Pyrotinib with trastuzumab and aromatase inhibitors as first-line treatment for HER2 positive and hormone receptor positive metastatic or locally advanced breast cancer: study protocol of a randomized controlled trial.

Abstract

BACKGROUND:

HER2 dual-blockade combined with aromatase inhibitors (AI) is a promising strategy to improve progression-free survival (PFS) in hormone receptor (HR) positive, metastatic breast cancer (MBC). Pyrotinib is a novel irreversible epidermal growth factor receptor/HER2 dual tyrosine kinase inhibitor. However, there is scarcity of data on the effectiveness and safety of pyrotinib combined with trastuzumab and AI as first-line treatment in a metastatic setting.

METHODS/DESIGN:

The present study is a prospective, randomized, open-label trial. 198 patients with HER2+/HR+ MBC will be recruited. Eligible patients will be allocated (2:1) to either an experimental group (pyrotinib + trastuzumab + AI) or a control group (trastuzumab + AI). Allocation will be stratified by 1) time since adjuvant hormone therapy (≤ 12 months/> 12 months/no prior hormone therapy); 2) lesion sites (visceral / non-visceral). The primary endpoint is PFS.

DISCUSSION:

To our knowledge, this is the first prospective randomized controlled trial to assess dual HER2-blockade with pyrotinib in the metastatic setting. This study will provide valuable evidence regarding the efficacy and safety of pyrotinib when combined with trastuzumab and an AI as first-line treatment for MBC. Moreover, it will also evaluate the feasibility of endocrine therapy as an alternative to chemotherapy in providing de-escalation therapy with less toxicity for advanced HR+/HER2+ patients.

TRIAL REGISTRATION:

ClinicalTrials.gov, ID: NCT03910712 . Registered on 10 Apr. 2019.

• Authors: Changjun Wang, Yan Lin, Yidong Zhou, Feng Mao, Hanjiang Zhu, Jinghong Guan, Xiaohui Zhang, Songjie Shen, Xin Huang, Chang Chen, Ru Yao, Jialin Zhao, Qiang Sun
• Journal: BMC cancer (BMC Cancer) Vol. 20 Issue 1 Pg. 653 (Jul 13 2020) ISSN: 1471-2407 [Electronic] England
• PMID: 32660609 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Acrylamides
• Aminoquinolines
• Androstadienes
• Receptors, Estrogen
• Receptors, Progesterone
• pyrotinib
• Anastrozole
• Letrozole
• ERBB2 protein, human
• Receptor, ErbB-2
• exemestane
• Trastuzumab

Topics

• Acrylamides (administration & dosage)
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Aminoquinolines (administration & dosage)
• Anastrozole (administration & dosage)
• Androstadienes (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Breast Neoplasms (drug therapy, metabolism, pathology)
• Female
• Follow-Up Studies
• Humans
• Letrozole (administration & dosage)
• Middle Aged
• Prognosis
• Prospective Studies
• Receptor, ErbB-2 (metabolism)
• Receptors, Estrogen (metabolism)
• Receptors, Progesterone (metabolism)
• Trastuzumab (administration & dosage)
• Young Adult