- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04664972
Comparison of TP and TAC Regimens in Neoadjuvant Treatment of TNBC
April 12, 2024 updated by: Zhenzhen Liu, Henan Cancer Hospital
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
212
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Henan
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Zhengzhou, Henan, China, 450008
- Henan Cancer Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pathological complete remission rate (pCR rate)
Time Frame: Immediately after surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event free survival rate (EFS)
Time Frame: 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.
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5 years after surgery
|
Objective response rate
Time Frame: before breast cancer surgery
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Determine objective response rate based on RECIST v1.1
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before breast cancer surgery
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Breast -conserving rate
Time Frame: up to 24 weeks
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Breast -conserving rate
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up to 24 weeks
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Number of adverse events and serious adverse events
Time Frame: After each cycle of chemotherapy (21 days as 1 cycle)
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Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 4.0
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After each cycle of chemotherapy (21 days as 1 cycle)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Zhenzhen Liu, Henan Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 23, 2018
Primary Completion (Actual)
November 26, 2022
Study Completion (Actual)
November 26, 2022
Study Registration Dates
First Submitted
November 9, 2020
First Submitted That Met QC Criteria
December 6, 2020
First Posted (Actual)
December 11, 2020
Study Record Updates
Last Update Posted (Estimated)
April 15, 2024
Last Update Submitted That Met QC Criteria
April 12, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Triple Negative Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Docetaxel
- Cyclophosphamide
- Doxorubicin
Other Study ID Numbers
- HELEN-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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