PLD-cyclophosphamide-Nab-P Continuously Combined With Dual HER2 Blockage for HER2-positive Breast Cancer
Primary Purpose
Breast Cancer, HER2-positive Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
pegylated liposomal doxorubicin (PLD) plus cyclophosphamide followed by Nab-paclitaxel (Nab-P) ,continuously combined with dual HER2 blockage
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Xijing Hospital , Fourth Military Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PldCHP---Nab-PHP
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
adverse effects
Serious adverse effect occur within neoadjuvant chemotherapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05346107
Brief Title
PLD-cyclophosphamide-Nab-P Continuously Combined With Dual HER2 Blockage for HER2-positive Breast Cancer
Official Title
PLD Plus Cyclophosphamide Followed by Nab-paclitaxel (Nab-P) as Primary Chemotherapy Continuously Combined With Dual HER2 Blockage for HER2-positive Breast Cancer: A Single-arm Phase 2 Trial(Brecan Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, HER2-positive Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PldCHP---Nab-PHP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin (PLD) plus cyclophosphamide followed by Nab-paclitaxel (Nab-P) ,continuously combined with dual HER2 blockage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of pathological complete response
Description
absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0)
Time Frame
At the end of Cycle 1 (each cycle is 14 days)
Secondary Outcome Measure Information:
Title
adverse effects
Description
Serious adverse effect occur within neoadjuvant chemotherapy
Time Frame
during the period of neadjuvant chemotherapy, an average of 14 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan lin li
Phone
02984775271
Email
linanlingo@126.com
Facility Information:
Facility Name
Xijing Hospital , Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nanlin Li, Ph.D
Phone
+86-186-2963-7041
Email
nanlin-74@163.com
First Name & Middle Initial & Last Name & Degree
Hongyu Xiao, Master
Phone
+86-186-2963-7040
Email
louch2008@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PLD-cyclophosphamide-Nab-P Continuously Combined With Dual HER2 Blockage for HER2-positive Breast Cancer
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