Breast Neoplasm FemalePhase 2NCT05244993
AK105 Plus Anlotinib Hydrochloride Combined With Albumin Paclitaxel as a First-line Therapy in Patients With Advanced Triple-negative Breast Cancer
A Phase 2 study testing AK105, Anlotinib hydrochloride and Albumin Paclitaxel in people with Breast Neoplasm Female, run by Liaoning Cancer Hospital & Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- AK105, Anlotinib hydrochloride and Albumin Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
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- 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.
- Biochemical test:
- Total bilirubin≤1.5×ULN (upper limit of normal).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN.
- 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.
Who cannot join
- 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.
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- 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.
- Suffered from other malignant tumors within 5 years before enrollment.
- Unreduced toxicity .
- Multiple factors that affect oral medications.
- Abnormal coagulation function.
- Major surgical treatment, open biopsy or traumatic injury within 4 weeks.
- Tumor has invaded the periphery of important blood vessels.
- Patients who have seizures.
- Bleeding constitution or medical history.
- Arterial/venous thrombotic events before enrollment or within 6 months.
- Live attenuated vaccine vaccination within 28 days before the study.
- Uncontrollable pleural, abdominal or pericardial effusion.
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- AK105, Anlotinib hydrochloride, Albumin Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK105Drug
Also called Penpulimab
AK105: 100mg per bottle, 200mg IV Day 1, cycled every 21 days
Anlotinib hydrochlorideDrug
Anlotinib Hydrochloride: 12mg per capsule, 12 mg PO once daily on Days 1-14, cycled every 21 days
Albumin PaclitaxelDrug
Albumin paclitaxel: 100mg per bottle, 125mg/m2 IV Days 1, 8, cycled every 21 days
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: AK105; Drug: Anlotinib hydrochloride; Drug: Albumin Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 10 months
Secondary outcomes (3)
Disease Control Rate (DCR)
DCR: Disease Control Rate, defined as the proportion of patients with the best overall response of complete response (CR) , partial response (PR) or stable disease (SD) according to RECIST 1.1.
Measured: Up to approximately 10 months
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause.
Measured: Up to approximately 10 months
Overall Survival (OS)
OS: Time from date of randomization to the date of death from any cause.
Measured: Up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study startJul 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Huludao central hospital, Anshan Tumor Hospital, Chaoyang Central Hospital, Fukuang General Hospital of Liaoning health industry group
- Responsible party
- Principal investigator, Tao Sun, Liaoning Cancer Hospital & Institute
- Investigators
- Tao Sun, Doctor, Principal investigator, Liaoning Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244993
- Sponsor's protocol ID
- ALTER-BC-003
- Status last verified
- Jul 2022
- First submitted
- 8 Feb 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AK105 Plus Anlotinib Hydrochloride Combined With Albumin Paclitaxel as a First-line Therapy in Patients With Advanced Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05244993
- Acronym / sponsor ID
- ALTER-BC-003
- Conditions
- Breast Neoplasm Female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Liaoning Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Huludao central hospital, Anshan Tumor Hospital, Chaoyang Central Hospital, Fukuang General Hospital of Liaoning health industry group
- Study start
- Jul 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK105+Anlotinib Hydrochloride+Albumin Paclitaxel | Experimental | Drug: AK105, Drug: Anlotinib hydrochloride, Drug: Albumin PaclitaxelAK105 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Female aged 18-75 years old.
- ECOG 0 or 1 point.
- Advanced triple-negative invasive 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 .
Key exclusion criteria (30 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK105Also: PenpulimabAK105: 100mg per bottle, 200mg IV Day 1, cycled every 21 days | Drug | AK105+Anlotinib Hydrochloride+Albumin Paclitaxel |
| Anlotinib hydrochlorideAnlotinib Hydrochloride: 12mg per capsule, 12 mg PO once daily on Days 1-14, cycled every 21 days | Drug | AK105+Anlotinib Hydrochloride+Albumin Paclitaxel |
| Albumin PaclitaxelAlbumin paclitaxel: 100mg per bottle, 125mg/m2 IV Days 1, 8, cycled every 21 days | Drug | AK105+Anlotinib Hydrochloride+Albumin Paclitaxel |
Primary outcome
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.
3 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to approximately 10 months
Progression Free Survival (PFS)
Time frame: Up to approximately 10 months
Overall Survival (OS)
Time frame: Up to approximately 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Sun, Doctor principal investigator
Liaoning Cancer Hospital & Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK105, Anlotinib hydrochloride and Albumin Paclitaxel in people with Breast Neoplasm Female, run by Liaoning Cancer Hospital & Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Sun, Doctor (0086-18624005672, lnszl2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Up to approximately 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.