Hunan Provincial Tumor Hospital
Changsha, Hunan, China
Location status: Recruiting
NCT Number: NCT06734533
Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER-2)-negative metastatic breast cancer (MBC). However, the optimal treatment after progression on CDK4/6 inhibitors remains unknown. Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. This study aimed to evaluate the safety and efficacy of anlotinib-based combination therapy in patients with HR+ MBC previously treated with a CDK4/6 inhibitor.
Interested in participating?
Request Info18 year–75 year
Female
Observational
Changsha, Hunan, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Anlotinib (8/10/12 mg daily, Day 1-14 of each cycle) was administered orally to fasting patients, with dose reductions to 10 mg or 8 mg in cases of intolerable toxicity. Combination agents included eribulin, nab-paclitaxel, etoposide, capecitabine, pembrolizumab, sintilimab, or fulvestrant, among others.
Time frame: through study completion, an average of 1 year
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Time frame: through study completion, an average of 1 year
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: through study completion, an average of 1 year
The DCR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) or partial response (PR) or stable disease (SD).
Time frame: through study completion, an average of 5 year
OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
Time frame: through study completion, an average of 1 year
All the treatment-related adverse events occurred as assessed by CTCAE v4.0
Contact information is provided by the study sponsor or research team.
Hunan Cancer Hospital
Other
A New Option for Post-CDK4/6is Resistance Era: Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4/6is.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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