Triple Negative Breast Cancer Clinical Trial
Official title:
Comparing TP (Docetaxel + Cisplatin) and TAC (Docetaxel + Doxorubicin + Cyclophosphamide) in Neoadjuvant Therapy for Operable Triple Negative Breast Cancer, A Multicenter, Randomized, Phase II Clinical Trial
Verified date | April 2024 |
Source | Henan Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 the efficacy of TP and EC-T / TEC regimen in the neoadjuvant chemotherapy of TNBC. Besides, the application of anthracycline drugs is limited to a certain extent due to the cardiotoxicity. Based on the above evidence, the researchers hope to explore a more effective and safer new adjuvant therapy for TNBC.
Status | Completed |
Enrollment | 212 |
Est. completion date | November 26, 2022 |
Est. primary completion date | November 26, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Age: 18-70. 2. Clinical T2-T4c, or T1c with axillary LN+. 3. 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 FISH without amplification). 4. Clinically evaluable lesions: The presence of lesions that could be evaluated by ultrasound, molybdenum target or magnetic resonance imaging (optional) was within 1 month before randomization. 5. The function examination of organs/bone marrow showed no contraindication within 1 month before chemotherapy. - The absolute value of neutrophil count =2.0 × 109 / L. - The value of hemoglobin =100g/L. - Platelet count =100 × 109/L. - Total bilirubin < 1.5 ULN (normal value online). - Creatinine < 1.5 × ULN. - AST/ALT < 1.5 × ULN. 6. The EF value of echocardiography=55%. 7. The serum pregnancy test was negative for fertile woman within 14 days before randomization.. 8. KPS score=80. 9. Informed consent. Exclusion Criteria: 1. Metastatic breast cancer. 2. Before entering the clinical trial, patients had received chemotherapy, endocrine therapy, targeted therapy, radiotherapy and so on. 3. The patient had dual primary malignancies, except for skin cancer, which was treated. 4. Combined with other serious and uncontrollable medical diseases, the researchers judged that the disease had chemotherapy contraindications. |
Country | Name | City | State |
---|---|---|---|
China | Henan Cancer Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Henan Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The pathological complete remission rate (pCR rate) | It means that there is no invasive cancer (i.e. ypT0/is, ypN0) in the resected specimens (breast + armpit) after operation | Immediately after surgery | |
Secondary | Event free survival rate (EFS) | Time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or remote recurrence, second primary malignant tumor (breast cancer or other cancers) or death from any cause. | 5 years after surgery | |
Secondary | Objective response rate | Determine objective response rate based on RECIST v1.1 | before breast cancer surgery | |
Secondary | Breast -conserving rate | Breast -conserving rate | up to 24 weeks | |
Secondary | Number of adverse events and serious adverse events | Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 4.0 | After each cycle of chemotherapy (21 days as 1 cycle) |
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