Back to resultsThe TP Regimen in the Treatment of Early Triple Negative Breast Cancer
Primary Purpose
Triple Negative Breast Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel +doxorubicin+ cyclophosphamide
Docetaxel +Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Age: 18-70.
- Clinical T2-T4c, or T1c with axillary LN+.
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).
- 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.
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.
- The EF value of echocardiography≥55%.
- The serum pregnancy test was negative for fertile woman within 14 days before randomization..
- KPS score≥80.
- Informed consent.
Exclusion Criteria:
- Metastatic breast cancer.
- Before entering the clinical trial, patients had received chemotherapy, endocrine therapy, targeted therapy, radiotherapy and so on.
- The patient had dual primary malignancies, except for skin cancer, which was treated.
- Combined with other serious and uncontrollable medical diseases, the researchers judged that the disease had chemotherapy contraindications.
Sites / Locations
- Henan Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
TAC regimen group
TP regimen group
Arm Description
The control group was treated with TAC (docetaxel 75mg/m2 + adriamycin 50mg /m2 + cyclophosphamide 500mg/m2) for 6 cycles, 21 days as a cycle.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Clinical response rate
Clinical response rate is judged by RECIST v1.1
Difference of PCR rate between BRCA mutation and wild type
Mutation of BRCA gene in triple negative breast cancer
Differences in PCR ratio of BRCA mutations and BRCA wild-type patients
Differences in PCR ratio of BRCA mutations and BRCA wild-type patients
Clinical reaction rate
Clinical reaction rate determines according to Recist V1.1
Breast -conserving rate
Breast -conserving rate
Disease-free survival
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
Safety According to CTCAE 4.0 evaluates the nature, incidence and severity of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04664972
Brief Title
The TP Regimen in the Treatment of Early Triple Negative Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 23, 2018 (Actual)
Primary Completion Date
November 26, 2022 (Actual)
Study Completion Date
November 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAC regimen group
Arm Type
Placebo Comparator
Arm Description
The control group was treated with TAC (docetaxel 75mg/m2 + adriamycin 50mg /m2 + cyclophosphamide 500mg/m2) for 6 cycles, 21 days as a cycle.
Arm Title
TP regimen group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel +doxorubicin+ cyclophosphamide
Other Intervention Name(s)
TAC regimen group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel +Cisplatin
Other Intervention Name(s)
TP regimen group
Intervention Description
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.
Primary Outcome Measure Information:
Title
The pathological complete remission rate (pCR rate)
Description
It means that there is no invasive cancer (i.e. ypT0/is, ypN0) in the resected specimens (breast + armpit) after operation
Time Frame
After neoadjuvant chemotherapy+surgery
Secondary Outcome Measure Information:
Title
Clinical response rate
Description
Clinical response rate is judged by RECIST v1.1
Time Frame
Adverse events that occurred throughout the study, an average of 15 weeks
Title
Difference of PCR rate between BRCA mutation and wild type
Description
Mutation of BRCA gene in triple negative breast cancer
Time Frame
After neoadjuvant chemotherapy+surgery, an average of 15 weeks
Title
Differences in PCR ratio of BRCA mutations and BRCA wild-type patients
Description
Differences in PCR ratio of BRCA mutations and BRCA wild-type patients
Time Frame
BRCA detection before neoadjuvant chemotherapy.
Title
Clinical reaction rate
Description
Clinical reaction rate determines according to Recist V1.1
Time Frame
After each cycle of chemotherapy（21 days as a cycle）
Title
Breast -conserving rate
Description
Breast -conserving rate
Time Frame
After breast cancer surgery，an average of 15 weeks
Title
Disease-free survival
Description
DFS definition is from the date of surgery to the first time, region, alignment or distant recurrence, and death caused by any reason.
Time Frame
5 years and 10 years after surgery
Title
Number of patients with adverse events
Description
Safety According to CTCAE 4.0 evaluates the nature, incidence and severity of adverse events
Time Frame
After each cycle of chemotherapy（21 days as a cycle）
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18-70.
Clinical T2-T4c, or T1c with axillary LN+.
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).
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.
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.
The EF value of echocardiography≥55%.
The serum pregnancy test was negative for fertile woman within 14 days before randomization..
KPS score≥80.
Informed consent.
Exclusion Criteria:
Metastatic breast cancer.
Before entering the clinical trial, patients had received chemotherapy, endocrine therapy, targeted therapy, radiotherapy and so on.
The patient had dual primary malignancies, except for skin cancer, which was treated.
Combined with other serious and uncontrollable medical diseases, the researchers judged that the disease had chemotherapy contraindications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenzhen Liu
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
12. IPD Sharing Statement
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The TP Regimen in the Treatment of Early Triple Negative Breast Cancer
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