Combining oral vinorelbine and anlotinib for HER2-negative metastatic breast cancer

Efficacy and Safety of Metronomic Oral Vinorelbine Plus Anlotinib in HER2-negative Metastatic Breast Cancer Patients

This study tests if a combination of two oral medications, vinorelbine and anlotinib, can help people with HER2-negative metastatic breast cancer when other treatments have not worked.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Xi'an International Medical Center Hospital (Academic / other)
• Drugs / interventions: anlotinib, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT06015126 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of a combination treatment using metronomic oral vinorelbine and anlotinib in patients with HER2-negative metastatic breast cancer. The study is designed as a single-center, open-label, single-arm trial with a planned enrollment of 60 patients. It aims to provide new data on treatment options for patients who have limited choices in later lines of therapy. The approach focuses on the convenience of oral administration and the potential synergistic effects of the two drugs.

Who should consider this trial

Good fit: Ideal candidates include females aged 18 and older with histologically confirmed HER2-negative metastatic breast cancer who have experienced disease progression after prior treatments.

Not a fit: Patients with HER2-positive breast cancer or those who have not yet received first-line treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with HER2-negative advanced breast cancer who have exhausted other therapies.

How similar studies have performed: While there have been studies on metronomic chemotherapy, this specific combination of oral vinorelbine and anlotinib in HER2-negative breast cancer is relatively novel.

Eligibility criteria

Inclusion Criteria：

* Voluntarily sign an informed consent form;
* Females aged 18 years or older;
* ECOG physical performance status score of 0-2;
* Histologically confirmed HER2-negative metastatic breast cancer patients, and patients with locally recurrent disease who cannot undergo curative surgery or radiation therapy;
* HR-positive/HER2-negative advanced breast cancer patients who have primary endocrine resistance or disease progression after first-line endocrine ± targeted therapy;
* Triple-negative advanced breast cancer patients with disease progression after first-line chemotherapy ± immunotherapy;
* Blood routine examination meets the following conditions: ①absolute neutrophil count (ANC) ≥1.5×10\^9/L, ② platelets ≥100×10\^9/L, ③ hemoglobin ≥90 g/L, ④ white blood cell count ≥3.0×10\^9/L;
* The liver function meets the following criteria: ① serum total bilirubin ≤ 1.5 × ULN, and if there is liver metastasis, it should be ≤ 3 × ULN; ② AST or ALT ≤ 3 × ULN, and if there is liver metastasis, it should be ≤ 5 × ULN;
* The renal function meets the following criteria: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (calculated according to the Cockroft-Gault formula);
* Female patients who meet the following criteria can participate in this study: ① Patients are not capable of reproduction; ② Patients have reproductive capacity, and have a negative result on the pregnancy test within 7 days before the first administration of the investigational drug, are not in the lactation period, and continuously adopt effective contraceptive measures before entering the study and during the entire study period and within 6 months after the last administration of the investigational drug.

Exclusion Criteria:

* Patients who have previously received treatment with vinorelbine and/or anlotinib;
* Patients with active or untreated brain metastasis;
* Patients who have had or currently have other malignancies within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades basement membrane)\];
* Patients who have undergone major surgery (including thoracotomy biopsy) or suffered a significant trauma (such as bone fracture) within 4 weeks before randomization, have unhealed wounds or fractures at the time of screening, or are expected to undergo major surgery during the study period;
* Patients with a history of myocardial infarction within the past 6 months; history of congestive heart failure with New York Heart Association (NYHA) classification ≥ II, or severe arrhythmia (excluding atrial fibrillation and paroxysmal supraventricular tachycardia) that cannot be controlled by medication;
* Patients with known allergies to the drugs and their excipients involved in this trial;
* Patients with a known history of hypersensitivity reactions to any investigational drugs;
* Patients who are simultaneously participating in other trials;
* Patients who cannot evaluate the efficacy of the treatment plan with existing technology;
* Patients judged unsuitable for participation by other investigators.

Where this trial is running

Xi'an, Shaanxi

• Xi'an International Medical Center Hospital — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Principal investigator: Yan Xue — Xi'an International Medical Center Hospital
• Study coordinator: Yan Xue

Conditions Breast Cancer