Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive（HR+） Metastatic Breast Cancer(MBC) .

Recruiting

• Conditions: HR+ Breast Cancer

• Registration Number: NCT06734533
• Lead Sponsor: Hunan Cancer Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-03
• Status Verified: 2024-12
• Study Start: 2024-12-05
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Female patients aged 18 to 75 years, with an ECOG score of 0-1, and an expected survival of at least 3 months;
• Presence of measurable lesions as defined by RECIST 1.1 criteria;
• Histopathologically confirmed HR-positive/HER2-negative breast cancer. HER2 negativity is determined by an immunohistochemistry (IHC) result of HER2 (0/1+). If the result is HER2 (++), a FISH or CISH test is required to confirm the absence of HER2 amplification;
• Patients who have undergone multiple lines of advanced therapy with no remaining standard treatment options;
• Prior treatment with at least one line of CDK4/6 inhibitors and endocrine therapy;
• Disease progression following aromatase inhibitor (AI) or fulvestrant combined with CDK4/6 inhibitors, either as adjuvant therapy or as systemic treatment for advanced disease.

Exclusion Criteria

• Patients with HER2-positive breast cancer confirmed by histology or cytology;
• Patients who discontinued therapy due to non-disease progression reasons, such as adverse events or other non-medical factors;
• Detection of a second primary malignant tumor at the time of enrollment;
• Failure to complete CDK4/6 inhibitor therapy;
• Pregnant or breastfeeding patients;
• Presence of third-space fluid accumulation (e.g., pleural effusion, ascites, pericardial effusion) that cannot be managed through drainage or other methods;
• Patients previously treated with anti-angiogenic agents, including small molecules such as anlotinib or apatinib, and large molecules such as bevacizumab;
• Patients currently receiving any other anti-tumor treatment for any other malignancies.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	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.

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	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).
Objective response rate (ORR)	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)
Overall survival(OS)	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.
Incidence of Treatment-Emergent Adverse Events (Safety)	through study completion, an average of 1 year	All the treatment-related adverse events occurred as assessed by CTCAE v4.0

Trial Locations

Locations (1)

Hunan Provincial Tumor Hospital; 🇨🇳 Changsha, Hunan, China