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Recruiting Phase 3

Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer

NCT04646759 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2020-10-14
Last updated
2020-11-30

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Fulvestrant combined with PyrotinibAll Fulvestrant trials (132) →All Pyrotinib trials (51) →Capecitabine combined with PyrotinibAll Capecitabine trials (327) →All Pyrotinib trials (51) →

Fulvestrant combined with Pyrotinib: Fulvestrant 500mg was injected intramuscularly on D1, D15, D28 and D28 Pyrotinib 400mg daily

Capecitabine combined with Pyrotinib: Capecitabine 1000mg/m\^2 bid d1-d14,every 21 days Pyrotinib 400mg daily

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Adult female patients (aged 18-80 years, including 18 and 80 years) with metastatic breast cancer confirmed by pathology or imaging are not suitable for surgical resection or radiotherapy for the purpose of cure; 2. Pathological examination confirmed that ER and / or PR were positive, and HER-2 was positive (ER expression: immunohistochemical staining of tumor cells ≥ 10%; PR expression: immunohistochemical staining of tumor cells ≥ 10%; HER-2 positive: immunohistochemical staining of 3 + or fish positive); 3. Postmenopausal patients (for premenopausal patients, ofs includes bilateral ovariectomy and GnRHa drugs); 4. The disease-free interval between the end of the last trastuzumab and tumor progression was more than 12 months; 5. Trastuzumab has not been treated or only received first-line treatment based on trastuzumab for metastatic diseases, and trastuzumab should be evaluated as effective in the rescue treatment of metastatic breast cancer for the first time. 6. Patients who have received chemotherapy and endocrine therapy in the past (New) adjuvant or for metastatic diseases, and have disease progression during or after treatment; 7. The WHO physical status was 0-2 points, and the expected survival time was not less than 3 months; 8. At least one measurable lesion (short diameter of lymph node ≥ 15mm) was detected in the imaging examination within 2 weeks before enrollment, including normal CT scan ≥ 20 mm, spiral CT scan diameter ≥ 10 mm, or simple bone metastasis. 9. Previous treatment related toxicity should be reduced to NCI CTCAE (version 5.0) ≤ 1 degree (except for hair loss or other toxicity which is judged by the researcher to be safe for the patient) 10. Within one week before admission, blood routine examination was basically normal: A. white blood cell count (WBC) ≥ 3.0 × 10 \^ 9 / L; B. neutrophil count (ANC) ≥ 1.5 × 10 \^ 9 / L; C. platelet count (PLT) ≥ 100 × 10 \^ 9 / L; 11. 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 × upper limit of normal value (ULN), B. alanine aminotransferase (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. Exclusion Criteria: You cannot be grouped if you meet any of the following: 1. Patients who had not received trastuzumab, chemotherapy and endocrine therapy before; 2. Patients with central nervous system metastasis and clinical symptoms; 3. Patients with visceral crisis; 4. Patients who were considered suitable for chemotherapy by the researchers; 5. There are many factors that affect drug administration and absorption, such as dysphagia, chronic diarrhea and intestinal obstruction. 6. Patients who received radiotherapy, chemotherapy, endocrine therapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before enrollment. 7. He participated in other clinical trials within 4 weeks before enrollment. 8. Patients with metastatic disease received more than first-line endocrine therapy, chemotherapy or targeted therapy. 9. Other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma. 10. At the same time, they received any other anti-tumor treatment. 11. Those who have been known to have allergic history to the drug components of this regimen; have a history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation. 12. Severe heart disease or discomfort, including, but not limited to, the following: a history of heart failure or systolic dysfunction (LVEF \< 50%); high risk uncontrolled arrhythmias such as atrial tachycardia, resting heart rate \> 100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e., mobitz) The results showed that there was no significant difference between the two groups (systolic blood pressure \> 180 mmHg and diastolic blood pressure \> 100 mmHg); 13. Pregnant and lactating women, fertile women with positive baseline pregnancy test. 14. According to the judgment of the researchers, there are some accompanying diseases that seriously endanger the safety of patients or affect patients to complete the study. 15. Have a clear history of neurological or mental disorders, including epilepsy or dementia. 16. Any other situation in which the researcher believes that the patient is not suitable for the study, which may interfere with the accompanying diseases or conditions of the study, or have any serious medical obstacles that may affect the safety of the subjects (such as uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection)

Primary outcome measure(s)

  • Progression free survival — 24 months
    The interval from the date of randomization to the first imaging confirmed progression of disease or death from any cause.
  • Incidence of grade 3 hand foot syndrome (rate) — From the date of enrollment to one year
    From the date of enrollment to one year, the incidence of grade 3 hand-foot syndrome in the fulvestrant combined with pyrotinib group was compared with that of capecitabine combined with pyrotinib group. The incidence and severity of hand-foot syndrome were evaluated according to CTCAE 5.0 every 9 weeks (± 7 days).

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04646759 on ClinicalTrials.gov ↗ ← All trials in China