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Breast Cancer Stage IVPhase 3NCT06889688

Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer

A Phase 3 study testing Camrelizumab+Apatinib+Eribulin and Physician's choice chemotherapy in people with Breast Cancer Stage IV and Triple -Negative Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 7 sites 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

This study evaluates the efficacy and safety of camrelizumab, apatinib, and eribulin versus physician's choice chemotherapy in advanced TNBC.Primary Objectives: Assess improvements in progression-free survival (PFS) and overall survival (OS).Secondary Objectives: Compare objective response rate (ORR), disease control… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Camrelizumab+Apatinib+Eribulin and Physician's choice chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
7 sitesChina
Study dates
21 Feb 2025to 1 Jun 2029
Phase
Phase 3
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject voluntarily agrees to participate in this study and signs an informed consent form (ICF).
  • Female subjects aged ≥18 and ≤70 years on the date of signing the ICF.
  • Pathologically confirmed advanced triple-negative breast cancer (TNBC), defined as ER-negative (IHC ER-positive percentage <1%), PR-negative (IHC PR-positive percentage <1%), and HER2-negative (IHC-/+, or IHC++ but FISH/CISH-), with at least one measurable lesion per RECIST v1.1 criteria.
  • Patients who have received at least 1 and up to 4 lines of prior systemic therapy for metastatic or locally advanced unresectable triple-negative breast cancer (TNBC) with disease progression. Prior systemic therapy (including at least 1 line of chemotherapy and neoadjuvant/adjuvant chemotherapy) must include at least a taxane or anthracycline. Subjects who relapse within 6 months after completion of neoadjuvant/adjuvant chemotherapy are considered as having failed first-line therapy.
  • Capable of swallowing tablets.
  • ECOG performance status of 0-1.
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  • Expected survival ≥12 weeks.
  • Adequate function of vital organs, meeting the following criteria (without the use of blood products or growth factors during the screening period): Absolute neutrophil count (ANC) ≥1.5×10⁹/L. Platelet count ≥100×10⁹/L. Hemoglobin ≥9 g/dL. Serum albumin ≥3 g/dL. Thyroid-stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should be assessed; subjects with normal T3 and T4 levels are eligible). Total bilirubin ≤1.0×ULN (for subjects with Gilbert's syndrome or liver metastases, total bilirubin ≤1.5×ULN). ALT and AST ≤1.5×ULN (for subjects with liver metastases, ≤3×ULN). Alkaline phosphatase (ALP) ≤2.5×ULN. Renal function within 7 days prior to the first dose: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min.
  • Women of childbearing potential agree to use highly effective contraception starting at least 7 days prior to the first dose and continuing for 24 weeks after the last dose. A negative serum pregnancy test is required within 7 days prior to the first dose.

Who cannot join

  • Subjects with untreated active brain metastases or leptomeningeal metastases.
  • Participation in any other interventional clinical trial within 28 days prior to the first dose.
  • History of severe allergic reactions to other monoclonal antibodies.
  • Receipt of other antitumor therapies within 28 days prior to the first dose.
  • Uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
  • Prior treatment with CTLA-4, Tim-3, or LAG-3 antibodies, or T-cell co-stimulatory therapies (previous use of PD-1 or PD-L1 antibodies is allowed).
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  • Prior treatment with anti-angiogenic agents or eribulin chemotherapy.
  • Presence of any active autoimmune disease or a history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism). Subjects with vitiligo, or childhood asthma that has fully resolved without intervention in adulthood, may be included. Subjects with asthma requiring medical intervention with bronchodilators are excluded.
  • Uncontrolled cardiac clinical symptoms or diseases, including: Heart failure classified as NYHA Class II or higher. Unstable angina. Myocardial infarction within the past year. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
  • Urinalysis indicating proteinuria ≥++ or confirmed 24-hour urinary protein ≥1.0 g.
  • Known hereditary or acquired bleeding or thrombotic disorders (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism).
  • Congenital or acquired immunodeficiency (e.g., HIV infection).
  • Receipt of a live vaccine within 4 weeks prior to or during the study period.
  • Allergy or contraindication to the investigational drugs.
  • Underwent surgery within 3 months prior to enrollment or anticipated need for major surgical procedures during the study period.

Trial locations and contacts

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

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

+86-020-34071156

liujieqiong01@163.com

7 sites in 1 country

China7 sites, 7 recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan

    Kejing Zhang, M.D., Ph.D., +86-0731-82650001

    Kejing Zhang, M.D., Ph.D

    Not yet recruiting

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong

    Jieqiong Liu, M.D., Ph.D., +86-020-34071156, liujieqiong01@163.com

    Jieqiong Liu, M.D., Ph.D

    Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

    Shu Liu, M.D., Ph.D., +86-851-86855119

    Shu Liu, M.D., Ph.D

    Recruiting

  • Changhai Hospital of Shanghai

    Shanghai

    Hengyu Li, Dr., +86 21 31166666

    Recruiting

  • Wuhan Union Hospital of China

    Wuhan, Hubei

    Yanxia Zhao, M.D., Ph.D., +86-027-85726114

    Yanxia Zhao, M.D., Ph.D

    Not yet recruiting

  • Yichang Central People's Hospital

    Yichang, Hubei

    Yuyan Tan, M.D., Ph.D., +86-0717-6484621

    Yuyan Tan, M.D., Ph.D

    Recruiting

  • The Central Hospital Of Yong Zhou

    Yongzhou, Hunan

    Sijuan Ding, +86-0746-6565666

    Sijuan Ding, M.D., Ph.D

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Phase III, Randomized Controlled Trial Comparing Camrelizumab Plus Apatinib and Eribulin Versus Physician's Choice Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer

This study evaluates the efficacy and safety of camrelizumab, apatinib, and eribulin versus physician's choice chemotherapy in advanced TNBC.Primary Objectives: Assess improvements in progression-free survival (PFS) and overall survival (OS).Secondary Objectives: Compare objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), duration of response (DoR), time to response (TTR), two-year OS rate, biomarker analysis, and quality of life (QoL).Safety: Assess and compare adverse event incidence and severity.

Read the detailed description

This study aims to evaluate the efficacy and safety of the triplet regimen compared to physician's choice chemotherapy as a later-line treatment for advanced triple-negative breast cancer (TNBC). 1. Primary Objectives and Endpoints: To determine whether the combination of camrelizumab, apatinib, and eribulin improves progression-free survival (PFS) and overall survival (OS) compared to investigator's choice chemotherapy in advanced TNBC. 2. Secondary Objectives and Endpoints: To compare the following clinical parameters between the camrelizumab, apatinib, and eribulin combination and investigator's choice chemotherapy for advanced TNBC: -Objective response rate (ORR) Disease control rate (DCR) Clinical benefit rate (CBR) Duration of response (DoR) Time to response (TTR) Two-year overall survival rate (2-year OS rate) Biomarker analysis Quality of life (QoL) analysis 3.Safety Evaluation: Comparison of the incidence and severity of adverse events between the two groups.

Being tested
Camrelizumab+Apatinib+Eribulin, Physician's choice chemotherapy
Keywords
Advanced Triple-Negative Breast Cancer, Immunotherapy
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.

  • Camrelizumab+Apatinib+EribulinDrug

    Camrelizumab (200 mg, IV, Day 1) + Apatinib (250 mg, PO, QD) + Eribulin (1.4 mg/m², IV, Day 1 and Day 8) administered in 21-day cycles.

  • Physician's choice chemotherapyDrug

    Physician's Choice Chemotherapy

Study groups in NCT06889688
Study groupRoleWhat they receive
Experimental GroupExperimentalCamrelizumab (200 mg, IV, Day 1) + Apatinib (250 mg, PO, QD) + Eribulin (1.4 mg/m², IV, Day 1 and Day 8) administered in 21-day cycles.
Receives: Drug: Camrelizumab+Apatinib+Eribulin
Control GroupActive comparatorPhysician's Choice Chemotherapy
Receives: Drug: Physician's choice chemotherapy

What is being measured

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

  1. Progression-Free Survival

    Disease evaluation will be performed according to RECIST v1.1 criteria.

    Measured: Time from enrollment to the occurrence of predefined events, including disease progression or death, whichever came first, assessed up to 60 months.

  2. Overall Survival

    Death from any cause.

    Measured: From date of randomization until the date of death from any cause, assessed up to 120 months.

Secondary outcomes (7)

  1. Objective Response Rate

    The percentage of patients in different groups whose tumor size reduction, meets the criteria for complete response (CR) or partial response (PR).

    Measured: From date of randomization until the date of first documented CR or PR, whichever came first, assessed up to 12 months.

  2. Disease control rate

    Proportion of patients achieving CR, PR, or stable disease (SD).

    Measured: From date of randomization until the date of first documented CR, PR or SD, assessed up to 12 months.

  3. Clinical Benefit Rate

    Proportion of patients achieving CR, PR, or SD.

    Measured: From date of randomization until the date of first documented CR, PR or SD for more than 6month, assessed up to 18 months.

  4. Duration of Response

    Time from the first assessment showing CR or PR to the first occurrence of progressive disease (PD) or death from any cause.

    Measured: Time from the first assessment showing CR or PR to the first occurrence of PD or death from any cause, whichever came first, assessed up to 120 months.

  5. Time to Response

    Time from randomization to the first occurrence of CR or PR.

    Measured: Time from randomization to the first occurrence of CR or PR, whichever came first, assessed up to 6 months

  6. Two-Year Overall Survival Rate

    Proportion of patients alive two years after randomization.

    Measured: Two years after randomization.

  7. Safety Evaluation

    Comparison of the incidence and severity of adverse events between the two groups.

    Measured: From randomization to 30 days after the last dose of study treatment.

Timeline

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

  1. First posted21 Mar 2025
  2. Study start21 Feb 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion1 Jun 2029 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
246 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06889688
Sponsor's protocol ID
CAPER-III
Status last verified
Apr 2026
First submitted
11 Mar 2025
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Camrelizumab+Apatinib+Eribulin and Physician's choice chemotherapy in people with Breast Cancer Stage IV and Triple -Negative Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 7 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 9 inclusion and 15 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Jieqiong Liu, M.D., Ph.D. (+86-020-34071156, liujieqiong01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: Time from enrollment to the occurrence of predefined events, including disease progression or death, whichever came first, assessed up to 60 months.). The study lists 2 primary outcomes in all. 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 NCT06889688.

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 23 Apr 2026.

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