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Triple Negative Breast CancerPhase 2NCT05447702

Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)

A Phase 2 study testing Camrelizumab, Apatinib and Nab-paclitaxel in people with Triple Negative Breast Cancer, run by West China Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of camrelizumab in combination with apatinib and chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC). Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Camrelizumab, Apatinib and Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
1 Nov 2022to 31 Dec 2026
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed breast cancer.
  • 18-75 Years, female.
  • Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
  • Tumor stage: II-III.
  • ECOG Performance Status of 0-1.
  • life expectancy is not less than 3 months.
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  • at least one measurable lesion according to RECIST 1.1.
  • Adequate hematologic and organ function.
  • Must be willing to use an adequate method of contraception for the course of the study.

Who cannot join

  • Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer.
  • Inflammatory breast cancer.
  • Has received prior any anti-tumor therapy within the past 12 months prior to signing informed consent, including chemotherapy, targeted therapy, radiation therapy, immunotherapy, biotherapy and TAE.
  • Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4], and/or anti-VEGFR agent.
  • Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  • Major surgical procedure within 4 weeks prior to initiation of study treatment.
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  • Has a history of autoimmune disease.
  • Has a history of hypertension that not well controlled by antihypertensive treatment
  • Has a history of myocardial infarction, severe/unstable angina pectoris, NYHA Class 2 or above cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, or symptomatic congestive heart failure within the last 6 months.
  • Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases.
  • Administration of a live attenuated vaccine within 28 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study.
  • Has a known history of Human Immunodeficiency Virus (HIV).
  • Has known active Hepatitis B, Hepatitis C or Autoimmune hepatitis.
  • Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment.
  • Has evidence of active tuberculosis within 1 year prior to initiation of study treatment.
  • Prior allogeneic stem cell or solid organ transplantation.
  • Peripheral neuropathy grade ≥2.
  • Has clinically significant intestinal obstruction.
  • Arterial/venous thrombosis events that occurred within 3 months before enrollment, such as cerebrovascular accidents, deep vein thrombosis, or pulmonary embolism.
  • Has hemoptysis symptoms within 2 months before enrollment and the maximum daily hemoptysis ≥ 2.5 ml.
  • Clinically significant bleeding symptoms or clear bleeding tendency occurred within 3 months before enrollment.
  • Has known genetic or acquired bleeding or thrombotic tendency.
  • Abnormal coagulation (INR>1.5 or APTT>1.5 x ULN) with bleeding tendency, receiving thrombolysis or anticoagulation therapy, or requiring long-term antiplatelet therapy.
  • Has a known hypersensitivity to the components of the study treatment or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  • Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial.
  • History of neurological or psychiatric disorders, including epilepsy or dementia.
  • Any other situation evaluated by researchers.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ting Luo, MD contact

+86 18602866299

tina621@163.com

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Ting Luo, MD, +86 18602866299, tina621@163.com

    Ting Tuo, MD

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Prospective Phase II Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer (TNBC)

The purpose of this study is to evaluate the efficacy and safety of camrelizumab in combination with apatinib and chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC).

Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05447702
Study groupRoleWhat they receive
Camrelizumab + Apatinib + ChemotherapyExperimentalParticipants received neoadjuvant therapy with four 4-week cycles of camrelizumab (200 mg, q2w) plus apatinib (250 mg, qd) and nab-paclitaxel (125 mg/m2, qw), followed by four 2-week cycles of camrelizumab (200 mg, q2w) plus apatinib (250 mg, qd) and epirubicin (90 mg/m2, q2w) + cyclophosphamide (600 mg/m2, q2w).
Receives: Drug: Camrelizumab; Drug: Apatinib; Drug: Nab-paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide

What is being measured

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

  1. pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery

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

    Measured: Up to approximately 28 weeks

Secondary outcomes (5)

  1. pCR rate using the definition of ypT0/Tis (i.e., absence of invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement) at the time of definitive surgery

    pCR rate (ypT0/Tis) is defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants.

    Measured: Up to approximately 28 weeks

  2. Objective Response Rate (ORR)

    ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until definitive surgery or disease progression.

    Measured: Up to approximately 28 weeks

  3. Event-Free Survival (EFS)

    EFS is defined as the time from start of study treatment to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.

    Measured: Up to approximately 3 years

  4. Invasive Disease-Free Survival (iDFS)

    iDFS events are defined as follows: (1) Ipsilateral invasive breast tumor recurrence. (2) Ipsilateral local-regional invasive breast cancer recurrence. (3) Ipsilateral second primary invasive breast cancer. (4) Contralateral invasive breast cancer. (5) Distant recurrence. (6) Death attributable to any cause.

    Measured: Up to approximately 3 years

  5. Adverse events (AEs)

    AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

    In general, AEs are graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE.

    The type, grade and frequency of AEs will be reported.

    Measured: Up to approximately 37 weeks

Timeline

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

  1. First posted7 Jul 2022
  2. Study start1 Nov 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2026 (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
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05447702
Sponsor's protocol ID
MA-BC-II-026
Status last verified
May 2023
First submitted
30 Jun 2022
Last updated
22 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu X, Zhuang C, Liu L, Xiong L, Xie X, He P, Li J, Wei B, Yan X, Tian T, Zhong X, Chen J, Cheng Y, Zheng D, Cheng P, Sun T, Li W, Zhu C, Chen S, Fang C, Fu J, Li S, Jing J, Luo T. Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis. Signal Transduct Target Ther. 2025 Jul 21;10(1):237. doi: 10.1038/s41392-025-02337-1.

    PubMed 40691458

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Apatinib and Nab-paclitaxel in people with Triple Negative Breast Cancer, run by West China Hospital at 1 site 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 9 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

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?

Contact Ting Luo, MD (+86 18602866299, tina621@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery (time frame: Up to approximately 28 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 NCT05447702, 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 22 May 2023.

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