Nab-paclitaxel Compared With Docetaxel in the Neoadjuvant Chemotherapy Breast Cancer

Phase 1

• Conditions: Breast Cancer; Chemotherapy Effect
• Interventions: Drug: Docetaxel; Drug: Nab paclitaxel

• Registration Number: NCT05251766
• Lead Sponsor: Xuli Meng

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.

Study Timeline

• Study First Submitted: 2022-01-18
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-02-11
• Study First Posted: 2022-02-23
• Last Update Posted: 2022-02-23
• Study Start: 2022-04-20
• Primary Completion: 2022-12-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Female patients with age range ≥ 18 years;
2. a single invasive breast cancer conforming to the clinical diagnostic criteria and histologically confirmed.
3. 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).
4. Known hormone receptor status (estrogen receptor [ER], progesterone receptor [PR]), known Ki67 value;
5. Eastern Cooperative Oncology Group(ECOG) performance status is 0 or 1;
6. patients have not previously had breast cancer treatment.
7. During the study, be able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
8. 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);
9. 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

1. bilateral invasive breast cancer, metastatic disease or other malignant tumors.
2. Surgical axillary staging surgery was performed within 6 months before entering the study;
3. Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures;
4. before the start of the study, radiotherapy, chemotherapy, biological therapy and / or hormone therapy for the current diagnosis of breast cancer were carried out.
5. Patients with central nervous system metastasis or > grade 1 peripheral neuropathy;
6. Patients with severe myelosuppression at the time of screening;
7. Patients with severe liver dysfunction (child's class III) or renal dysfunction at the time of screening;
8. 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.);
9. Allergic to albumin for injection, paclitaxel, epirubicin, cyclophosphamide and docetaxel;
10. Patients with mental disorders;
11. 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);
12. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm1: epirubicin + cyclophosphamide followed by docetaxel	Docetaxel	Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Docetaxel :75 mg/m2, D1, q3W, 4 cycles
Arm2: epirubicin + cyclophosphamide followed by nab-paclitaxel	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
Arm3: nab-paclitaxel combined with epirubicin + cyclophosphamide	Nab paclitaxel	Nab-paclitaxel :260 mg/m2, D1, q3W; Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 6 cycles

Primary Outcome Measures

Name	Time	Method
pathologic complete response (pCR) rate	21 weeks	Proportion of PCR patients in enrolled breast cancer patients

Secondary Outcome Measures

Name	Time	Method
Total clinical response rate	21 weeks	The clinical response rate was assessed by ultrasound measurement of tumor size