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

NCT05346107 | Unknown Phase 2

• 1 other identifier: KY20223267-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of pathological complete response

  absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0)

  At the end of Cycle 1 (each cycle is 14 days)

Secondary Outcomes (1)

• adverse effects

  during the period of neadjuvant chemotherapy, an average of 14 days

Study Arms (1)

PldCHP---Nab-PHP

EXPERIMENTAL

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.

Drug: pegylated liposomal doxorubicin (PLD) plus cyclophosphamide followed by Nab-paclitaxel (Nab-P) ,continuously combined with dual HER2 blockage

Interventions

pegylated liposomal doxorubicin (PLD) plus cyclophosphamide followed by Nab-paclitaxel (Nab-P) ,continuously combined with dual HER2 blockage DRUG

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.

PldCHP---Nab-PHP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• cardiac, hepatic, renal, or psychiatric disease history
• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital ， Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (1)

• Yang JX, Yang YQ, Hu WY, Yang L, Wu J, Wen XX, Yu J, Huang ML, Xu DD, Tie DC, Wang L, Li FF, Li NL. A Phase II Study of Neoadjuvant PLD/Cyclophosphamide and Sequential nab-Paclitaxel Plus Dual HER2 Blockade in HER2-Positive Breast Cancer. Oncologist. 2024 Jan 5;29(1):e15-e24. doi: 10.1093/oncolo/oyad160.

  PMID: 37279780 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicin; 1-dodecylpyridoxal

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Nan lin li

CONTACT

02984775271; linanlingo@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 26, 2022
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)