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Breast CancerPhase 2NCT05556200

A Phase II Trial of Camrelizumab in Combination With Apatinib for Neoadjuvant Treatment of Early-stage TNBC With a High Proportion of TILs

A Phase 2 study testing Anti-PD-1 monoclonal antibody and VEGFR2 Tyrosine Kinase Inhibitor in people with Breast Cancer and Triple-Negative Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with apatinib (a VEGFR2 TKI) for neoadjuvant treatment of patients with triple-negative breast cancer and >10% tumor-infiltrating lymphocytes (TILs) in baseline… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer, Triple-Negative Breast Cancer
What is being tested?
Anti-PD-1 monoclonal antibody and VEGFR2 Tyrosine Kinase Inhibitor
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
4 sitesChina
Study dates
1 Dec 2022to 1 Sep 2025
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients sign the written informed consent.
  • Women aged 18-70.
  • Patients with histologically confirmed operable invasive breast cancer (T1cN1-2 or T2-4N0-2)［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］.
  • Percentage of tumor-infiltrating lymphocytes >10% in baseline breast tumor.
  • Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
  • No previous breast cancer-related treatment, including chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy.
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  • Patients can swallow pills.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  • Patients with a life expectancy of at least 12 weeks.
  • The patient's blood test results prior to enrollment met the following criteria： • Hb≥90g/L; • Plt≥100^9/L; • Serum albumin ≥3g/dL; • Neutrophils≥1.5^9/L;
  • TSH≤ normal upper limit (ULN);
  • ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN);
  • TBIL ≤ULN (total bilirubin ≤1.5 ULN in Gilbert's syndrome or liver metastasis subjects);
  • ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN);
  • AKP≤ 2.5 ULN;
  • Renal function within 7 days before the first administration: serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min.
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 6 months after the last dose of study treatment.

Who cannot join

  • Combination of other malignancies or previous malignancies other than breast cancer within the last 5 years, except for basal cell carcinoma or flat cell carcinoma of the skin or carcinoma in situ of the uterine cervix that has been adequately controlled by treatment.
  • Those who are not suitable for immunotherapy in combination with active infection.
  • The combination of severe non-malignant disease that would affect patient compliance or put the patient at risk.
  • Concomitant with other antineoplastic therapy or are participating in other clinical trials.
  • Male breast cancer, bilateral breast cancer or inflammatory breast cancer.
  • Patients with dementia, mental abnormality or any mental illness that prevents understanding of the informed consent form.
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  • Patients with history of allergic reaction or contraindication to the use of any drug component of this trial.
  • Patients with any active autoimmune disease or a history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or whose asthma has completely resolved in childhood and does not require any intervention in adulthood may be included; (Patients with asthma that requires medical intervention with bronchodilators cannot be included).
  • Have cardiac clinical symptoms or disease that are not well controlled, such as:
  • NYHA class 2 or higher heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
  • 10. Urine routine suggestive of urine protein ≥++, or confirmed 24-hour urine protein amount ≥1.0g.
  • 11. Known presence of hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.).
  • 12. Patients with congenital or acquired immune deficiencies (e.g., HIV-infected individuals).
  • 13. Live vaccines administered less than 4 weeks prior to study drug administration or possibly during the study.
  • 14. Active tuberculosis. 15. Patients have received oral or intravenous antibiotic therapy within 2 weeks prior to neoadjuvant therapy.
  • 16. Major surgical procedure within 4 weeks prior to the start of study treatment or anticipated need for major surgical procedure during the course of the study.

Trial locations and contacts

4 sites in 1 country.

Jieqiong Liu, MD,PhD contact

020-34071156

liujieqiong01@163.com

China4 sites, 4 recruiting

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510120

    Jieqiong Liu, M.D., Ph.D.

    Recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Wenbin Zhou, M.D., Ph.D., zhouwenbin@njmu.edu.cn

    Recruiting

  • Second Military Medical University

    Shanghai, Shanghai Municipality, 200433

    Hengyu Li, M.D., Ph.D., lhy@smmu.edu.cn

    Recruiting

  • Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University

    Shanwei, Guangdong, 516600

    Yandan Yao, M.D., Ph.D., yaoyand@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

This is a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with apatinib (a VEGFR2 TKI) for neoadjuvant treatment of patients with triple-negative breast cancer and >10% tumor-infiltrating lymphocytes (TILs) in baseline breast tumors. We will enroll 58 subjects (Simon's two stage design). The study is designed to evaluate the efficacy and safety of camrelizumab in combination with apatinib in the neoadjuvant treatment of TNBC with a high proportion of TILs.

Read the detailed description

This a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial to assess the efficacy and safety of camrelizumab combination with apatinib in female patients age of 18 to 70 with TNBC, and baseline tumor-infiltrating lymphocytes > 10%. The number of patients to be included is 58 patients (Simon's two stage design). The primary objective is to assess the pCR. All enrolled patients will be treated with camrelizumab 200mg (iv. 3mg/kg for patient whose weight is below 50kg) on day 1 of each 21-day cycle, and apatinib 250mg daily (po, d1-d21).

Being tested
Anti-PD-1 monoclonal antibody, VEGFR2 Tyrosine Kinase Inhibitor
Keywords
anti-PD-1 antibody, VEGFR2 TKI
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.

  • Anti-PD-1 monoclonal antibodyDrug

    Also called Camrelizumab

    Camrelizumab 200 mg, iv, d1, q3W (3 mg/kg if weight <50 kg)

  • VEGFR2 Tyrosine Kinase InhibitorDrug

    Also called Apatinib

    Apatinib 250 mg, po, qd

Study groups in NCT05556200
Study groupRoleWhat they receive
ExperimentExperimentalEligible patients enrolled receive camrelizumab 200 mg, iv, d1, every 21 days (3 mg/kg if weight <50 kg) in combination with apatinib 250 mg, po, qd for neoadjuvant treatment for 8 cycles. Patients evaluated after neoadjuvant therapy with pCR receive 9 cycles of postoperative adjuvant camrelizumab (200 mg, iv, or 3 mg/kg if weight <50 kg, d1,q3W) + apatinib (250 mg, po, qd). Patients with non-pCR after neoadjuvant therapy receive adjuvant chemotherapy of the physician's choice (TPC).
Receives: Drug: Anti-PD-1 monoclonal antibody; Drug: VEGFR2 Tyrosine Kinase Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Remission (pCR) rate

    pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.

    Measured: After neoadjuvant study treatment and surgery, up to approximately 24-26 weeks

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    The propotion of subjects with CR or PR according to RECIST v1.1.

    Measured: After neoadjuvant study treatment and surgery, up to approximately 24-26 weeks

  2. Breast Conservation Rate

    The percentage of patients who undergo breast-conserving surgery after neo-adjuvant therapy.

    Measured: Up to approximately 24-26 weeks

  3. Incidence of Treatment-Emergent Adverse Events

    Adverse events/serious adverse events.

    Measured: From the first drug administration to within 90 days for the last dose

  4. Event-Free Survival (EFS)

    Event-free survival (EFS) defined as the time from recruitment until documented disease recurrence, progression, or death from any cause in all participants. EFS events covered under "disease recurrence" will include local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers will not be counted as EFS events.

    Measured: Up to approximately 8 years

  5. Overall Survival (OS)

    defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 8 years

  6. Frequencies of Biomarkers

    Biomarkers (including tumor/stromal PD-L1, stromal PD-1, tumor-infiltrating lymphocytes and tumor-infiltrating B cells, eg).

    Measured: Up to approximately 24-26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2022
  2. Study start1 Dec 2022
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

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
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05556200
Sponsor's protocol ID
NeoCAT
Status last verified
Apr 2023
First submitted
24 Sep 2022
Last updated
12 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Tian Z, Li H, Deng Y, Yao H, Wang Y, Jin L, Deng H, Chen N, Liu J. Efficacy, safety, and biomarker analysis of neoadjuvant camrelizumab plus apatinib as a chemotherapy-free strategy for early-stage triple-negative breast cancer: a phase II study. Breast Cancer Res Treat. 2026 Aug 31;219(2):3. doi: 10.1007/s10549-026-08066-5.

    PubMed 42671642

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti-PD-1 monoclonal antibody and VEGFR2 Tyrosine Kinase Inhibitor in people with Breast Cancer and Triple-Negative Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites in China.

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 17 inclusion and 16 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Jieqiong Liu, MD,PhD (020-34071156, liujieqiong01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Remission (pCR) rate (time frame: After neoadjuvant study treatment and surgery, up to approximately 24-26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05556200, which also lists 1 linked publication.

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 Apr 2023.

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