvant or for metastatic diseases, and have disease progression during or after treatment
Cannot have received: trastuzumab (trastuzumab)
Exception: patients who have not received trastuzumab before are excluded
Patients who had not received trastuzumab, chemotherapy and endocrine therapy before
Cannot have received: chemotherapy
Exception: patients who had not received chemotherapy before are excluded
Patients who had not received trastuzumab, chemotherapy and endocrine therapy before
Cannot have received: endocrine therapy
Exception: patients who had not received endocrine therapy before are excluded
Patients who had not received trastuzumab, chemotherapy and endocrine therapy before
Cannot have received: endocrine therapy
Exception: patients with metastatic disease received more than first-line endocrine therapy are excluded
Patients with metastatic disease received more than first-line endocrine therapy, chemotherapy or targeted therapy
Cannot have received: chemotherapy
Exception: patients with metastatic disease received more than first-line chemotherapy are excluded
Patients with metastatic disease received more than first-line endocrine therapy, chemotherapy or targeted therapy
Cannot have received: targeted therapy
Exception: patients with metastatic disease received more than first-line targeted therapy are excluded
Patients with metastatic disease received more than first-line endocrine therapy, chemotherapy or targeted therapy
Cannot have received: radiotherapy
Patients who received radiotherapy, chemotherapy, endocrine therapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before enrollment
Cannot have received: chemotherapy
Patients who received radiotherapy, chemotherapy, endocrine therapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before enrollment
Cannot have received: endocrine therapy
Patients who received radiotherapy, chemotherapy, endocrine therapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before enrollment
Cannot have received: molecular targeted therapy
Patients who received radiotherapy, chemotherapy, endocrine therapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before enrollment
Lab requirements
Blood counts
WBC ≥ 3.0 × 10^9/L; ANC ≥ 1.5 × 10^9/L; PLT ≥ 100 × 10^9/L
Kidney function
serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml/min
Liver function
total bilirubin (TBIL) ≤ 1.5 × ULN, ALT/AST ≤ 2.5 × ULN (liver metastasis patients ≤ 5x ULN)
Cardiac function
LVEF ≥ 55%, QTcF ≤ 470 ms
blood routine examination was basically normal: ... Liver, kidney and heart function tests were basically normal within one week before enrollment (based on the normal values of laboratories in each research center): A. total bilirubin (TBIL) ≤ 1.5 × ULN, B. ALT/AST ≤ 2.5 × ULN (liver metastasis patients ≤ 5xuln), C. serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml / min; D. left ventricular ejection fraction (LVEF) ≥ 55%, e. QTcF(Fridericia correction) ≤ 470 ms.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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