AK105 Plus Anlotinib Hydrochloride Combined With Albumin Paclitaxel as a First-line Therapy in Patients With Advanced Triple-negative Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- AK105
- Conditions
- Breast Neoplasm Female
- Sponsor
- Liaoning Tumor Hospital & Institute
- Enrollment
- 42
- Primary Endpoint
- Overall Response Rate (ORR)
- Last Updated
- 3 years ago
Overview
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.
Investigators
Tao Sun
Director
Liaoning Tumor Hospital & Institute
Eligibility Criteria
Inclusion Criteria
- •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 .
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:
- •Patients with any known or suspected autoimmune diseases.
- •Hypertension.
- •Peripheral neuropathy ≥ Grade
- •Persons with a history of unstable angina or arrhythmia.
- •Active or uncontrolled serious infection .
Arms & Interventions
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)
Intervention: AK105
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)
Intervention: Anlotinib hydrochloride
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)
Intervention: Albumin Paclitaxel
Outcomes
Primary Outcomes
Overall Response Rate (ORR)
Time Frame: Up to approximately 10 months
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.
Secondary Outcomes
- Overall Survival (OS)(Up to approximately 18 months)
- Disease Control Rate (DCR)(Up to approximately 10 months)
- Progression Free Survival (PFS)(Up to approximately 10 months)