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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182568
• Other study ID #: KY20192081-F-1
• Status: Recruiting
• Phase: Phase 4
• Start date: August 21, 2019
• Est. completion date: August 21, 2022

Study information

• Verified date: November 2019
• Source: Xijing Hospital
• Contact: Juliang Zhang, Prof
• Phone: 029-84775271
• Email: vascularzhang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 21, 2022
• Est. primary completion date: August 21, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1) age: 18-70 years old, female;

2) patients with primary breast cancer, T2 or above, diagnosed by histopathology;

3) HR was positive and HER-2 was negative by IHC;

4) according to the RECIST 1.1 standard, there should be at least one measurable objective focus with tumor diameter > 2cm;

5) ECoG physical fitness score 0-1;

6) LVEF=55%;

7) bone marrow function: neutrophil = 1.5 × 109 / L, platelet = 100 × 109 / L, hemoglobin = 90g / L;

8) 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;

9) patients have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent

Exclusion Criteria:

• 1) previously received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;

2) patients with stage IV metastasis at the initial diagnosis;

2) New York Heart Association (NYHA) rating of patients with heart disease above grade II (including grade II);

3) patients with serious systemic infection or other serious diseases;

4) patients who are known to be allergic or intolerant to chemotherapy drugs or their adjuvants;

5) in the past 5 years, there have been other malignant tumors, except the cured carcinoma in situ of cervix and skin cancer without melanoma;

6) pregnancy or lactation, as well as childbearing age patients who refuse to take appropriate contraceptive measures during the trial;

7) participated in other experimental studies within 30 days before the administration of the first study drug;

8) patients not suitable for the study were judged by the researchers.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• nab-paclitaxel followed by anthracycline and cyclophosphamide
nab-paclitaxel 260mg/m2 for every 2 weeks followed by anthracycline and cyclophosphamide
• Docetaxel followed by anthracycline and cyclophosphamide
Docetaxel 100 mg/m2 for for every 2 weeks followed by anthracycline and cyclophosphamide

Locations

Country	Name	City	State
China	Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	DFS	Disease free survival	2 years
Other	OS	Overall survival time	2 years
Primary	RCB	Residual tumor load	2 years
Secondary	pCR	Complete remission of Pathology	2 years