- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05251766
Nab-paclitaxel Compared With Docetaxel in the Neoadjuvant Chemotherapy Breast Cancer
February 11, 2022 updated by: Xuli Meng
Nab-paclitaxel Compared With Docetaxel Combined With Epirubicin and Cyclophosphamide in the Neoadjuvant Chemotherapy Breast Cancer
Comparison of docetaxel and Nab-paclitaxel in neoadjuvant chemotherapy for breast cancer
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
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 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
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: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Arm1: epirubicin + cyclophosphamide followed by docetaxel
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Docetaxel :75 mg/m2, D1, q3W, 4 cycles
|
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.
Other Names:
|
EXPERIMENTAL: Arm2: epirubicin + cyclophosphamide followed by nab-paclitaxel
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Nab-paclitaxel :260 mg/m2, d1, q3W; 4 cycles
|
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.
Other Names:
|
EXPERIMENTAL: Arm3: nab-paclitaxel combined with epirubicin + cyclophosphamide
Nab-paclitaxel :260 mg/m2, D1, q3W; Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 6 cycles
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pathologic complete response (pCR) rate
Time Frame: 21 weeks
|
Proportion of PCR patients in enrolled breast cancer patients
|
21 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total clinical response rate
Time Frame: 21 weeks
|
The clinical response rate was assessed by ultrasound measurement of tumor size
|
21 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ANTICIPATED)
April 20, 2022
Primary Completion (ANTICIPATED)
December 30, 2022
Study Completion (ANTICIPATED)
June 30, 2023
Study Registration Dates
First Submitted
January 18, 2022
First Submitted That Met QC Criteria
February 11, 2022
First Posted (ACTUAL)
February 23, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 23, 2022
Last Update Submitted That Met QC Criteria
February 11, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRMBCNabP2022
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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