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

NCT ID: NCT04192331

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-21
• Study Completion Date: 2023-01-26

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2/3dose strategy

HER2 negative advanced breast cancer patient

Group Type: EXPERIMENTAL

nab-paclitaxel regimen1

Intervention Type: DRUG

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

3/4dose strategy

HER2 negative advanced breast cancer patient

Group Type: ACTIVE_COMPARATOR

nab-paclitaxel regimen2

Intervention Type: DRUG

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

Interventions

nab-paclitaxel regimen1

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

Intervention Type: DRUG

nab-paclitaxel regimen2

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

Intervention Type: DRUG

Other Intervention Names

regimen1; regimen2

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Li Huiping

Head of the department of breast oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

BeijingCancerH

Haidian, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37882706 (View on PubMed)

Other Identifiers

CABC012

Identifier Type: -

Identifier Source: org_study_id