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

• ClinicalTrials.gov Identifier: NCT04192331
• Recruitment Status: Active, not recruiting
• First Posted: December 10, 2019
• Last Update Posted: October 13, 2022
• Sponsor: Peking University Cancer Hospital & Institute
• Information provided by (Responsible Party): Li Huiping, Peking University Cancer Hospital & Institute

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	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single-arm Opened Randomized Phase II Study of Nab-paclitaxel Dose Schedual in Advanced Breast Cancer
• Actual Study Start Date: February 21, 2019
• Estimated Primary Completion Date: January 26, 2023
• Estimated Study Completion Date: January 26, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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 Name: regimen1
Active Comparator: 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 Name: regimen2

Outcome Measures

Primary Outcome Measures :

1. PFS of two regimen [ Time Frame: 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 :

1. Side effect of two regimen [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China, Beijing

BeijingCancerH

Haidian, Beijing, China, 10010

Sponsors and Collaborators

Peking University Cancer Hospital & Institute

More Information

• Responsible Party: Li Huiping, Head of the department of breast oncology, Peking University Cancer Hospital & Institute
• ClinicalTrials.gov Identifier: NCT04192331
• Other Study ID Numbers: CABC012
• First Posted: December 10, 2019
• Last Update Posted: October 13, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Li Huiping, Peking University Cancer Hospital & Institute:

nab-paclitaxel; advanced breast cancer; HER2 negative; dose

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Paclitaxel; Albumin-Bound Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action