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AK105 Plus Anlotinib Hydrochloride Combined With Albumin Paclitaxel as a First-line Therapy in Patients With Advanced Triple-negative Breast Cancer

NCT05244993 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-07-12

No results posted yet for this study

Summary

This trial used a multicentre, single-arm design in which patients were treated with AK105 plus Anlotinib Hydrochloride combined with albumin paclitaxel. Patients included in this trial were advanced breast cancer with hormone receptor negative and Her2 negative. The primary endpoint is ORR, and the secondary endpoint is DCR, PFS, OS and safety.

Conditions

  • Breast Neoplasm Female

Interventions

DRUG

AK105

AK105: 100mg per bottle, 200mg IV Day 1, cycled every 21 days

DRUG

Anlotinib hydrochloride

Anlotinib Hydrochloride: 12mg per capsule, 12 mg PO once daily on Days 1-14, cycled every 21 days

DRUG

Albumin Paclitaxel

Albumin paclitaxel: 100mg per bottle, 125mg/m2 IV Days 1, 8, cycled every 21 days

Sponsors & Collaborators

  • Huludao central hospital

    collaborator UNKNOWN

  • Anshan Tumor Hospital

    collaborator OTHER

  • Chaoyang Central Hospital

    collaborator OTHER

  • Fukuang General Hospital of Liaoning health industry group

    collaborator UNKNOWN

  • Liaoning Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Tao Sun, Doctor · Liaoning Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2024-03-31
Completion
2024-03-31

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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 NCT05244993 on ClinicalTrials.gov