NCT03923166

Pyrotinib Combined With Capecitabine Metronomic Therapy in HER2-postitive Advanced Breast Cancer

Status unknown Phase 2 Last updated 22 April 2019

What this trial tests

Phase 2 trial testing Pyrotinib in Breast Cancer in 35 participants. Status unknown.

Timeline

19 April 2019

Primary endpoint
1 April 2021

31 December 2021

Quick facts

Lead sponsor	Chinese Academy of Medical Sciences
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	19 April 2019
Primary completion	1 April 2021
Estimated completion	31 December 2021
Sites	1 location across China

Drugs / interventions tested

• Pyrotinib — full drug profile →
• capecitabine (capecitabine) — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Chinese Academy of Medical Sciences — full company profile →

Who can join

Adults 18 to 75, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Overexpression of the HER2 gene accounts for 20% to 30% of breast cancer. Although trastuzumab combined with chemotherapy has become the basic treatment for patients with HER2-positive advanced breast cancer, For patients who have progressed or relapsed after trastuzumab treatment, There are still many issues to explore on the choice of program of retargeted therapy. In HER2-positive advanced breast cancer, the results of Phase I and Phase I/II trials of pyrotinib or pyrotinib combined with capecitabine show that the anti-tumor effect is rapid, efficient and sustainable, and the patient is safe and well tolerated. Capecitabine is an oral cytotoxic drug that has high selectivity and specificity against tumors. Many patients need to adjust the dose due to adverse reactions, especially for patients after multi-line treatment. Previous studies have shown that sustained low-dose capecitabine reduces the adverse effects of the drug while ensuring efficacy. Based on the above, this study is to conduct a single-center, one-arm phase II clinical trial to explore the efficacy and safety of pyrotinib and capecitabine in the treatment of HER2-positive advanced breast cancer.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mechanism, safety and efficacy of three tyrosine kinase inhibitors lapatinib, neratinib and pyrotinib in HER2-positive breast cancer.
   Xuhong JC, Qi XW, Zhang Y, Jiang J. · · 2019 · cited 118× · PMID 31720077
2. Metronomic chemotherapy and drug repurposing: A paradigm shift in oncology.
   Jan N, Sofi S, Qayoom H, Shabir A, et al · · 2024 · cited 26× · PMID 38314272 · DOI 10.1016/j.heliyon.2024.e24670
3. Current Research Status of Metronomic Chemotherapy in Combination Treatment of Breast Cancer.
   Liu J, He M, Wang Z, Li Q, et al · · 2022 · cited 17× · PMID 35988534 · DOI 10.1159/000526481
4. Safety and efficacy study of oral metronomic capecitabine combined with pyrotinib in HER2-positive metastatic breast cancer: A phase II trial.
   He M, Liu J, Wang Z, Ma F, et al · · 2023 · cited 2× · PMID 37742492 · DOI 10.1016/j.breast.2023.103581