Nab-paclitaxel Compared With Docetaxel Followed by Anthracyclines and Cyclophosphamide in the Neoadjuvant Breast Cancer

NCT04182568 | Unknown Phase 4

• 1 other identifier: KY20192081-F-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open, multicenter, randomized controlled clinical trial for patients with newly diagnosed primary invasive breast cancer and clinical stage of T2 or above. The main purpose of this study is to evaluate the efficacy of dose-dense nab-paclitaxel compared with dose-dense docetaxel followed by anthracycline and cyclophosphamide in the treatment of HR positive and HER-2 negative breast cancer. The effectiveness and safety of the treatment.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• RCB

  Residual tumor load

  2 years

Secondary Outcomes (1)

• pCR

  2 years

Other Outcomes (2)

• DFS

  2 years

• OS

  2 years

Study Arms (2)

nab-paclitaxel

EXPERIMENTAL

Drug: nab-paclitaxel followed by anthracycline and cyclophosphamide

Docetaxel

ACTIVE COMPARATOR

Drug: Docetaxel followed by anthracycline and cyclophosphamide

Interventions

nab-paclitaxel followed by anthracycline and cyclophosphamide DRUG

nab-paclitaxel 260mg/m2 for every 2 weeks followed by anthracycline and cyclophosphamide

nab-paclitaxel

Docetaxel followed by anthracycline and cyclophosphamide DRUG

Docetaxel 100 mg/m2 for for every 2 weeks followed by anthracycline and cyclophosphamide

Docetaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age: 18-70 years old, female;
• \) patients with primary breast cancer, T2 or above, diagnosed by histopathology;
• \) HR was positive and HER-2 was negative by IHC;
• \) according to the RECIST 1.1 standard, there should be at least one measurable objective focus with tumor diameter \> 2cm;
• \) ECoG physical fitness score 0-1;
• \) LVEF≥55%；
• \) bone marrow function: neutrophil ≥ 1.5 × 109 / L, platelet ≥ 100 × 109 / L, hemoglobin ≥ 90g / L;
• \) liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and alt ≤ 2.5 times the upper limit of normal value; total bilirubin ≤ 1.5 times the upper limit of normal value, or patients with Gilbert's syndrome ≤ 2.5 times the upper limit of normal value;
• \) patients have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent

You may not qualify if:

• \) previously received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;
• \) patients with stage IV metastasis at the initial diagnosis;
• \) New York Heart Association (NYHA) rating of patients with heart disease above grade II (including grade II);
• \) patients with serious systemic infection or other serious diseases;
• \) patients who are known to be allergic or intolerant to chemotherapy drugs or their adjuvants;
• \) in the past 5 years, there have been other malignant tumors, except the cured carcinoma in situ of cervix and skin cancer without melanoma;
• \) pregnancy or lactation, as well as childbearing age patients who refuse to take appropriate contraceptive measures during the trial;
• \) participated in other experimental studies within 30 days before the administration of the first study drug;
• \) patients not suitable for the study were judged by the researchers.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Juliang Zhang, Prof

CONTACT

029-84775271; vascularzhang@163.com

Meiling Huang, MD

CONTACT

029-8477527; huangmeiling@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 2, 2019
• Study Start: August 21, 2019
• Primary Completion: August 21, 2021
• Study Completion: August 21, 2022
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

CN (1)