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

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: Breast Cancer; Chemotherapy Effect
• Intervention / Treatment: Drug: Docetaxel; Drug: Nab paclitaxel

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

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:

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

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	Drug: Docetaxel; 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: Tianlun(Yangzijiang Pharmaceuticals Co.)
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	Drug: Nab paclitaxel; 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: Aiyue(Jiangsu Hengrui Pharmaceuticals Co.)
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	Drug: Nab paclitaxel; 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: Aiyue(Jiangsu Hengrui Pharmaceuticals Co.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathologic complete response (pCR) rate	Proportion of PCR patients in enrolled breast cancer patients	21 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total clinical response rate	The clinical response rate was assessed by ultrasound measurement of tumor size	21 weeks

Collaborators and Investigators

• Sponsor: Xuli Meng

Study record dates

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: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Docetaxel; Paclitaxel
• 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