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

NCT ID: NCT04194684

Last Updated: 2019-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-28
• Study Completion Date: 2023-01-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Assigned Interventions

Nab-paclitaxel

Group Type: EXPERIMENTAL

nab-paclitaxel

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Peng Yuan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peng Yuan

Role: STUDY_CHAIR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Central Contacts

Peng Yuan

Role: CONTACT

Phone: +8613501270834

Email: yuanpeng01@hotmail.com

Other Identifiers

NCC2129

Identifier Type: -

Identifier Source: org_study_id