Status:
COMPLETED
Comparison of TP and TAC Regimens in Neoadjuvant Treatment of TNBC
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Previous studies have shown that TNBC is sensitive to DNA crosslinking-related chemotherapeutic drugs such as platinum. However, there is a lack of large sample prospective clinical data to compare th...
Detailed Description
In this study, TNBC patients were randomly divided into experimental group and control group, the ratio of experimental group to control group was 1:1. The experimental group received 6 cycles of neoa...
Eligibility Criteria
Inclusion
- Age: 18-70.
- Clinical stage Ⅱ-Ⅲ.
- triple negative and invasive breast cancer confirmed by histopathology:
- Triple negative breast cancer is defined as:
- negative for ER and PR (IHC nuclear staining \< 10%).
- Her-2 negative (IHC 0,1 + without FISH, or IHC 2 + and without FISH amplification).
- With clinically measurable focus: Measurable lesions observed on ultrasound, mammography, or magnetic resonance imaging (optional) within the month prior to randomization.
- Organ and bone marrow function tests within 1 month before chemotherapy indicate no contraindications to chemotherapy:
- neutrophils count absolute value ≥ 2.0×109/L
- hemoglobin ≥ 100g/L
- blood platelet ≥ 100×109/L
- total bilirubin \< 1.5 ULN (upline of normal value)
- creatinine \< 1.5×ULN
- AST/ALT \< 1.5×ULN;
- Cardiac ultrasound EF value ≥ 55%.
- Females of childbearing age with negative serum pregnancy test 14 days before randomization.
- ECOG score ≤1.
- Sign informed consent.
Exclusion
- Evidence of metastatic breast cancer (excluding metastatic breast cancer, a chest CT, abdominal ultrasound, or CT and bone scanning should be performed at any time point before diagnosis and randomization; PET/CT scanning can be used as an alternative imaging examination mean) .
- The patients have received chemotherapy, endocrine therapy, targeted therapy, and radiation therapy for this disease.
- The patient has a second primary malignant tumor, except for:
- \- Thoroughly treated skin cancer
- Due to severe and uncontrollable other medical diseases, researchers believe the existence of chemotherapy contraindications.
Key Trial Info
Start Date :
November 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2022
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT04664972
Start Date
November 23 2018
End Date
November 26 2022
Last Update
September 20 2024
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008