NCT05945368

A Trial of Eribulin in Combination With HP Neoadjuvant Therapy in Patients With for HER2-Positive BC

A Prospective, Single-arm, Phase II Trial of Eribulin in Combination With Trastuzumab and Pertuzumab for Neoadjuvant Therapy HER2-Positive Early or Locally Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the pathology complete response rate (pathology Complete Response, pCR) of eribulin combined with trastuzumab + pertuzumab in neoadjuvant therapy for HER-2 positive early or locally advanced breast cancer.

Detailed description

Breast cancer with positive HER-2 is sensitive to chemotherapy and targeted therapy, and double-target regimen containing trastuzumab and pertuzumab is the preferred regimen no matter in neoadjuvant, adjuvant or advanced first-line stage. A series of clinical studies have established the strong position of trastuzumab + pertuzumab in the neoadjuvant therapy of HER2-positive breast cancer, but it is still unclear which chemotherapy drugs have the best efficacy when combined with them. Eribulin mesylate is a potent microtubule inhibitor. It is used as a single agent for the treatment of locally relapsed or metastatic breast cancer that has been treated with at least two chemotherapy regimens in the past, because of its good therapeutic effect and small toxic side effects The role of advanced breast cancer treatment is increasingly prominent. Therefore, the investigators plan to conduct clinical studies to evaluate the efficacy and safety of Eribulin combined with trastuzumab and pertuzumab in neoadjuvant therapy for HER-2 positive breast cancer, so as to provide better treatment options for neoadjuvant chemotherapy for HER-2 positive breast cancer. The investigators expect that Erribulin combined with trastuzumab and pertuzumab can achieve comparable results. If the pCR rate in this study reaches 40%, follow-up randomized controlled studies will be considered.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin mesylate injection、Pertuzumab、Trastuzumab	* Eribulin mesylate, 1.4 mg /m², day 1 and day 8; * Trastuzumab, 8 mg/kg load dose in the first cycle and 6 mg/kg in each subsequent cycle on day 1; * Pertuzumab, 840 mg load dose in the first cycle and 420 mg in each subsequent cycle on day 1; There are four cycles in 21 days

Timeline

• Start date: 2022-02-25
• Primary completion: 2024-02-25
• Completion: 2025-02-25
• First posted: 2023-07-14
• Last updated: 2023-07-14

Locations

1 site across 1 country: China