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

Sponsor

Peking University Cancer Hospital & Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT04192331

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: nab-paclitaxel regimen1 Drug: nab-paclitaxel regimen2

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 21, 2019

Anticipated Primary Completion Date :

Feb 21, 2021

Anticipated Study Completion Date :

Feb 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
2/3dose strategy HER2 negative advanced breast cancer patient	Drug: nab-paclitaxel regimen1 nab-paclitaxel regimen1 means use abraxine with 125mg/m2 at day 1 and day 8 per 21d. Other Names: regimen1
3/4dose strategy HER2 negative advanced breast cancer patient	Drug: nab-paclitaxel regimen2 nab-paclitaxel regimen2 means use abraxine with 125mg/m2 at day 1 and day 8 and day 15 per 28d. Other Names: regimen2

Arm

Intervention/Treatment

2/3dose strategy

HER2 negative advanced breast cancer patient

Drug: nab-paclitaxel regimen1

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

Other Names:

regimen1

3/4dose strategy

HER2 negative advanced breast cancer patient

Drug: nab-paclitaxel regimen2

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

Other Names:

regimen2

Outcome Measures

Primary Outcome Measures

PFS 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]
progession free survival and objective remission rate was put in to assessment after 2-4 cycle of treatment of either two regimen

Secondary Outcome Measures

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]
toxicity and tolerability would be evaluated after every cycle of treatment and will report a SAE within 24h

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion criteria

Female, aged > 18 years old and < 70 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;
No treatment for recurrent and metastatic diseases or up to two chemotherapy regimens has been received in the past;Previous treatment regimens (neoadjuvant, adjuvant or rescue therapy) must include any combination or other sequence of administration of anthracyclines (e.g. doxorubicin, epirubicin) and taxanes (e.g. paclitaxel, docetaxel);
With measurable lesions;
The physical condition score of the Eastern American Cancer Collaboration Group (ECOG) was less than 2;
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.