PLD-cyclophosphamide-Nab-P Continuously Combined With Dual HER2 Blockage for HER2-positive Breast Cancer

Phase 2

• Conditions: Breast Cancer; HER2-positive Breast Cancer
• Interventions: Drug: pegylated liposomal doxorubicin (PLD) plus cyclophosphamide followed by Nab-paclitaxel (Nab-P) ,continuously combined with dual HER2 blockage

• Registration Number: NCT05346107
• Lead Sponsor: Xijing Hospital

Brief Summary

patients with HER2-positive breast cancer (cT2-3/N0-1/M0) were treated with PldCHP (pegylated liposomal doxorubicin 35mg/m2, cyclophosphamide 600mg/m2, trastuzumab 8 mg/kg loading, then 6 mg/kg, pertuzumab 840 mg loading, then 420 mg, iv, q3w) for 4 cycles followed by Nab-PHP (Nab-Paclitaxel 260mg/m2, trastuzumab 6 mg/kg, pertuzumab 420 mg, iv, q3w) for 4 cycles

Detailed Description

Upon approval by the Medical Ethics Committee of Xijing Hospital, patients with HER2-positive breast cancer (cT2-3/N0-1/M0) receiving neoadjuvant therapy, were enrolled. The patients were treated with PldCHP (pegylated liposomal doxorubicin 35mg/m2, cyclophosphamide 600mg/m2, trastuzumab 8 mg/kg loading, then 6 mg/kg, pertuzumab 840 mg loading, then 420 mg, iv, q3w) for 4 cycles followed by Nab-PHP (Nab-Paclitaxel 260mg/m2, trastuzumab 6 mg/kg, pertuzumab 420 mg, iv, q3w) for 4 cycles, with strict monitoring of cardiotoxicity. The primary endpoint was pCR rate, and secondary endpoints were cardiac safety during neoadjuvant therapy.

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-23
• Last Update Submitted: 2022-04-23
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. HER2-positive breast cancer
2. cT2-3/N0-1/M0
3. aged18-80 years
4. receiving neoadjuvant therapy
5. ECOGPS score 0 or 1
6. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures
7. Adequate organ function

Exclusion Criteria

1. cardiac, hepatic, renal, or psychiatric disease history
2. History of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PldCHP---Nab-PHP	pegylated liposomal doxorubicin (PLD) plus cyclophosphamide followed by Nab-paclitaxel (Nab-P) ,continuously combined with dual HER2 blockage	he patients were treated with PldCHP (pegylated liposomal doxorubicin 35mg/m2, cyclophosphamide 600mg/m2, trastuzumab 8 mg/kg loading, then 6 mg/kg, pertuzumab 840 mg loading, then 420 mg, iv, q3w) for 4 cycles followed by Nab-PHP (Nab-Paclitaxel 260mg/m2, trastuzumab 6 mg/kg, pertuzumab 420 mg, iv, q3w) for 4 cycles, with strict monitoring of cardiotoxicity.

Primary Outcome Measures

Name	Time	Method
Rate of pathological complete response	At the end of Cycle 1 (each cycle is 14 days)	absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0)

Secondary Outcome Measures

Name	Time	Method
adverse effects	during the period of neadjuvant chemotherapy, an average of 14 days	Serious adverse effect occur within neoadjuvant chemotherapy

Trial Locations

Locations (1)

Xijing Hospital ， Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China