Triple Negative Breast Cancer
Conditions
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 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.
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 neoadjuvant chemotherapy (docetaxel 75 mg / m2 day 1 + cisplatin 25 mg / m2 day 1, 2, 3), 21 days as a cycle. The control group was treated with TAC (docetaxel 75mg / M2 + adriamycin 50mg / M2 + cyclophosphamide 500mg / m2) for 6 cycles, 21 days as a cycle. To compare the efficacy and safety of 6\*TP (docetaxel + cisplatin) regimen and traditional 6\*TAC (docetaxel + doxorubicin + cyclophosphamide) regimen in neoadjuvant chemotherapy of TNBC.
Interventions
DRUGDocetaxel +doxorubicin+ cyclophosphamide
The control group was treated with TAC (docetaxel 75 mg / m2 + adriamycin 50 mg / m2 + cyclophosphamide 500 mg / m2) for 6 cycles, 21 days was a cycle.
DRUGDocetaxel +Cisplatin
The experimental group was treated with TP (docetaxel 75mg/m2 day 1 + cisplatin 25 mg/m2 day 1,2,3) neoadjuvant chemotherapy for 6 cycles, 21 days as a cycle.
Sponsors
Henan Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-70. 2. Clinical stage Ⅱ-Ⅲ. 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 without FISH amplification). 4. With clinically measurable focus: Measurable lesions observed on ultrasound, mammography, or magnetic resonance imaging (optional) within the month prior to randomization. 5. 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; 6. Cardiac ultrasound EF value ≥ 55%. 7. Females of childbearing age with negative serum pregnancy test 14 days before randomization. 8. ECOG score ≤1. 9. Sign informed consent.
Exclusion criteria
1. 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) . 2. The patients have received chemotherapy, endocrine therapy, targeted therapy, and radiation therapy for this disease. 3. The patient has a second primary malignant tumor, except for: \- Thoroughly treated skin cancer 4. Due to severe and uncontrollable other medical diseases, researchers believe the existence of chemotherapy contraindications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The pathological complete remission rate (pCR rate) | Immediately after surgery | Pathological complete response rate (PCR rate), which means there is no invasive cancer (i.e. ypT0/is, ypN0) in the excised specimen (breast+lymphnode) following neoadjuvant chemotherapy and surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event free survival rate (EFS) | 5 years after surgery | 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. |
| Clinical response rate (CRR) | before breast cancer surgery | CRR judged based on RECIST v1.1 |
| Breast -conserving rate | up to 24 weeks | Breast -conserving rate |
| Number of adverse events and serious adverse events | After each cycle of chemotherapy (21 days as 1 cycle) | Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 4.0 |
Countries
China
Outcome results
None listed