Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer

NCT04194684 | Unknown Phase 2

• 1 other identifier: NCC2129
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-arm, open, multi-center clinical study of nab-paclitaxel as the therapy ER+/HER2- recurrent metastatic breast cancer。

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.

  Estimated up to 1 year

Secondary Outcomes (2)

• Clinical benefit rate

  CR+PR+SD≥8 weeks

• Progression-Free Survival (PFS)

  Estimated up to 2 year

Study Arms (1)

Assigned Interventions

EXPERIMENTAL

Nab-paclitaxel

Drug: nab-paclitaxel

Interventions

nab-paclitaxel DRUG

nab-paclitaxel 125mg / m2, intravenous drip 30min, d1, 8, 21 days as a cycle, until the disease progresses or intolerable toxicity. According to the calculation results, the administered dose can be within ± 10% of the calculated dose.

Assigned Interventions

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, 18 to 70 years old;
• histologically confirmed recurrent or metastatic breast cancer, ER-positive (\> 10%), HER-2 negative (Definition: immunohistochemical \[IHC\] 0, 1+, or in situ hybridization \[ISH\] negative It is defined as the ratio of HER2 gene copy number to the number of CEP17 signals is less than 2.0, or for single probe detection, the HER2 gene copy number is less than 6);
• After transfer, ≤2 lines and ≥1 line endocrine therapy, and progress;
• at least one measurable lesion according to RECIST 1.1 ;
• ECOG score≤2;
• Expected survival≥3 months;
• Bone marrow function: white blood cells≥3×109/L, neutrophils≥1.5×109/L, platelets ≥100×109 / L, hemoglobin≥90g / L;
• Liver and kidney function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤2.5 times the upper limit of normal value; if due to liver metastasis, the above indicators ≤5 times the upper limit of normal value; serum creatinine (Cr) ≤1.5 times the upper limit of normal value;
• taxane adjuvant chemotherapy for more than 1 year;
• Women of childbearing age have a negative pregnancy test and must agree to take effective contraceptive measures during the study and within 3 months after the last dose
• Sign written informed consent before the test.

You may not qualify if:

• Received chemotherapy after transfer;
• Patients with congestive heart failure with a grade II or above identified by the New York Heart Association (NYHA) score;
• Uncontrolled brain metastases;
• Severe systemic infections;
• Peripheral neuropathy of degree II or above within 4 weeks before enrollment, or patients known to be allergic or intolerant to this drug;
• Important organ diseases:liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis, etc .;
• History of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);
• Received other anti-tumor treatments or other experimental drugs within 1 month before starting treatment;
• Patients participating in other clinical trials at the same time;
• Any medical condition in which the investigator considers the patient unsuitable for study

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peng Yuan

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Peng Yuan

CONTACT

+8613501270834; yuanpeng01@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 11, 2019
• Study Start: December 28, 2019
• Primary Completion: December 28, 2022
• Study Completion: January 30, 2023
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share