CAMELLIA
A Randomized Phase III Study of Metronomic vs. Intermittent Capecitabine Maintenance Therapy Following First-line Capecitabine and Docetaxel Therapy in HER2-negative Metastatic Breast Cancer
Sponsor study identifier
interventional
280
1 country
1
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast cancer(mBC).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
July 19, 2013
Actual (reported)August 6, 2013
Actual (reported)October 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Progression Free Survival (PFS)
Time from randomization to progression or death (whichever occurred first).
up to 36 months
Adverse events (AEs)
up to 36 months
Overall survival (OS):
up to 52 months
Overall Response rates (ORR)
Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle.
Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle
Eligible patients will receive treatment with Capecibatine (1000 mg/ m2 twice daily D1-14 Q3W) plus docetaxel(75 mg/m2, D1,Q3W) for a maximum of 6 cycles, or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration. For the the patients with SD, PR or CR after initiate treatment phrase will enter into maintenance treatment phase.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Docetaxel plus Capecitabine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordCancer Institute and Hospital, Chinese Academy Of Medical Sciences
Beijing, 100021, China
Yi Z, Feng K, Lv D, Guan Y, Shao Y, Ma F, Xu B. Genomic landscape of circulating tumor DNA in HER2-low metastatic breast cancer. Signal Transduct Target Ther. 2024 Dec 9;9(1):345. doi: 10.1038/s41392-024-02047-0.
Guan X, Ma F, Li C, Wu S, Hu S, Huang J, Sun X, Wang J, Luo Y, Cai R, Fan Y, Li Q, Chen S, Zhang P, Li Q, Xu B. The prognostic and therapeutic implications of circulating tumor cell phenotype detection based on epithelial-mesenchymal transition markers in the first-line chemotherapy of HER2-negative metastatic breast cancer. Cancer Commun (Lond). 2019 Jan 3;39(1):1. doi: 10.1186/s40880-018-0346-4.
Binghe Xu, MD, PhD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First Submitted
July 19, 2013
First Posted
August 6, 2013
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2020
up to 36 months
Clinical Benefit rate (CBR)
up to 36 months
Time to Progression (TTP)
up to 36 months
Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle
Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 23, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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