NCT04192331

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
97

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

3.9 years

First QC Date

April 14, 2019

Last Update Submit

October 11, 2022

Conditions

Breast Cancer

Keywords

nab-paclitaxeladvanced breast cancerHER2 negativedose

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Side effect of 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

Study Arms (2)

2/3dose strategy

EXPERIMENTAL

HER2 negative advanced breast cancer patient

Drug: nab-paclitaxel regimen1

3/4dose strategy

ACTIVE COMPARATOR

HER2 negative advanced breast cancer patient

Drug: nab-paclitaxel regimen2

Interventions

nab-paclitaxel regimen1DRUG

nab-paclitaxel regimen1 means use abraxine with 125mg/m2 at day 1 and day 8 per 21d.

Also known as: regimen1
2/3dose strategy
nab-paclitaxel regimen2DRUG

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

Also known as: regimen2
3/4dose strategy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BeijingCancerH

Haidian, Beijing Municipality, 10010, China

Location

Related Publications (1)

  • Liu Y, Song G, Di L, Jiang H, Ran R, Zhang R, Zhang Y, Li H. Three-Week Versus 4-Week Schedule of nab-Paclitaxel in Patients With Metastatic Breast Cancer: A Randomized Phase II Study. Oncologist. 2023 Dec 11;28(12):1102-e1302. doi: 10.1093/oncolo/oyad288.

    PMID: 37882706DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the department of breast oncology

Study Record Dates

First Submitted

April 14, 2019

First Posted

December 10, 2019

Study Start

February 21, 2019

Primary Completion

January 26, 2023

Study Completion

January 26, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10

Locations

CN(1)