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

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ClinicalTrials.gov Identifier: NCT06015126
Recruitment Status : Recruiting
First Posted : August 29, 2023
Last Update Posted : August 29, 2023
Sponsor:
Information provided by (Responsible Party):
Yan Xue, Xi'an International Medical Center Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: metronomic oral vinorelbine plus anlotinib Not Applicable

Detailed Description:

Research Title A single-center, open-label, single-arm clinical study on the efficacy and safety of Changchun Ruibin rhythmic chemotherapy combined with anlotinib in HER2-negative advanced breast cancer.

Study Drugs - metronomic oral vinorelbine: 30mg/capsule, 20mg/capsule - Anlotinib: 12mg/capsule, 10mg/capsule, 8mg/capsule

Research Objective To determine the efficacy and safety of metronomic oral vinorelbine chemotherapy combined with anlotinib in the treatment of HER2-negative advanced breast cancer, and to provide new data for later-line treatment of HER2-negative advanced breast cancer.

Study Design A single-center, open-label, single-arm clinical study with a planned enrollment of 60 patients.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Metronomic Oral Vinorelbine Plus Anlotinib in HER2-negative Metastatic Breast Cancer Patients
Actual Study Start Date : October 5, 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Label 1
metronomic oral vinorelbine plus anlotinib
 Drug: metronomic oral vinorelbine plus anlotinib
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


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 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 ]
    It is an indicator of the long-term efficacy of the drug.


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 4 weeks ]
    The proportion of patients with the best response of complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST).

  2. Disease Control Rate [ Time Frame: 4 weeks ]
    The proportion of patients with tumor shrinkage or stability maintained for a certain period, including cases of CR, PR, and stable disease (SD).

  3. Overall survival [ Time Frame: 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 ]
    It is an indicator of the long-term efficacy of the drug.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06015126


Contacts
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Contact: Yan Xue 0086-13992830596 1410605462@qq.com

Locations
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China, Shaanxi
Xi'an International Medical Center Hospital Recruiting
Xi'an, Shaanxi, China, 710100
Contact: Yan Xue    0086-13992830596    1410605462@qq.com   
Sponsors and Collaborators
Yan Xue
Investigators
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Principal Investigator: Yan Xue Xi'an International Medical Center Hospital
More Information
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Responsible Party: Yan Xue, Director of tumor hospital, Xi'an International Medical Center Hospital
ClinicalTrials.gov Identifier: NCT06015126    
Other Study ID Numbers: Y-pierrefabre202102-0108
First Posted: August 29, 2023    Key Record Dates
Last Update Posted: August 29, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action