Nab-paclitaxel Compared With Docetaxel in the Neoadjuvant Chemotherapy Breast Cancer
Primary Purpose
Breast Cancer, Chemotherapy Effect
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nab paclitaxel
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Female patients with age range ≥ 18 years;
- a single invasive breast cancer conforming to the clinical diagnostic criteria and histologically confirmed.
- HER2 negative breast cancer, tumor >2 cm, clinical staging conforms to T2-4 phase (defined by immunohistochemistry as 0-1+ or by immunohistochemistry as 2+, without HER2 amplification by Fluorescence in situ hybridization(FISH), chemiluminescent in situ hybridization(CISH) or other amplification tests).
- Known hormone receptor status (estrogen receptor [ER], progesterone receptor [PR]), known Ki67 value;
- Eastern Cooperative Oncology Group(ECOG) performance status is 0 or 1;
- patients have not previously had breast cancer treatment.
- During the study, be able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
- Subjects have the ability to understand, agree and sign the study informed consent form (ICF) before initiating any protocol related procedures; The subject has the ability to express consent (when applicable);
- Normal blood, kidney and liver functions (ANC ≥ 1500 / mm3, platelet(PLT)≥ 100000 / mm3, serum creatinine and total bilirubin ≤ 1.5 times of the upper limit of normal, glutamic oxalacetic transaminase(AST) and glutamic-pyruvic transaminase(ALT) ≤ 3 times of the upper limit of normal).
Exclusion Criteria:
- bilateral invasive breast cancer, metastatic disease or other malignant tumors.
- Surgical axillary staging surgery was performed within 6 months before entering the study;
- Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures;
- before the start of the study, radiotherapy, chemotherapy, biological therapy and / or hormone therapy for the current diagnosis of breast cancer were carried out.
- Patients with central nervous system metastasis or > grade 1 peripheral neuropathy;
- Patients with severe myelosuppression at the time of screening;
- Patients with severe liver dysfunction (child's class III) or renal dysfunction at the time of screening;
- Other concomitant diseases that the researchers believe are seriously harmful to the safety of patients or will hinder the implementation or completion of treatment plan (such as untreated congenital heart disease, glomerulonephritis, etc.);
- Allergic to albumin for injection, paclitaxel, epirubicin, cyclophosphamide and docetaxel;
- Patients with mental disorders;
- Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks (or 5 half lives of the study drug) from the end of the previous clinical study (last administration);
- Other situations that may affect the progress of clinical research and the judgment of research results and are not suitable for inclusion in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Arm1: epirubicin + cyclophosphamide followed by docetaxel
Arm2: epirubicin + cyclophosphamide followed by nab-paclitaxel
Arm3: nab-paclitaxel combined with epirubicin + cyclophosphamide
Arm Description
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Docetaxel :75 mg/m2, D1, q3W, 4 cycles
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Nab-paclitaxel :260 mg/m2, d1, q3W; 4 cycles
Nab-paclitaxel :260 mg/m2, D1, q3W; Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 6 cycles
Outcomes
Primary Outcome Measures
pathologic complete response (pCR) rate
Proportion of PCR patients in enrolled breast cancer patients
Secondary Outcome Measures
Total clinical response rate
The clinical response rate was assessed by ultrasound measurement of tumor size
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05251766
Brief Title
Nab-paclitaxel Compared With Docetaxel in the Neoadjuvant Chemotherapy Breast Cancer
Official Title
Nab-paclitaxel Compared With Docetaxel Combined With Epirubicin and Cyclophosphamide in the Neoadjuvant Chemotherapy Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 20, 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xuli Meng
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
Comparison of docetaxel and Nab-paclitaxel in neoadjuvant chemotherapy for breast cancer
Detailed Description
1. To analyze and compare the efficacy and safety of epirubicin + cyclophosphamide (EC) followed by docetaxel and EC followed by nab-paclitaxel in neoadjuvant chemotherapy of breast cancer; 2. To analyze and compare the efficacy and safety of nab-paclitaxel combined with epirubicin + cyclophosphamide (EC) chemotherapy regimen in neoadjuvant therapy of breast cancer, so as to provide a new treatment option for patients with human epidermal growth factor receptor 2(HER2)-negative breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Chemotherapy Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm1: epirubicin + cyclophosphamide followed by docetaxel
Arm Type
Active Comparator
Arm Description
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Docetaxel :75 mg/m2, D1, q3W, 4 cycles
Arm Title
Arm2: epirubicin + cyclophosphamide followed by nab-paclitaxel
Arm Type
Experimental
Arm Description
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Nab-paclitaxel :260 mg/m2, d1, q3W; 4 cycles
Arm Title
Arm3: nab-paclitaxel combined with epirubicin + cyclophosphamide
Arm Type
Experimental
Arm Description
Nab-paclitaxel :260 mg/m2, D1, q3W; Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 6 cycles
Intervention Type
Drug
Intervention Name(s)
Nab paclitaxel
Other Intervention Name(s)
Aiyue(Jiangsu Hengrui Pharmaceuticals Co.)
Intervention Description
To analyze and compare the efficacy and safety of epirubicin + cyclophosphamide (EC) followed by docetaxel and EC followed by nab-paclitaxel in neoadjuvant chemotherapy of breast cancer; To analyze and compare the efficacy and safety of nab-paclitaxel combined with epirubicin + cyclophosphamide (EC) chemotherapy regimen in neoadjuvant therapy of breast cancer, so as to provide a new treatment option for patients with HER2-negative breast cancer.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Tianlun(Yangzijiang Pharmaceuticals Co.)
Intervention Description
To analyze and compare the efficacy and safety of epirubicin + cyclophosphamide (EC) followed by docetaxel and EC followed by nab-paclitaxel in neoadjuvant chemotherapy of breast cancer; To analyze and compare the efficacy and safety of nab-paclitaxel combined with epirubicin + cyclophosphamide (EC) chemotherapy regimen in neoadjuvant therapy of breast cancer, so as to provide a new treatment option for patients with HER2-negative breast cancer.
Primary Outcome Measure Information:
Title
pathologic complete response (pCR) rate
Description
Proportion of PCR patients in enrolled breast cancer patients
Time Frame
21 weeks
Secondary Outcome Measure Information:
Title
Total clinical response rate
Description
The clinical response rate was assessed by ultrasound measurement of tumor size
Time Frame
21 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients with age range ≥ 18 years;
a single invasive breast cancer conforming to the clinical diagnostic criteria and histologically confirmed.
HER2 negative breast cancer, tumor >2 cm, clinical staging conforms to T2-4 phase (defined by immunohistochemistry as 0-1+ or by immunohistochemistry as 2+, without HER2 amplification by Fluorescence in situ hybridization(FISH), chemiluminescent in situ hybridization(CISH) or other amplification tests).
Known hormone receptor status (estrogen receptor [ER], progesterone receptor [PR]), known Ki67 value;
Eastern Cooperative Oncology Group(ECOG) performance status is 0 or 1;
patients have not previously had breast cancer treatment.
During the study, be able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
Subjects have the ability to understand, agree and sign the study informed consent form (ICF) before initiating any protocol related procedures; The subject has the ability to express consent (when applicable);
Normal blood, kidney and liver functions (ANC ≥ 1500 / mm3, platelet(PLT)≥ 100000 / mm3, serum creatinine and total bilirubin ≤ 1.5 times of the upper limit of normal, glutamic oxalacetic transaminase(AST) and glutamic-pyruvic transaminase(ALT) ≤ 3 times of the upper limit of normal).
Exclusion Criteria:
bilateral invasive breast cancer, metastatic disease or other malignant tumors.
Surgical axillary staging surgery was performed within 6 months before entering the study;
Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures;
before the start of the study, radiotherapy, chemotherapy, biological therapy and / or hormone therapy for the current diagnosis of breast cancer were carried out.
Patients with central nervous system metastasis or > grade 1 peripheral neuropathy;
Patients with severe myelosuppression at the time of screening;
Patients with severe liver dysfunction (child's class III) or renal dysfunction at the time of screening;
Other concomitant diseases that the researchers believe are seriously harmful to the safety of patients or will hinder the implementation or completion of treatment plan (such as untreated congenital heart disease, glomerulonephritis, etc.);
Allergic to albumin for injection, paclitaxel, epirubicin, cyclophosphamide and docetaxel;
Patients with mental disorders;
Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks (or 5 half lives of the study drug) from the end of the previous clinical study (last administration);
Other situations that may affect the progress of clinical research and the judgment of research results and are not suitable for inclusion in the study.
12. IPD Sharing Statement
Learn more about this trial
Nab-paclitaxel Compared With Docetaxel in the Neoadjuvant Chemotherapy Breast Cancer
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