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SHR-1210 Combined With Albumin-bound Paclitaxel and Epirubicin Neoadjuvant for Triple Negative Breast Cancer

NCT04213898 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2019-12-30

No results posted yet for this study

Summary

Triple negative breast cancer (TNBC), characterized by estrogen receptor, progesterone receptor and HER2 negative, accounts for 10-20% of all breast cancers and usually occurs in young women. It is an aggressive and worst prognosis breast cancer subtype, which urgently requires effective treatment.The pathological complete response (pCR) of neoadjuvant therapy is associated with disease-free survival (DFS) and overall survival (OS) of breast cancer. The correlation between pathological response and long-term survival in patients with early-stage breast cancer is the strongest among patients with triple-negative breast cancer.

Conditions

  • Triple-negative Breast Cancer

Interventions

DRUG

SHR-1210+Albumin-bound paclitaxel + epirubicin

Neoadjuvant therapy：SHR-1210, 200mg,iv, q3w, for 6 cycles; Albumin-bound paclitaxel: 125 mg/m2, iv, d1, d8, and d15, 21 days as a cycle, for 6 cycles; Epirubicin: 75mg / m2, iv, d1, 21 days as a cycle, for 6 cycles; The surgery was performed 3-4 weeks after the completion of neoadjuvant chemotherapy.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-01-31
Completion
2023-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04213898 on ClinicalTrials.gov