Clinical trial NCT06734533: Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive（HR+） Metastatic Breast Cancer(MBC) .
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HR+ Breast Cancer
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HR+ metastatic breast cancer previously treated with CDK4/6is

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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: through study completion, an average of 1 year
measure: Disease control rate (DCR)
timeFrame: through study completion, an average of 1 year
measure: Overall survival(OS)
timeFrame: through study completion, an average of 5 year
measure: Incidence of Treatment-Emergent Adverse Events (Safety)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincial Tumor Hospital
state: Hunan
Study officials:
References: