Breast CancerPhase 2NCT06229067
Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With Metronomic VEX in Advanced Triple-negative Breast Cancer
A Phase 2 study testing Adebrelimab, Vinorelbine and Cyclophosphamide (tablet) in people with Breast Cancer and Triple Negative Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
In recent years, immune therapy has significantly altered the treatment landscape for various malignant tumors, including breast cancer. Apart from its direct cytotoxic effects on tumor cells, metronomic chemotherapy has the potential to modulate the immune microenvironment, thereby demonstrating substantial… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- Adebrelimab, Vinorelbine and Cyclophosphamide (tablet)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 19 Jan 2024to 19 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged ≥18 years who have signed informed consent and have an expected survival of ≥3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2 within 21 days prior to the first dose of medication.
- Participants with clear clinical records of metastatic triple-negative breast cancer, as specified in the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.
- Participants with metastatic breast cancer who have received no more than first-line chemotherapy.
- Participants with at least one measurable lesion, as defined by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Participants with a history of receiving anthracycline and/or taxane-based treatments, including:
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- Use of anthracyclines and/or taxanes during adjuvant or neoadjuvant therapy before breast cancer recurrence.
- Ineffectiveness observed during or after chemotherapy based on anthracyclines and/or taxanes.
- Participants deemed unsuitable for first-line treatment with anthracycline and/or taxane-based chemotherapy according to the investigator's judgment.
- Completion of radiotherapy before the first dose of study medication, with a minimum interval of 4 weeks since the end of radiotherapy.
- For participants with a history of surgery, a minimum interval of 30 days between surgery and the first dose of medication, with complete recovery from the surgical procedure.
- Normal bone marrow function, evidenced by:
- Absolute neutrophil count (ANC) ≥ 1500/mm².
- Platelets ≥ 100,000/mm².
- Hemoglobin (Hb) ≥ 10 g/dL.
- Normal liver function, evidenced by:
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN).
- Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 ULN (≤ 5.0 times ULN in the presence of liver metastasis).
- Alkaline phosphatase < 5 x ULN.
- Normal renal function, evidenced by a creatinine clearance rate > 40 mL/min (Cockcroft-Gault formula).
- Negative pregnancy test results within 7 days prior to the first dose of medication for women of childbearing potential, who also agree to employ necessary contraceptive measures.
- Ability to understand and voluntarily sign the informed consent form before any study-related assessments/procedures.
- Willingness and ability to comply with the study visit schedule and other protocol requirements.
Who cannot join
- Current or past history of malignancies other than breast cancer, excluding: cured non-melanoma skin cancer, cured cervical carcinoma in situ, or cured other primary solid tumors with no evidence of disease activity and no curative treatment within the last 3 years.
- Solely having pleural effusion, ascites, bone metastases, or other unmeasurable lesions.
- Malabsorption syndrome or diseases significantly affecting gastrointestinal function, prior gastrectomy, or resection of the proximal small intestine that may affect the absorption of oral chemotherapeutic agents.
- Swallowing difficulties or inability to swallow tablets.
- Symptomatic brain or leptomeningeal metastasis; suspected signs or symptoms of central nervous system (CNS) involvement should be excluded by CT or MRI scans.
- Other severe diseases or medical conditions discovered by the investigator during screening, including:
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- Clinically significant heart diseases.
- Unstable diabetes.
- Uncontrolled hypercalcemia.
- Clinically significant active infections within the last 2 weeks.
- History of organ transplantation.
- Peripheral neuropathy of grade ≥2 according to NCI version 5.0.
- Concurrent use of any other antitumor therapy for metastatic breast cancer.
- Requirement for concurrent anticoagulant therapy.
- Status of pregnancy, lactation, or unwillingness to use effective contraception for at least one month during the entire study period and for at least one month after the last dose of the study drug.
- Known history of neurologic or psychiatric disorders or diseases that could compromise treatment compliance.
- Less than a 3-week interval between the end of previous chemotherapy and the first dose of study medication.
- Progressive disease during or after oral investigational drug treatment.
- Use of any investigational drug within 30 days before starting study treatment. Less than 30 days since the use of any other investigational drug or device.
- Known allergy to any component of the study drug.
About this study
Official title: Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With Metronomic Chemotherapy of Vinorelbine, Cyclophosphamide and Capecitabine (VEX) Regime in Advanced Triple-negative Breast Cancer: a Multicenter, Randomized, Phase II Study
In recent years, immune therapy has significantly altered the treatment landscape for various malignant tumors, including breast cancer. Apart from its direct cytotoxic effects on tumor cells, metronomic chemotherapy has the potential to modulate the immune microenvironment, thereby demonstrating substantial synergistic potential with immune therapy. In a previous prospective adaptive randomized phase II clinical trial, we identified a promising regimen involving PD-1 monoclonal antibody in combination with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy. Building on this foundation, we plan to conduct a multicenter, randomized, controlled phase II study to evaluate the efficacy and safety of the PD-L1 monoclonal antibody in combination with VEX metronomic chemotherapy for patients with advanced triple-negative breast cancer, aiming to provide crucial evidence to guide medication for patients in advanced stages. The control group will receive metronomic oral vinorelbine 20 mg every other day + cyclophosphamide 50 mg daily + capecitabine 500 mg three times daily. The experimental group will receive additional PD-L1 inhibitor adebrelimab at a dose of 1200 mg via intravenous infusion every three weeks. Each cycle consists of three weeks, with imaging examinations conducted every six weeks (two cycles) to assess treatment efficacy. Subjects will continue medication until imaging indicates disease progression, toxicity becomes intolerable, withdrawal of informed consent, or the investigator deems it necessary to terminate medication. Evaluation will include efficacy indicators such as median progression-free survival, safety indicators like drug-related adverse reactions, patient survival quality, along with an exploratory analysis of biomarkers potentially associated with efficacy.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Being tested
- Adebrelimab, Vinorelbine, Cyclophosphamide (tablet), Capecitabine
- Keywords
- PD-L1 inhibitor, immunotherapy, metronomic chemotherapy
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Adebrelimab at a dose of 1200 mg via intravenous infusion every three weeks. Adebrelimab will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
VinorelbineDrug
Metronomic oral vinorelbine 20 mg every other day. Vinorelbine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
Cyclophosphamide (tablet)Drug
Metronomic oral cyclophosphamide 50 mg daily. Cyclophosphamide will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
CapecitabineDrug
Metronomic oral capecitabine 500 mg three times daily. Capecitabine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| adebrelimab + VEX | Experimental | Adebrelimab at a dose of 1200 mg via intravenous infusion every three weeks, in combination with metronomic oral vinorelbine 20 mg every other day + cyclophosphamide 50 mg daily + capecitabine 500 mg three times daily Receives: Drug: Adebrelimab; Drug: Vinorelbine; Drug: Cyclophosphamide (tablet); Drug: Capecitabine |
| VEX | Active comparator | Metronomic oral vinorelbine 20 mg every other day + cyclophosphamide 50 mg daily + capecitabine 500 mg three times daily Receives: Drug: Vinorelbine; Drug: Cyclophosphamide (tablet); Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Measured from the date of study drugs start to the date of the first objective disease progression or death.
Measured: 24 months
Secondary outcomes (5)
Overall Survival
Defined as the duration of time from start of treatment to time of death.
Measured: 24 months
Disease Control Rate
Defined as the percentage of complete response (CR), partial response (PR) or stable Disease (SD). Response will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1.
Measured: 6 weeks of treatment
Objective Response Rate
The objective response rate (ORR) will be defined as the proportion of patients described on the efficacy-evaluable population) who achieve complete response (CR) or partial response (PR) as best overall response at 6 weeks of treatment. ORR is based on tumor assessments.
Measured: 6 weeks of treatment
Duration of Response
The length of time that a patient's disease remains in complete or partial remission after a response to treatment.
Measured: 24 months
Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start19 Jan 2024 (estimated)
- Primary completion19 Jan 2025 (estimated)
- Study completion19 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229067
- Sponsor's protocol ID
- NCC4279
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 29 Jan 2024
- 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 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With Metronomic Chemotherapy of Vinorelbine, Cyclophosphamide and Capecitabine (VEX) Regime in Advanced Triple-negative Breast Cancer: a Multicenter, Randomized, Phase II Study
- ClinicalTrials.gov ID
- NCT06229067
- Acronym / sponsor ID
- NCC4279
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Keywords
- PD-L1 inhibitor, immunotherapy, metronomic chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 19 Jan 2024 (estimated)
- Primary completion
- 19 Jan 2025 (estimated)
- Study completion
- 19 Jan 2027 (estimated)
- First posted
- 29 Jan 2024 (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.
In recent years, immune therapy has significantly altered the treatment landscape for various malignant tumors, including breast cancer. Apart from its direct cytotoxic effects on tumor cells, metronomic chemotherapy has the potential to modulate the immune microenvironment, thereby demonstrating substantial synergistic potential with immune therapy. In a previous prospective adaptive randomized phase II clinical trial, we identified a promising regimen involving PD-1 monoclonal antibody in combination with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy. Building on this foundation, we plan to conduct a multicenter, randomized, controlled phase II study to evaluate the efficacy and safety of the PD-L1 monoclonal antibody in combination with VEX metronomic chemotherapy for patients with advanced triple-negative breast cancer, aiming to provide crucial evidence to guide medication for patients in advanced stages. The control group will receive metronomic oral vinorelbine 20 mg every other day + cyclophosphamide 50 mg daily + capecitabine 500 mg three times daily. The experimental group will receive additional PD-L1 inhibitor adebrelimab at a dose of 1200 mg via intravenous infusion every three weeks. Each cycle consists of three weeks, with imaging examinations conducted every six weeks (two cycles) to assess treatment efficacy. Subjects will continue medication until imaging indicates disease progression, toxicity becomes intolerable, withdrawal of informed consent, or the investigator deems it necessary to terminate medication. Evaluation will include efficacy indicators such as median progression-free survival, safety indicators like drug-related adverse reactions, patient survival quality, along with an exploratory analysis of biomarkers potentially associated with efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adebrelimab + VEX | Experimental | Drug: Adebrelimab, Drug: Vinorelbine, Drug: Cyclophosphamide (tablet), Drug: CapecitabineAdebrelimab at a dose of 1200 mg via intravenous infusion every three weeks, in combination with metronomic oral vinorelbine 20 mg every other day + cyclophosphamide 50 mg daily + capecitabine 500 mg three times daily |
| VEX | Active comparator | Drug: Vinorelbine, Drug: Cyclophosphamide (tablet), Drug: CapecitabineMetronomic oral vinorelbine 20 mg every other day + cyclophosphamide 50 mg daily + capecitabine 500 mg three times daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Female participants aged ≥18 years who have signed informed consent and have an expected survival of ≥3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2 within 21 days prior to the first dose of medication.
- Participants with clear clinical records of metastatic triple-negative breast cancer, as specified in the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.
- Participants with metastatic breast cancer who have received no more than first-line chemotherapy.
- Participants with at least one measurable lesion, as defined by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Key exclusion criteria (20 listed)
- Current or past history of malignancies other than breast cancer, excluding: cured non-melanoma skin cancer, cured cervical carcinoma in situ, or cured other primary solid tumors with no evidence of disease activity and no curative treatment within the last 3 years.
- Solely having pleural effusion, ascites, bone metastases, or other unmeasurable lesions.
- Malabsorption syndrome or diseases significantly affecting gastrointestinal function, prior gastrectomy, or resection of the proximal small intestine that may affect the absorption of oral chemotherapeutic agents.
- Swallowing difficulties or inability to swallow tablets.
- Symptomatic brain or leptomeningeal metastasis; suspected signs or symptoms of central nervous system (CNS) involvement should be excluded by CT or MRI scans.
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 |
|---|---|---|
| AdebrelimabAdebrelimab at a dose of 1200 mg via intravenous infusion every three weeks. Adebrelimab will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. | Drug | adebrelimab + VEX |
| VinorelbineMetronomic oral vinorelbine 20 mg every other day. Vinorelbine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. | Drug | VEX, adebrelimab + VEX |
| Cyclophosphamide (tablet)Metronomic oral cyclophosphamide 50 mg daily. Cyclophosphamide will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. | Drug | VEX, adebrelimab + VEX |
| CapecitabineMetronomic oral capecitabine 500 mg three times daily. Capecitabine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. | Drug | VEX, adebrelimab + VEX |
Primary outcome
Progression-free Survival
Time frame: 24 months
Measured from the date of study drugs start to the date of the first objective disease progression or death.
5 secondary outcomes
Overall Survival
Time frame: 24 months
Disease Control Rate
Time frame: 6 weeks of treatment
Objective Response Rate
Time frame: 6 weeks of treatment
Duration of Response
Time frame: 24 months
Adverse Events
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab, Vinorelbine and Cyclophosphamide (tablet) in people with Breast Cancer and Triple Negative Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 23 inclusion and 20 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: opening soon, as of the sponsor's last update on 29 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: 24 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 29 Jan 2024.