Nab-paclitaxel Dose Schedual for HER-2 Negative Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Single-arm Opened Randomized Phase II Study of Nab-paclitaxel Dose Schedual in Advanced Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04192331
• Other study ID #: CABC012
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 21, 2019
• Est. completion date: January 26, 2023

Study information

• Verified date: October 2022
• Source: Peking University Cancer Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

What is the best dosage of Nab-Paclitaxel for chinese? This study would divide patients into two dosage groups: 1) 125mg/m2, 30 minutes intravenous injection, d1, 8, 21 days for a cycle(clinical use); 2) 125mg/m2 d1, 8, 15, 30 minutes intravenous injection, 28 days for a cycle(guideline recommand). Treatment to disease progression. The efficacy (CR, PR, SD, PD) is evaluated every 2-4 cycles.If the patient withdraws from the trial because he cannot tolerate the toxicity caused by one of the drugs, such as neurotoxicity or bone marrow toxicity, it is recommended to switch to other drugs and follow up to PFS and OS.Each group was planned to include 30 patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 97
• Est. completion date: January 26, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Female, aged= 18 years old;

• Histopathologically confirmed HER-2 negative (definition: immunohistochemical IHC 0, or 1+, or in situ hybridization ISH, defined as the ratio of HER2 gene copy number to CEP17 signal number less than 2.0, or for single probe detection, HER2 gene copy number less than 6) in patients with recurrent or metastatic breast cancer;

• Up to two previous lines of chemotherapy were permitted for recurrent and metastatic diseases. And for endocrine therapy, the number of treatment lines can be omitted;

• With measurable lesions;

• The physical condition score of the Eastern American Cancer Collaboration Group (ECOG) was less than 1;

• Expected survival period>3 months;

Exclusion Criteria

• New York Heart Association NYHA scores identify patients with congestive heart failure at grade II or above;Uncontrolled brain metastasis;

• Patients with severe systemic infection;Patients with peripheral nerve injury of degree II or above, or known drug allergy or intolerance within 4 weeks before admission;

• Important organ disorders or diseases: liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis,etc;There is a history of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);

• Patients who had received other antineoplastic treatments or other experimental drugs within one month before treatment;

• Patients who also participated in other clinical trials;

• Researchers believe that patients are not suitable for any medical condition to enter the study.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• nab-paclitaxel regimen1
nab-paclitaxel regimen1 means use abraxine with 125mg/m2 at day 1 and day 8 per 21d.
• nab-paclitaxel regimen2
nab-paclitaxel regimen2 means use abraxine with 125mg/m2 at day 1 and day 8 and day 15 per 28d.

Locations

Country	Name	City	State
China	BeijingCancerH	Haidian	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS of two regimen	progession free survival and objective remission rate was put in to assessment after 2-4 cycle of treatment of either two regimen	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Side effect of two regimen	toxicity and tolerability would be evaluated after every cycle of treatment and will report a SAE within 24h	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months