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Breast Neoplasms

Breast Diseases

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Capecitabine

Antimetabolites

Pyrotinib 400mg, qd, po, day 1-21, q3w, Capecitabine 1000mg/m2, bid po d1-14, q3w

pyrotinib combined with Capecitabine

treatment of physician's choice

Xuefei Wang

Xuefei Wang, Dr.

This is a prospective, multicenter, registry-based cohort study to explore the efficacy and safety of Pyrotinib combined with Capecitabine for adjuvant treatment of HER2 positive early breast cancer compared with treatment of physician's choice. Pyrotinib is a small molecule tyrosine kinase inhibitor which can irreversibly inhibit HER1, HER2, and HER4.

Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer

A Prospective, Multicenter and Registry-based Cohort Study of Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer

The 3-year IDFS (invasive disease-free survival) is defined as the time from the date of enrollment to the first occurrence of recurrent diseases. Recurrent diseases include ipsilateral or contralateral recurrent breast cancer, local or regional recurrence, remote recurrence and death caused by any reason. The observation period is from enrollment to 3 years after enrollment.

The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) are recorded according to the NCI CTCAE v5.0.

The quality of life (QoL) of the participants is assessed according to the EORTC QLQ-C30 quality of life questionnaire.

Peking Union Medical College Hospital

Professor

pyrotinib combined with capecitabine

Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer:

To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) To determine the dose-limiting toxicity (DLT) To determine the pharmacokinetic profile of Pyrotinib To assess preliminary antitumor activity To determine preliminary regimen dose for phase II study

Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer

A Phase I Study of Pyrotinib In Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer

DLT was difined as the cetain AEs which were observed during the first cycle (D1-D21）of treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer	NCT06035016	HER2-positive B... Early-stage Bre...	pyrotinib combi... treatment of ph...	18 Years - 75 Years	Peking Union Medical College Hospital
Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer	NCT06035016	HER2-positive B... Early-stage Bre...	pyrotinib combi... treatment of ph...	18 Years - 75 Years	Peking Union Medical College Hospital
Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer	NCT02361112	Metastatic Brea...	pyrotinib combi...	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.

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