Combining Anlotinib with Chemotherapy for HER2-negative Breast Cancer

Anlotinib Plus Chemotherapy as Neoadjuvant Treatment of High-risk, Early-stage Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer: A Prospective, Single-arm, Single-center, Phase II Clinical Study

This study is testing if adding a new drug called Anlotinib to standard chemotherapy can help people with hormone receptor-positive HER2-negative breast cancer respond better to treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Xijing Hospital (other)
• Drugs / interventions: chemotherapy, Anlotinib, cyclophosphamide
• Locations: 1 site (Xi'an, Shannxi Province)
• Trial ID: NCT05558722 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the efficacy and safety of adding Anlotinib, a multi-targeted tyrosine kinase inhibitor, to standard neoadjuvant chemotherapy in patients with hormone receptor-positive HER2-negative breast cancer. Participants aged 18 and older with untreated stage IIB-IIIA breast cancer will receive a regimen that includes Anlotinib alongside chemotherapy drugs such as pirarubicin and cyclophosphamide. The primary goal is to achieve a pathologic complete response, while secondary objectives include assessing safety and disease-free survival. The study aims to improve treatment outcomes for this specific breast cancer population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with untreated stage IIB-IIIA HER2-negative breast cancer.

Not a fit: Patients who have previously received anti-angiogenesis targeted drug therapy or have significant cardiovascular issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment effectiveness and improve survival rates for patients with HER2-negative breast cancer.

How similar studies have performed: Other studies have shown promise in combining anti-angiogenic therapies with chemotherapy for breast cancer, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* All patients were HER2 negative, defi ned as munohistochemistry of 0/1+, or if 2+, fl uorescence insitu hybridisation showed no evidence of amplifi cation of the HER2 gene.
* Patients were required to have a palpable primary tumor at least 2.0 cm in diameter in the breast, as assessed by physical examination, and to be classified as having tumor stage T1c to T3, nodal stage N0 to N2a, and metastasis stage M0.
* Other eligibility criteria adequate cardiac function (left ventricular ejection fraction within the normal institutional range, as assessed by multiplegated acquisition scan or echocardiogram), adequate bone marrow, hepatic, and renal function, and appropriate Eastern Cooperative Oncology Group (ECOG) performance status (0-2).
* All patients provided written informed consent.

Exclusion Criteria:

* Previously received anti-angiogenesis targeted drug therapy.
* patients have previous diagnosis of ischaemic heart disease, cerebrovascular disease, peripheral vascular disease, arterial or venous thromboembolic disease, cardiac failure, gastroduodenal ulcer, symptomatic diverticulitis, or inflammatory bowel disease.
* Previously received chemotherapy, radiotherapy, or endocrine therapy as treatment for breast cancer was allowed.
* No uncont rolled hypertension.

Where this trial is running

Xi'an, Shannxi Province

• Xijing Hospital Affiliated to Air Force Military Medical University — Xi'an, Shannxi Province, China (RECRUITING)

Study contacts

• Principal investigator: Ting Wang, PhD — Xijing Hospital Affiliated to Air Force Military Medical University
• Study coordinator: Ting Wang, PhD

Conditions: Breast Cancer Stage II, Breast cancer Antivascular drugs Neoadjuvant therapy