Combining Inetetamab with Chemotherapy and Aromatase Inhibitors for Advanced Breast Cancer

A Phase II Single-arm Clinical Trial of the Efficacy and Tolerability of Inetetamab Combined With Cyclophosphamide Metronomic Chemotherapy and Aromatase Inhibitor in Metastatic HER2+/HR+ Breast Cancer

This study is testing if a new treatment combining Inetetamab with chemotherapy and hormone therapy can help people with advanced HER2-positive breast cancer who haven't responded to previous treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: trastuzumab, Inetetamab, cyclophosphamide, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04941885 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of Inetetamab, an anti-HER2 monoclonal antibody, in combination with cyclophosphamide metronomic chemotherapy and aromatase inhibitors for patients with metastatic HER2-positive and HR-positive breast cancer. The approach aims to enhance the antibody-dependent cell-mediated cytotoxicity (ADCC) effects of Inetetamab, which has shown promising pre-clinical results. Participants will be monitored for clinical benefits and potential mechanisms of action. The study is designed for patients who have experienced treatment failure with aromatase inhibitors and are in a state of disease progression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with metastatic HER2-positive and HR-positive breast cancer who have failed previous aromatase inhibitor treatments.

Not a fit: Patients with HER2-negative breast cancer or those who are not in a state of disease progression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced breast cancer who have limited treatment alternatives.

How similar studies have performed: Previous studies have indicated that combining metronomic chemotherapy with targeted therapies can lead to improved outcomes, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign the informed consent form;
2. 18-75 years old;
3. The expected survival period is ≥12 weeks;
4. Eastern Cooperative Oncology Group (ECOG) score \[0-2\] points;
5. The diagnosis of invasive carcinoma by histology or cytology; Estrogen receptor (ER) positive (defined as \>1% nuclear ER staining); HER2 negative (defined as IHC 0 or 1+, or HER2(2+) with HER2 FISH detection no amplification);
6. Inoperable or recurrent/metastatic breast cancer patients with aromatase inhibitor treatment failure;
7. In the state of disease progression before enrollment;
8. Measurable disease according to RECIST version 1.1 or only bone metastasis;
9. Adequate hematological, hepatic and renal function;
10. NYHA class I or II and Left ventricular ejection fraction (LVEF) ≥50%.
11. The diagnosis of invasive carcinoma by histology or cytology: Hormone receptor (HR) positive (defined as \>1% nuclear estrogen receptor staining); HER2 positive (defined as IHC 3+, or HER2 FISH detection amplification);
12. In the state of disease progression before enrollment;
13. Have lesions able to and agree to perform tissue biopsy at the time requested in the study;
14. Treatment ≥1 line after recurrence/metastasis, or relapse within 12 months after completing trastuzumab-based adjuvant therapy or during trastuzumab adjuvant therapy;
15. Previously received trastuzumab for anti-HER2 therapy;
16. Measurable disease according to RECIST version 1.1.

Exclusion Criteria:

1. Allergic to the ingredients of Inetetamab, cyclophosphamide or similar drugs;
2. Concomitant diseases/conditions that is not controllable, and any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study;
3. Patients who cannot accept drugs orally;
4. Women who are pregnant or breastfeeding or planning to give birth;
5. Patients with currently symptomatic brain or meningeal metastasis;
6. History of other primary malignancy;
7. Resistant to steroidal or nonsteroidal aromatase Inhibitor;
8. Have used Inetetamab;
9. Patients with life-threatening, symptomatic, metastatic visceral disease.

Where this trial is running

Guangzhou, Guangdong

• Shusen Wang — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Shusen Wang, MD — Sun Yat-sen University
• Study coordinator: Shusen Wang, MD

Conditions Breast Cancer