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

NCT05244993 | Unknown Phase 2

• 1 other identifier: ALTER-BC-003
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.

  Up to approximately 10 months

Secondary Outcomes (3)

• Disease Control Rate (DCR)

  Up to approximately 10 months

• Progression Free Survival (PFS)

  Up to approximately 10 months

• Overall Survival (OS)

  Up to approximately 18 months

Study Arms (1)

AK105+Anlotinib Hydrochloride+Albumin Paclitaxel

EXPERIMENTAL

AK105 200mg IV Day 1 Anlotinib Hydrochloride 12mg PO once daily on Days 1-14 Albumin paclitaxel 125mg/m2 IV Days 1, 8 Cycled every 21 days until disease progression, death or toxicity is intolerable (for subjects who can continue to tolerate the treatment, albumin paclitaxel lasts for at least 6 cycles)

Drug: AK105; Drug: Anlotinib hydrochloride; Drug: Albumin Paclitaxel

Interventions

AK105 DRUG

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

Also known as: Penpulimab

AK105+Anlotinib Hydrochloride+Albumin Paclitaxel

Anlotinib hydrochloride DRUG

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

AK105+Anlotinib Hydrochloride+Albumin Paclitaxel

Albumin Paclitaxel DRUG

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

AK105+Anlotinib Hydrochloride+Albumin Paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged 18-75 years old.
• ECOG 0 or 1 point.
• Advanced triple-negative invasive breast cancer :
• The pathological classification is triple negative, specifically:
• ER negative: IHC\<1%.
• PR negative: IHC\<1%.
• HER2 negative: IHC-/+ or IHC++ but FISH/CISH is negative.
• 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 .
• The main organs are functioning well, and the blood test results within 14 days before enrollment should meet the following requirements:
• Routine blood test:
• Hemoglobin (HB) ≥90 g/L.
• Neutrophil count (ANC) ≥1.5×109/L.
• Platelet count (PLT) ≥100×109/L.

You may not qualify if:

• 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:
• Patients with any known or suspected autoimmune diseases.
• Hypertension.
• Peripheral neuropathy ≥ Grade 2.
• Persons with a history of unstable angina or arrhythmia.
• Active or uncontrolled serious infection .
• History of immunodeficiency.
• Active hepatitis B or C.
• interstitial lung disease or non-infectious pneumonia.
• Active tuberculosis.
• Urine protein is ≥++, and 24-hour urine protein quantitative is \>1.0g.

Sponsors & Collaborators

• Liaoning Cancer Hospital & Institute: lead
• Huludao central hospital: collaborator
• Anshan Tumor Hospital: collaborator
• Chaoyang Central Hospital: collaborator
• Fukuang General Hospital of Liaoning health industry group: collaborator

MeSH Terms

Interventions

penpulimab

Study Officials

• Tao Sun, Doctor

  Liaoning Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Sun, Doctor

CONTACT

0086-18624005672; lnszl2021@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: July 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 12, 2022

Record last verified: 2022-07