Status:
UNKNOWN
Anlotinib Combined With Chemotherapy for the Treatment of HER2 Negative Advanced Breast Cancer
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
HER2-negative Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The study is being conducted to evaluate the efficacy and safety of anlotinib combined with chemotherapy treatment for patients with HER2 negative advanced breast cancer previously received anthracycl...
Detailed Description
Breast cancer is the most frequent malignancy in women worldwide. Treatments on HER2 negative breast cancer are still under exploration. Therefore, it is imperative to find a novel therapy to treat th...
Eligibility Criteria
Inclusion
- Age ≥18 years old (calculated on the day of signing informed consent);
- Histologically diagnosed advanced breast cancer, including inoperable locally advanced breast cancer or recurrent/metastatic breast cancer;
- Immunohistochemical detection of HER-2 (-) or (1+), of which HER-2 (2+) must be tested by FISH and the result is negative;
- All patients have previously underwent chemotherapy containing anthracyclines and taxanes (adjuvant, neoadjuvant or rescue therapy) , and treatment failure or disease progression received at most two chemotherapy regimens after recurrence/metastasis. HR+/HER2- breast cancer patients need to complete endocrine drug therapy;
- Physical condition ECOG PS: 0-1;
- There is at least 1 measurable lesion of metastasis according to RECIST 1.1;
- The patients voluntarily joined the project and signed the informed consent.
Exclusion
- Pregnant or lactating women;
- Patients with a previous history of breast cancer were excluded, except for ipsilateral DCIS who received only local therapy ≥5 years ago; patients with a history of any other cancer (except non-melanoma skin cancer or cervical carcinoma in situ) were excluded;
- allergic to Anlotinib;
- Received eribulin, capecitabine treatment or anti-angiogenic drug treatment in the past;
- Uncontrolled brain metastases (except asymptomatic, or patients with stable brain metastases receiving local treatment);
- According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Key Trial Info
Start Date :
April 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT05334147
Start Date
April 15 2022
End Date
September 1 2025
Last Update
April 19 2022
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