Palbociclib, trastuzumab, pyrotinib and fulvestrant in patients with brain metastasis from ER/PR positive, HER-2 positive breast cancer: Report from an interim analysis of a multicenter, prospective study in China.

Authors

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Ruoxi Hong

Department of Medical Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, China

Ruoxi Hong , Fei Xu , Yongkui Lu , Caiwen Du , Zhongyu Yuan , Yanxia Shi , Wen Xia , Shusen Wang

Organizations

Department of Medical Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, China, Sun Yat-Sen University Cancer Center, Guangzhou, China, Affiliated cancer hospital of Guangxi Medical University, Guangxi, China, Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, Longgang District, China, Sun Yat-sen University Cancer Center (China), Guangzhou, China, Sun yat-sen University Cancer Center, Guangzhou, China, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong Province, China

Research Funding

Pharmaceutical/Biotech Company
Pfizer Global Medical Grants (55593617)

Background: HER2-positive breast cancer patients are at a high risk of developing metastases in brain. Effective treatment should involve anti-HER2 targeted therapy. This aim of this study is to evaluate the activity of the chemo-free combination of palbociclib, trastuzumab and pyrotinib with fulvestrant in ER positive, HER2-positive breast cancer patients with brain metastasis. Methods: We did a multi-center, prospective trial in three hospitals in China. Female patients older than 18 years who had whole brain radiotherapy-naive ER/PR positive, HER2-positive brain metastases with an Eastern Cooperative Oncology Group performance status of 0–2 were treated with palbociclib, fulvestrant, combined with trastuzumab and pyrotinib, and until disease progression or intolerable adverse effects. The primary endpoint was objective response rate in the central nervous system (CNS), as assessed by investigator per the modified Response Evaluation Criteria In Solid Tumours (version 1.1). The study is still ongoing and recruiting. Here we report the results of an interim analysis. The study is registered with ClinicalTrials.gov, NCT04334330. Results: Between December 4, 2020 and November 2, 2022, 15 patients were enrolled. Eleven patients had prior exposure to trastuzumab. In the 14 patients who were evaluable for clinical response, the objective response rate in the CNS was 28.6%? (95% CI, 8.4% - 58.1%). At a median follow-up of 6.3 months (range, 2.1-14.3 months), the median PFS was 10.6 months (95%CI, 4.3 – 16.9 months). The time to progression in the CNS was 8.5 months (95%CI, 5.9 – 11.1 months). Conclusions: Combination of palbociclib, trastuzumab and pyrotinib with fulvestrant represents an active chemo-free treatment strategy in hormonal receptor positive, HER2-positive breast cancer patients with brain metastasis. Clinical trial information: NCT04334330.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Breast Cancer—Metastatic

Track

Breast Cancer

Sub Track

HER2-Positive

Clinical Trial Registration Number

NCT04334330

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr e13032)

DOI

10.1200/JCO.2023.41.16_suppl.e13032

Abstract #

e13032

Abstract Disclosures