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

• Sponsor: Xuli Meng (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05251766
• Collaborator: (none)
• Enrollment: 30
• Arms: 3
• Anticipated Duration (Months): 14.3

Study Details

Study Description

Brief Summary

Comparison of docetaxel and Nab-paclitaxel in neoadjuvant chemotherapy for breast cancer

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Chemotherapy Effect	Drug: Nab paclitaxel; Drug: Docetaxel	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Nab-paclitaxel Compared With Docetaxel Combined With Epirubicin and Cyclophosphamide in the Neoadjuvant Chemotherapy Breast Cancer
• Anticipated Study Start Date: Apr 20, 2022
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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.)

Outcome Measures

Primary Outcome Measures

1. pathologic complete response (pCR) rate [21 weeks]

   Proportion of PCR patients in enrolled breast cancer patients

Secondary Outcome Measures

1. Total clinical response rate [21 weeks]

   The clinical response rate was assessed by ultrasound measurement of tumor size

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Xuli Meng

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xuli Meng, chief physician, Zhejiang Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT05251766
• Other Study ID Numbers: SRMBCNabP2022
• First Posted: Feb 23, 2022
• Last Update Posted: Feb 23, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Paclitaxel; Docetaxel

Study Results

No Results Posted as of Feb 23, 2022