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

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

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: nab-paclitaxel

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assigned Interventions; Nab-paclitaxel	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Study Chair: Peng Yuan, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): December 28, 2019
• Primary Completion (Anticipated): December 28, 2022
• Study Completion (Anticipated): January 30, 2023

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: NCC2129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No