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Spots Global Cancer Trial Database for Pyrotinib Combined With Capecitabine Metronomic Therapy in HER2-postitive Advanced Breast Cancer

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Trial Identification

Brief Title: Pyrotinib Combined With Capecitabine Metronomic Therapy in HER2-postitive Advanced Breast Cancer

Official Title: Pyrotinib Combined With Capecitabine Metronomic Therapy in HER2-postitive Advanced Breast Cancer: Single Arm, Single Center, Phase II Clinical Trial.

Study ID: NCT03923166

Conditions

Breast Cancer

Study Description

Brief Summary: Overexpression of the HER2 gene accounts for 20% to 30% of breast cancer. Although trastuzumab combined with chemotherapy has become the basic treatment for patients with HER2-positive advanced breast cancer, For patients who have progressed or relapsed after trastuzumab treatment, There are still many issues to explore on the choice of program of retargeted therapy. In HER2-positive advanced breast cancer, the results of Phase I and Phase I/II trials of pyrotinib or pyrotinib combined with capecitabine show that the anti-tumor effect is rapid, efficient and sustainable, and the patient is safe and well tolerated. Capecitabine is an oral cytotoxic drug that has high selectivity and specificity against tumors. Many patients need to adjust the dose due to adverse reactions, especially for patients after multi-line treatment. Previous studies have shown that sustained low-dose capecitabine reduces the adverse effects of the drug while ensuring efficacy. Based on the above, this study is to conduct a single-center, one-arm phase II clinical trial to explore the efficacy and safety of pyrotinib and capecitabine in the treatment of HER2-positive advanced breast cancer.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China

Contact Details

Name: Qiao Li

Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Role: PRINCIPAL_INVESTIGATOR

Name: Binghe Xu

Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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