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

NCT06015126 | Unknown

• 1 other identifier: Y-pierrefabre202102-0108
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

vinorelbine are one of the main chemotherapy drugs used in the treatment of advanced breast cancer. It is available in oral form, making it convenient to use and an ideal choice for rhythmic chemotherapy. In advanced breast cancer,metronomic oral vinorelbine chemotherapy has been the subject of several clinical studies, with proven effectiveness and good safety, showing great prospects for application. Considering the current lack of targeted, efficient, and convenient drugs for HER2-negative advanced breast cancer in later lines of treatment, and based on the preliminary efficacy of metronomic oral vinorelbine, anlotinib, and rhythmic chemotherapy in breast cancer, we plan to explore the efficacy and safety of combining metronomic oral vinorelbine chemotherapy with anlotinib in the treatment of HER2-negative advanced breast cancer, providing new data for the treatment of HER2-negative advanced breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  It is an indicator of the long-term efficacy of the drug.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (3)

• Objective Response Rate

  4 weeks

• Disease Control Rate

  4 weeks

• Overall survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (1)

Label 1

EXPERIMENTAL

metronomic oral vinorelbine plus anlotinib

Drug: metronomic oral vinorelbine plus anlotinib

Interventions

metronomic oral vinorelbine plus anlotinib DRUG

To clarify the efficacy and safety of metronomic oral vinorelbine plus anlotinib in HER2-negative metastatic breast cancer patients, adding new data for the posterior treatment of HER2-negative advanced breast cancer

Label 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yan Xue: lead

Study Sites (1)

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, 710100, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yan Xue

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Xue

CONTACT

0086-13992830596; 1410605462@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of tumor hospital

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 29, 2023
• Study Start: October 5, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

CN (1)