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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 | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT05244993•Liaoning Cancer Hospital & Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female aged 18-75 years old.
•ECOG 0 or 1 point.
•Advanced triple-negative invasive breast cancer :
•1. The pathological classification is triple negative, specifically:
•1. ER negative: IHC\<1%.
•2. PR negative: IHC\<1%.
•3. HER2 negative: IHC-/+ or IHC++ but FISH/CISH is negative.
•2. Tumor staging: locally advanced or recurrent/metastatic breast cancer.
•If the last chemotherapy drug in the previous adjuvant/neoadjuvant treatment stage is paclitaxel, paclitaxel liposome, paclitaxel albumin or docetaxel, it will take ≥6 months from the end of treatment to enrollment.
•At least one objectively measurable lesion according to the RECIST 1.1 .
+11 more criteria

Exclusion Criteria

•Pregnant, lactating or planning to become pregnant during the study period.
•Allergic to any of the drugs in the study.
•Previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or anti-vascular targeted therapy.
•Central nervous system (CNS) metastases.
•Concomitant disease/medical history:
•1. Patients with any known or suspected autoimmune diseases.
•2. Hypertension.
•3. Peripheral neuropathy ≥ Grade 2.
•4. Persons with a history of unstable angina or arrhythmia.
•5. Active or uncontrolled serious infection .
+20 more criteria

Key Dates

Start Date

July 1, 2022

Primary Completion Date

March 1, 2024

Completion Date

March 1, 2024

Last Updated

July 12, 2022

Enrollment

ESTIMATED participants

Conditions

Breast Neoplasm Female

Interventions

AK105

DRUG

Anlotinib hydrochloride

DRUG

Albumin Paclitaxel

DRUG

Contacts

Tao Sun, Doctor

CONTACT

0086-18624005672 lnszl2021@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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