NCT04001621

Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer

Status unknown Phase 2 Last updated 8 December 2022

What this trial tests

Phase 2 trial testing Pyrotinib combined with capecitabine in Metastatic Breast Cancer in 100 participants. Status unknown.

Timeline

26 June 2019

Primary endpoint
31 May 2023

31 December 2023

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	26 June 2019
Primary completion	31 May 2023
Estimated completion	31 December 2023
Sites	1 location across China

Drugs / interventions tested

• Pyrotinib combined with capecitabine — full drug profile →

Conditions studied

• Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Fudan University

Who can join

Adults 18 to 70, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Trastuzumab resistance, which is a common therapeutic challenge in HER2 positive metastatic breast cancer, is not fully understood. Pyrotinib is an oral tyrosine kinase inhibitor targeting EGFR, HER-2 and HER-4 receptors. More general inhibition of ErbB family with pyrotinib could provide additional benefit. This study is designed to evaluate the efficacy and safety of pyrotinib in combination with capecitabine in patients with HER2 positive locally advanced or metastatic breast cancer who had early failure on or after trastuzumab treatment.

Publications & conference data

8 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. Chemoresistance in breast cancer: PI3K/Akt pathway inhibitors vs the current chemotherapy.
   Kaboli PJ, Imani S, Jomhori M, Ling KH. · · 2021 · cited 51× · PMID 34765318
3. Beyond HER2: Targeting the ErbB receptor family in breast cancer.
   Drago JZ, Ferraro E, Abuhadra N, Modi S. · · 2022 · cited 39× · PMID 35870237 · DOI 10.1016/j.ctrv.2022.102436
4. New Therapeutics in HER2-Positive Advanced Breast Cancer: Towards a Change in Clinical Practices?pi.
   Mezni E, Vicier C, Guerin M, Sabatier R, et al · · 2020 · cited 22× · PMID 32545895 · DOI 10.3390/cancers12061573
5. Pyrotinib plus capecitabine for trastuzumab-resistant, HER2-positive advanced breast cancer (PICTURE): a single-arm, multicenter phase 2 trial.
   Cao J, Teng Y, Li H, Zhang L, et al · · 2023 · cited 16× · PMID 37559142 · DOI 10.1186/s12916-023-02999-0
6. Treating Advanced Unresectable or Metastatic HER2-Positive Breast Cancer: A Spotlight on Tucatinib.
   Ulrich L, Okines AFC. · · 2021 · cited 13× · PMID 34079368 · DOI 10.2147/bctt.s268451
7. Management and Mechanisms of Diarrhea Induced by Tyrosine Kinase Inhibitors in Human Epidermal Growth Factor Receptor-2-Positive Breast Cancer.
   Sun K, Wang X, Zhang H, Lin G, et al · · 2024 · cited 8× · PMID 39159918 · DOI 10.1177/10732748241278039
8. Pathological Complete Response from Pyrotinib Combined with Trastuzumab, Paclitaxel and Cisplatin in a Postpartum Woman with HER2-Positive Locally Advanced Breast Cancer: A Case Report.
   He L, Zhang F, Ma Y, Zuo L, et al · · 2020 · cited 3× · PMID 32943881 · DOI 10.2147/ott.s252117