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

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

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.

NCT06734533•Hunan Cancer Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

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.

Locations (1)

Hunan Provincial Tumor Hospital

Changsha, Hunan, China

Key Dates

Start Date

December 5, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 30, 2025

Last Updated

December 16, 2024

Enrollment

ESTIMATED participants

Conditions

HR+ Breast Cancer

Interventions

Anlotinib+eribulin/nab-paclitaxel/etoposide/capecitabine/pembrolizumab/ sintilimab/ fulvestrant, etc

OTHER

Contacts

Quchang Ouyang

CONTACT

15676789890 tgzybc@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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