NCT04258163|CompletedDMCFDA Drug
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Sponsor study identifier
observational
760
1 country
3
Study Start
January 1, 2019
Actual (reported)Primary Completion
June 1, 2019
Actual (reported)Study Completion
July 1, 2019
Actual (reported)To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic breast cancer (MBC).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)June 1, 2019
Actual (reported)July 1, 2019
Actual (reported)February 4, 2020
Actual (reported)February 6, 2020
Actual (reported)Overall Survival (OS)
From enrollment to death (for any reason)
Estimated 36 months
Progression free survival (PFS)
Estimated 18 months
People who received chemotherapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
People who received endocrine therapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
People who didn't receive any maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks.
1000-1250 mg/m 2 PO twice daily days 1-14, cycled every 28 days
50 mg/m 2 IV day 1, cycled every 28 days
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Liposomal doxorubicin
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordThis is a multi-center real world study to compare maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and observation in patients with HR-positive MBC who achieved disease control after first-line chemotherapy. Patients were retrospectively enrolled from 3 different medical center.
First People's Hospital of Foshan
Foshan, Guangdong, China
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
Ren W, Yu Y, Hong H, Wang Y, Gao Q, Chen Y, Chen P, Zhao J, Ou Q, Lin D, Fu T, Tan Y, Li C, Xie X, Ye G, Tang J, Yao H. Clinical Evidence of Chemotherapy or Endocrine Therapy Maintenance in Patients with Metastatic Breast Cancer: Meta-Analysis of Randomized Clinical Trials and Propensity Score Matching of Multicenter Cohort Study. Cancer Res Treat. 2022 Oct;54(4):1038-1052. doi: 10.4143/crt.2021.698. Epub 2022 Feb 4.
Herui Yao, PhD
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
760 participants (actual enrollment reported by the registry).
First Submitted
February 4, 2020
First Posted
February 6, 2020
Study Start
January 1, 2019
Actual (reported)Pyrotinib Combined With Docetaxel in the First-line Treatment of HER2-positive MBC
800-1200 mg/m 2 IV days 1, 8, and 15, cycled every 28 days
500mg IH Days 0, 14, 28, then every 28 days
1mg PO qd
2.5mg PO qd
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2019
Actual (reported)Study Completion
July 1, 2019
Actual (reported)Last Updated
February 10, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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