Combining Apatinib with CDK4/6 Inhibitor and Endocrine Therapy for Advanced Breast Cancer

Apatinib in Combination With CDK4/6 Inhibitor and Endocrine Therapy as the First-line Therapy for HR+/ HER2-Advanced Breast Cancer

This study is testing if a new combination of medications can help people with a specific type of advanced breast cancer feel better and improve their treatment outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 145 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Fudan University (other)
• Drugs / interventions: chemotherapy, immunotherapy, Apatinib
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05759572 on ClinicalTrials.gov

What this trial studies

This phase II clinical study aims to evaluate the efficacy of Apatinib in combination with a CDK4/6 inhibitor and endocrine therapy for patients with HR+/HER2- advanced breast cancer, specifically targeting the SNF4 subtype. Patients will be enrolled based on histological confirmation of their cancer subtype by the Department of Pathology at Fudan University Affiliated Cancer Hospital. The study is designed as an open-label trial, with the goal of preparing for larger randomized controlled phase III studies in the future.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 to 75 with histologically confirmed HR+/HER2- invasive breast cancer of the SNF4 subtype.

Not a fit: Patients with HER2 positive breast cancer or those who do not meet the specific subtype criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new effective treatment option for patients with HR+/HER2- advanced breast cancer.

How similar studies have performed: Other studies have shown promise with similar combinations of targeted therapies in breast cancer, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Females ≥18 years and ≤ 75 years old;
* Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER\> 10% tumor cell positive is defined as ER positive, PR\> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative);
* Subtype of similarity network fusion-4 (SNF-4) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital • Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer;
* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions;
* Has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /L; platelet count \> 75x10ˆ9 /L, hemoglobin \> 9g/dL;
* Patients had received no previous chemotherapy or targeted therapy for metastatic disease

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* Has adequate liver function and kidney function: serum creatinine
* ECOG score ≤ 2 and life expectancy ≥ 3 months;
* Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up

Exclusion Criteria:

* Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease
* Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms);
* Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months);
* is pregnant or breast feeding;
* Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).

Where this trial is running

Shanghai, Shanghai Municipality

• Breast cancer institute of Fudan University Cancer Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Zhimin Shao

Conditions: Breast Cancer Metastatic, first-line therapy