Evidence map›Paper›PMID 37559142›Full record

Trial reportBMC medicine2023

Pyrotinib plus capecitabine for trastuzumab-resistant, HER2-positive advanced breast cancer (PICTURE): a single-arm, multicenter phase 2 trial.

Jun Cao, Yuee Teng, Huiping Li, Lili Zhang, Quchang Ouyang, Weimin Xie, Yueyin Pan, Zhenchuan Song, Xiaoling Ling, Xiaohong Wu and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04001621 (Phase II Study of Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04001621 phase2unknown statusnot on this map

Phase II Study of Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer

TypeinterventionalSponsorFudan UniversityRan2019 to 2023Enrolled100ConditionsMetastatic Breast CancerArmsPyrotinib combined with capecitabine
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

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  14. Recent advances in systematic therapy of breast cancer: Chinese contribution for international progress.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2024
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  17. Pyrotinib is effective in both trastuzumab-sensitive and primary resistant HER2-positive breast tumors.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 13 institutions in 1 country.

Jun Cao *Department of Breast and Urologic Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong'An Road, Shanghai, 200032, China.
Yuee Teng *Department of Medical Oncology, The First Hospital of China Medical University, 110001, Shenyang, China.
Huiping Li *Department of Medical Oncology, Peking University Cancer Hospital and Institute, Beijing, 100142, China.
Lili ZhangDepartment of Medical Oncology, Jiangsu Cancer Hospital, Nanjing, 210008, China.
Quchang OuyangDepartment of Medical Oncology, Hunan Cancer Hospital, Changsha, 410013, China.
Weimin XieDepartment of Medical Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530027, China.
Yueyin PanDepartment of Medical Oncology, The First Affiliated Hospital of USTC, Hefei, 230001, China.
Zhenchuan SongBreast Center, The Fourth Hospital of Hebei Medical University, 050011, Shijiazhuang, China.
Xiaoling LingDepartment of Medical Oncology, The First Hospital of Lanzhou University, Lanzhou, 730013, China.
Xiaohong WuDepartment of Medical Oncology, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China.
Jingwei XuDepartment of Breast Surgery, The Second Hospital of Jilin University, Changchun, 130041, China.
Li LiDepartment of Medical Oncology, Qilu Hospital of Shandong University, Jinan, 250012, China.
Liping RenDepartment of Breast Surgery, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Hong WangDepartment of Medical Oncology, The Third Hospital of Nanchang, Nanchang, 330008, China.
Dongxian ZhouDepartment of Breast Surgery, Shenzhen People's Hospital, Shenzhen, 518020, China.
Jing LuoDepartment of Breast Surgery, Sichuan Provincial People's Hospital, Chengdu, 610072, China.
Xichun HuDepartment of Breast and Urologic Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong'An Road, Shanghai, 200032, China. xchu2009@hotmail.com.
Fudan University Shanghai Cancer Center · CNChina Medical University · CNFirst Hospital of Lanzhou University · CNGuangxi Medical University · CNHebei Medical University · CNHunan Cancer Hospital · CNJiangnan University · CNJiangsu Cancer Hospital · CNPeking University · CNQilu Hospital of Shandong University · CNSecond Affiliated Hospital of Jilin University · CNShenZhen People’s Hospital · CNThird Hospital of Nanchang · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer and primary resistance to trastuzumab have a poor clinical outcome and lack good evidence to inform clinical decision. This study investigated the efficacy and safety of pyrotinib plus capecitabine in this population.

methodsThis phase 2 trial was conducted at 16 sites in China. Patients received oral pyrotinib 400 mg once daily and capecitabine 1000 mg/m

resultsBetween June 2019 and September 2021, 100 patients were enrolled with a median age of 51 years (range, 24-69). All patients had been treated with trastuzumab and 21 (21.0%) patients had prior use of pertuzumab. As of August 31, 2022, the median follow-up duration was 20.1 months (range, 1.3-38.2). The median PFS was 11.8 months (95% confidence interval [CI], 8.4-15.1), which crossed the pre-specified efficacy boundary of 8.0 months. The objective response rate was 70.0% (70/100), with a median duration of response of 13.8 months (95% CI, 10.2-19.3). The disease control rate was 87.0% (87/100). The median overall survival was not reached. The most common grade ≥ 3 treatment-emergent adverse event was diarrhea (24 [24.0%]). No treatment-related deaths occurred.

conclusionsPyrotinib plus capecitabine can be considered to be a treatment option in HER2-positive advanced breast cancer patients who have shown primary resistance to trastuzumab. Even in the era of modern anti-HER2 treatments, this clinical setting warrants more investigations to meet unmet needs.

trial registrationClinicalTrials.gov, NCT04001621. Retrospectively registered on June 28, 2019.

Indexed as

Breast NeoplasmsCapecitabineAcrylamidesAdultAgedAminoquinolinesAntineoplastic Combined Chemotherapy ProtocolsErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedTrastuzumabYoung AdultAcrylamidesAminoquinolinesCapecitabineErb-b2 Receptor Tyrosine KinasespyrotinibTrastuzumabBreast cancerCapecitabineHuman epidermal growth factor receptor 2PyrotinibTrastuzumab resistance

Identifiers

PMID37559142
PMCPMC10410905
OpenAlexW4385708137

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.