To hear about similar clinical trials, please enter your email below
Trial Title:
Short-course Trastuzumab, Pertuzumab With Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer
NCT ID:
NCT05891561
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Pertuzumab
Conditions: Keywords:
breast cancer
pertuzumab
her2
adjuvant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pertuzumab
Description:
4 cycles of taxane, pertuzumab, trastuzumab
Arm group label:
Pertuzumab
Summary:
The investigators 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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaosong Chen
Phone:
+8621-64370045*602102
Contact backup:
Last name:
Yiwei Tong
Phone:
+8621-64370045*602107
Start date:
November 1, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05891561
