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

Breast Cancer Clinical Trial

Official title:

Nab-Paclitaxel in Patients With ER+/HER2- Recurrent Metastatic Breast Cancer：a Multi-center Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04194684
• Other study ID #: NCC2129
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 28, 2019
• Est. completion date: January 30, 2023

Study information

• Verified date: December 2019
• Source: Chinese Academy of Medical Sciences
• Contact: Peng Yuan
• Phone: +8613501270834
• Email: yuanpeng01[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: January 30, 2023
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Female, 18 to 70 years old;

2. 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);

3. After transfer, =2 lines and =1 line endocrine therapy, and progress;

4. at least one measurable lesion according to RECIST 1.1 ;

5. ECOG score=2;

6. Expected survival=3 months;

7. Bone marrow function: white blood cells=3×109/L, neutrophils=1.5×109/L, platelets =100×109 / L, hemoglobin=90g / L;

8. 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;

9. taxane adjuvant chemotherapy for more than 1 year;

10. 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

11. Sign written informed consent before the test.

Exclusion Criteria:

1. Received chemotherapy after transfer;

2. Patients with congestive heart failure with a grade II or above identified by the New York Heart Association (NYHA) score;

3. Uncontrolled brain metastases;

4. Severe systemic infections;

5. Peripheral neuropathy of degree II or above within 4 weeks before enrollment, or patients known to be allergic or intolerant to this drug;

6. Important organ diseases:liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis, etc .;

7. History of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma);

8. Received other anti-tumor treatments or other experimental drugs within 1 month before starting treatment;

9. Patients participating in other clinical trials at the same time;

10. Any medical condition in which the investigator considers the patient unsuitable for study

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• nab-paclitaxel
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical benefit rate	Defined as proportion of complete response ?partial response and stable disease according to RECIST 1.1 criteria.	CR+PR+SD=8 weeks
Secondary	Progression-Free Survival (PFS)	Calculated from the time the study drug was first administered to the first confirmation of disease progression or death (whichever occurs first)	Estimated up to 2 year