An observational study in HER2-negative Breast Cancer, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-19.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational
The study is being conducted to evaluate the efficacy and safety of anlotinib combined with chemotherapy treatment for patients with HER2 negative advanced breast cancer previously received anthracyclines and taxanes
Breast cancer is the most frequent malignancy in women worldwide. Treatments on HER2 negative breast cancer are still under exploration. Therefore, it is imperative to find a novel therapy to treat these patients.
Anlotinib is an anti-angiogenic small-molecule butyrate kinase inhibitor, and preliminary phase II study results show that anlotinib has good efficacy and tolerability in the treatment of HER-2-negative advanced breast cancer.
This study is a prospective, multicenter, observational clinical study that will collect and report anlotinib in combination with anlotinib in patients with HER2-negative advanced breast cancer treated with anthracyclines and taxanes in a real-world clinical setting Efficacy and safety data for chemotherapy treatments.
The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 564 studies on the registry; 312 are open to participants now.
Counted across the registry records on this site, refreshed daily.
HER2 negative advanced breast cancer patients treated with anthracyclines and taxanes
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
anlotinib12mg qd p.o. d1-14/21day/cycle；eribulin 1.4 mg/m2，d1\&d8/21day/cycle；capecitabine 1000 mg/m2，bid，d1-14/21day/cycle.
eribulin 1.4 mg/m2，d1\&d8/21day/cycle；capecitabine 1000 mg/m2，bid，d1-14/21day/cycle.
Progression Free Survival (PFS)
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
Time frame: up to 1 year after the last patient enrolled
objective response rate（ORR）
The ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)
Time frame: up to 1 year after the last patient enrolled
Clinical benefit rate（CBR）
Proportion of patients with a complete response (CR), partial response (PR), and stable disease (SD) ≥24 weeks in the best objective tumor response
Time frame: up to 1 year after the last patient enrolled
overall survival（OS）
The time from the patient's initiation of treatment to death from any cause
Time frame: up to 1 year after the last patient enrolled
Incidence and Severity of adverse events
AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
Time frame: up to 1 year after the last patient enrolled
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University →