The TP Regimen in the Treatment of Early Triple Negative Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 6TP (docetaxel + cisplatin) regimen and traditional 6TAC (docetaxel + doxorubicin + cyclophosphamide) regimen in neoadjuvant chemotherapy of TNBC.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: TAC regimen group The control group was treated with TAC (docetaxel 75mg/m2 + adriamycin 50mg /m2 + cyclophosphamide 500mg/m2) for 6 cycles, 21 days as a cycle. |
Drug: Docetaxel +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.
Other Names:
|
| Experimental: TP regimen group 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. |
Drug: Docetaxel +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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The pathological complete remission rate (pCR rate) [After neoadjuvant chemotherapy+surgery]
It means that there is no invasive cancer (i.e. ypT0/is, ypN0) in the resected specimens (breast + armpit) after operation
Secondary Outcome Measures
- Clinical response rate [Adverse events that occurred throughout the study, an average of 15 weeks]
Clinical response rate is judged by RECIST v1.1
- Difference of PCR rate between BRCA mutation and wild type [After neoadjuvant chemotherapy+surgery, an average of 15 weeks]
Mutation of BRCA gene in triple negative breast cancer
- Differences in PCR ratio of BRCA mutations and BRCA wild-type patients [BRCA detection before neoadjuvant chemotherapy.]
Differences in PCR ratio of BRCA mutations and BRCA wild-type patients
- Clinical reaction rate [After each cycle of chemotherapy（21 days as a cycle）]
Clinical reaction rate determines according to Recist V1.1
- Breast -conserving rate [After breast cancer surgery，an average of 15 weeks]
Breast -conserving rate
- Disease-free survival [5 years and 10 years after surgery]
DFS definition is from the date of surgery to the first time, region, alignment or distant recurrence, and death caused by any reason.
- Number of patients with adverse events [After each cycle of chemotherapy（21 days as a cycle）]
Safety According to CTCAE 4.0 evaluates the nature, incidence and severity of adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age: 18-70.
-
Clinical T2-T4c, or T1c with axillary LN+.
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triple negative and invasive breast cancer confirmed by histopathology:
Triple negative breast cancer is defined as:
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negative for ER and PR (IHC nuclear staining < 10%).
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Her-2 negative (IHC 0,1 + without FISH, or IHC 2 + and FISH without amplification).
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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.
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The function examination of organs/bone marrow showed no contraindication within 1 month before chemotherapy.
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The absolute value of neutrophil count ≥2.0 × 109 / L.
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The value of hemoglobin ≥100g/L.
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Platelet count ≥100 × 109/L.
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Total bilirubin < 1.5 ULN (normal value online).
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Creatinine < 1.5 × ULN.
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AST/ALT < 1.5 × ULN.
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The EF value of echocardiography≥55%.
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The serum pregnancy test was negative for fertile woman within 14 days before randomization..
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KPS score≥80.
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Informed consent.
Exclusion Criteria:
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Metastatic breast cancer.
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Before entering the clinical trial, patients had received chemotherapy, endocrine therapy, targeted therapy, radiotherapy and so on.
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The patient had dual primary malignancies, except for skin cancer, which was treated.
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Combined with other serious and uncontrollable medical diseases, the researchers judged that the disease had chemotherapy contraindications.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Henan Cancer Hospital | Zhengzhou | Henan | China | 450008 |
Sponsors and Collaborators
- Henan Cancer Hospital
Investigators
- Study Director: Zhenzhen Liu, Henan Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HNCH-BC001