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

NCT05251766 | Unknown Phase 1

• 1 other identifier: SRMBCNabP2022
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• pathologic complete response (pCR) rate

  Proportion of PCR patients in enrolled breast cancer patients

  21 weeks

Secondary Outcomes (1)

• Total clinical response rate

  21 weeks

Study Arms (3)

Arm1: epirubicin + cyclophosphamide followed by docetaxel

ACTIVE COMPARATOR

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

Arm2: epirubicin + cyclophosphamide followed by nab-paclitaxel

EXPERIMENTAL

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

Arm3: nab-paclitaxel combined with epirubicin + cyclophosphamide

EXPERIMENTAL

Nab-paclitaxel :260 mg/m2, D1, q3W; Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 6 cycles

Drug: Nab paclitaxel

Interventions

Nab paclitaxel DRUG

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.

Also known as: Aiyue(Jiangsu Hengrui Pharmaceuticals Co.)

Arm2: epirubicin + cyclophosphamide followed by nab-paclitaxel; Arm3: nab-paclitaxel combined with epirubicin + cyclophosphamide

Docetaxel DRUG

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.

Also known as: Tianlun(Yangzijiang Pharmaceuticals Co.)

Arm1: epirubicin + cyclophosphamide followed by docetaxel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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);

Sponsors & Collaborators

• Xuli Meng: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Taxes; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 23, 2022
• Study Start: April 20, 2022
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: February 23, 2022

Record last verified: 2022-02