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

NCT ID: NCT05244993

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2024-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK105+Anlotinib Hydrochloride+Albumin Paclitaxel

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)

Group Type: EXPERIMENTAL

AK105

Intervention Type: DRUG

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

Anlotinib hydrochloride

Intervention Type: DRUG

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

Albumin Paclitaxel

Intervention Type: DRUG

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

Interventions

AK105

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

Intervention Type: DRUG

Anlotinib hydrochloride

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

Intervention Type: DRUG

Albumin Paclitaxel

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

Intervention Type: DRUG

Other Intervention Names

Penpulimab

Eligibility Criteria

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 .
• The main organs are functioning well, and the blood test results within 14 days before enrollment should meet the following requirements:

1. Routine blood test:

1. Hemoglobin (HB) ≥90 g/L.

2. Neutrophil count (ANC) ≥1.5×109/L.

3. Platelet count (PLT) ≥100×109/L.

2. Biochemical test:

1. Total bilirubin≤1.5×ULN (upper limit of normal).

2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN.

3. Serum creatinine (Cr) ≤1.5 ULN or creatinine clearance ≥60mL/min.

• Must not be regnant.
• Volunteer to participate in this study and sign an informed consent form.

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 .

6. History of immunodeficiency.

7. Active hepatitis B or C.

8. interstitial lung disease or non-infectious pneumonia.

9. Active tuberculosis.

10. Urine protein is ≥++, and 24-hour urine protein quantitative is >1.0g.

11. Suffered from other malignant tumors within 5 years before enrollment.

12. Unreduced toxicity .

13. Multiple factors that affect oral medications.

14. Abnormal coagulation function.

15. Major surgical treatment, open biopsy or traumatic injury within 4 weeks.

16. Tumor has invaded the periphery of important blood vessels.

17. Patients who have seizures.

18. Bleeding constitution or medical history.

19. Arterial/venous thrombotic events before enrollment or within 6 months.

20. Live attenuated vaccine vaccination within 28 days before the study.

21. Uncontrollable pleural, abdominal or pericardial effusion.

22. Other uncontrollable systemic diseases.

• Other serious physical or mental diseases or laboratory abnormalities.
• Patients who the researcher thinks are not suitable for this research.
• Participated in clinical trials of other anti-tumor drugs within four weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Huludao central hospital

UNKNOWN

Sponsor Role: collaborator

Anshan Tumor Hospital

OTHER

Sponsor Role: collaborator

Chaoyang Central Hospital

OTHER

Sponsor Role: collaborator

Fukuang General Hospital of Liaoning health industry group

UNKNOWN

Sponsor Role: collaborator

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Tao Sun

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tao Sun, Doctor

Role: PRINCIPAL_INVESTIGATOR

Liaoning Cancer Hospital & Institute

Central Contacts

Tao Sun, Doctor

Role: CONTACT

lnszl2021@163.com

0086-18624005672

Other Identifiers

ALTER-BC-003

Identifier Type: -

Identifier Source: org_study_id