Clinical trial · Observational
Anlotinib Combined With Chemotherapy for the Treatment of HER2 Negative Advanced Breast Cancer
Anlotinib Combined With Chemotherapy for the Treatment of HER2 Negative Advanced Breast Cancer Previously Treated With Anthracyclines and Taxanes: A Multicenter, Prospective, Observational Clinical Study
NCT05334147CI-TRIAL-00057878ALOT-BC1unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 anthracyclines and taxanes
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Anlotinib in combination with chemotherapy
- description
- anlotinib12mg qd p.o. d1-14/21day/cycle;eribulin 1.4 mg/m2,d1\&d8/21day/cycle;capecitabine 1000 mg/m2,bid,d1-14/21day/cycle.
- label
- chemotherapy
- description
- eribulin 1.4 mg/m2,d1\&d8/21day/cycle;capecitabine 1000 mg/m2,bid,d1-14/21day/cycle.
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- up to 1 year after the last patient enrolled
- description
- PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
Secondary outcomes (4)
- measure
- objective response rate(ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years old (calculated on the day of signing informed consent); 2. Histologically diagnosed advanced breast cancer, including inoperable locally advanced breast cancer or recurrent/metastatic breast cancer; 3. Immunohistochemical detection of HER-2 (-) or (1+), of which HER-2 (2+) must be tested by FISH and the result is negative; 4. 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; 5. Physical condition ECOG PS: 0-1; 6. There is at least 1 measurable lesion of metastasis according to RECIST 1.1; 7. The patients voluntarily joined the project and signed the informed consent. Exclusion Criteria: 1. Pregnant or lactating women; 2. 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; 3. allergic to Anlotinib; 4. Received eribulin, capecitabine treatment or anti-angiogenic drug treatment in the past; 5. Uncontrolled brain metastases (except asymptomatic, or patients with stable brain metastases receiving local treatment); 6. 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.
References
Publications (5)
- BACKGROUNDGonzalez-Angulo AM, Morales-Vasquez F, Hortobagyi GN. Overview of resistance to systemic therapy in patients with breast cancer. Adv Exp Med Biol. 2007;608:1-22. doi: 10.1007/978-0-387-74039-3_1. PMID 17993229
- BACKGROUNDBanerjee S, Dowsett M, Ashworth A, Martin LA. Mechanisms of disease: angiogenesis and the management of breast cancer. Nat Clin Pract Oncol. 2007 Sep;4(9):536-50. doi: 10.1038/ncponc0905. PMID 17728712
- BACKGROUNDRanpura V, Hapani S, Wu S. Treatment-related mortality with bevacizumab in cancer patients: a meta-analysis. JAMA. 2011 Feb 2;305(5):487-94. doi: 10.1001/jama.2011.51. PMID 21285426
- BACKGROUNDMiller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007 Dec 27;357(26):2666-76. doi: 10.1056/NEJMoa072113. PMID 18160686
- RESULTHu N, Si Y, Yue J, Sun T, Wang X, Jia Z, Gao S, Li Q, Shao Y, Wang J, Luo Y, Ma F, Xu B, Yuan P. Anlotinib has good efficacy and low toxicity: a phase II study of anlotinib in pre-treated HER-2 negative metastatic breast cancer. Cancer Biol Med. 2021 Mar 12;18(3):849-59. doi: 10.20892/j.issn.2095-3941.2020.0463. PMID 33710812