NCT06734533 Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive（HR+） Metastatic Breast Cancer(MBC) .
| NCT ID | NCT06734533 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hunan Cancer Hospital |
| Condition | HR+ Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-12-05 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06734533 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying HR+ Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06734533 currently recruiting?
Yes, NCT06734533 is actively recruiting participants. Contact the research team at tgzybc@163.com for enrollment information.
Where is the NCT06734533 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06734533 clinical trial?
NCT06734533 is sponsored by Hunan Cancer Hospital. The trial plans to enroll 80 participants.
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