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Short-course Trastuzumab, Pertuzumab With Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pertuzumab
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, pertuzumab, her2, adjuvant

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Histologically diagnosed unilateral primary invasive breast cancer patient with pT1, pN0, and M0 disease HER2-positive, ie. immunohistochemistry [IHC] 3+ or IHC 2+ and fluorescence in situ hybridisation [FISH]-positive according to ASCO/CAP 2018 guidelines complete clinical pathological information Eastern Cooperative oncology Group [ECOG] 0-1 Currently not pregnant or breast-feeding Fine organ function Have good compliance with planned treatment, understand the study process and sign a written informed consent Exclusion Criteria: Bilateral or metastatic breast cancer Receiving neoadjuvant treatment Other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer Severe systemic infections or other serious illnesses HIV infection, active hepatitis B or C infection Known allergy to or intolerance to a therapeutic drug or its excipients Prior history of chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason Enrollment of another investigational study within 4 weeks prior to initial administration of the investigational treatment Receiving live vaccine within 30 days prior to initial administration of the investigational treatment History of mental illness or drug abuse that may affect compliance with the trial requirements The researchers determine that the patients were not suitable for the study

Sites / Locations

  • Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pertuzumab

Arm Description

4 cycles of taxane, Pertuzumab, Trastuzumab

Outcomes

Primary Outcome Measures

Disease free survival [DFS]
Time from surgery to first proven loco-regional recurrence, distant recurrence, second non-breast malignancy, or death from any cause

Secondary Outcome Measures

Overall survival [OS]
Time from surgery to death from any cause
Distant disease-free survival [DDFS]
Time from surgery to first proven distant recurrence, second non-breast malignancy, or death from any cause
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Full Information

First Posted
May 21, 2023
Last Updated
June 4, 2023
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05891561
Brief Title
Short-course Trastuzumab, Pertuzumab With Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer
Official Title
Short-course Trastuzumab, Pertuzumab Combined With Taxanes in the Adjuvant Treatment of Early Human Epidermal Growth Factor Receptor 2-positive Breast Cancer: an Open-label, Single-arm Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

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
We plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore whether 4 courses of dual HER2 blockade combined with taxanes can lead to a similar prognosis with current standard treatment, which is one-year trastuzumab monotherapy combined with chemotherapy, while reducing the adverse reactions of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, pertuzumab, her2, adjuvant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pertuzumab
Arm Type
Experimental
Arm Description
4 cycles of taxane, Pertuzumab, Trastuzumab
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Intervention Description
4 cycles of taxane, pertuzumab, trastuzumab
Primary Outcome Measure Information:
Title
Disease free survival [DFS]
Description
Time from surgery to first proven loco-regional recurrence, distant recurrence, second non-breast malignancy, or death from any cause
Time Frame
3 year
Secondary Outcome Measure Information:
Title
Overall survival [OS]
Description
Time from surgery to death from any cause
Time Frame
3 year
Title
Distant disease-free survival [DDFS]
Description
Time from surgery to first proven distant recurrence, second non-breast malignancy, or death from any cause
Time Frame
3 year
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
3 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically diagnosed unilateral primary invasive breast cancer patient with pT1, pN0, and M0 disease HER2-positive, ie. immunohistochemistry [IHC] 3+ or IHC 2+ and fluorescence in situ hybridisation [FISH]-positive according to ASCO/CAP 2018 guidelines complete clinical pathological information Eastern Cooperative oncology Group [ECOG] 0-1 Currently not pregnant or breast-feeding Fine organ function Have good compliance with planned treatment, understand the study process and sign a written informed consent Exclusion Criteria: Bilateral or metastatic breast cancer Receiving neoadjuvant treatment Other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer Severe systemic infections or other serious illnesses HIV infection, active hepatitis B or C infection Known allergy to or intolerance to a therapeutic drug or its excipients Prior history of chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason Enrollment of another investigational study within 4 weeks prior to initial administration of the investigational treatment Receiving live vaccine within 30 days prior to initial administration of the investigational treatment History of mental illness or drug abuse that may affect compliance with the trial requirements The researchers determine that the patients were not suitable for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaosong Chen
Phone
+8621-64370045*602102
Email
chenxiaosong0156@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yiwei Tong
Phone
+8621-64370045*602107
Email
ash_yiwei@sjtu.edu.cn
Facility Information:
Facility Name
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaosong Chen
Phone
+8621-64370045*602102
First Name & Middle Initial & Last Name & Degree
Yiwei Tong
Phone
+8621-64370045*602107

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Short-course Trastuzumab, Pertuzumab With Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer

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