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Breast CancerPhase 2NCT05097248

Camrelizumab in Combination With PLD and Losartan in Patients With TNBC Who Have Received ≦ 1 Line of Chemotherapy

A Phase 2 study testing Camrelizumab, Liposomal Doxorubicin and Losartan in people with Breast Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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, single-arm, multi-center, prospective clinical study of camrelizumab in combination with liposomal doxorubicin and losartan in patients with advanced or locally advanced triple-negative breast cancer who had received no more than 1 prior line of chemotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Camrelizumab, Liposomal Doxorubicin and Losartan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
Oct 2021to Oct 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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women aged 18-70.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］. Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
  • With a life expectancy of at least 12 weeks.
  • The cumulative dose of prior doxorubicin and epirubicin should not exceed 300 mg/m2 and 600 mg/m2, respectively, with randomization > = 12 months since last treatment.
  • Previously treated with no more than one line of chemotherapy in the advanced setting.
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  • PD-L1 positive, CPS score ≥ 1.
  • At least one measurable lesion according to RECIST 1.1;
  • The functional level of major organs must meet the following requirements:
  • blood routine: neutrophil (ANC)≥1.5×10^9/L; platelet count (PLT)≥90×10^9/L; hemoglobin (Hb) ≥90 g/L;
  • blood biochemistry: total bilirubin (TBIL)≤upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; alkaline phosphatase ≤ 2.5×ULN; blood urea nitrogen (BUN) and creatinine (Cr)≤1.5×ULN;
  • coagulation: international normalized ratio (INR) or prothrombin time (PT)≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5×ULN.
  • Heart: left ventricular ejection fraction (LVEF)≥50% as assessed by echocardiography (ECHO) or multigated acquisition (MUGA).
  • Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be investigated, and normal T3 and T4 levels can be included.
  • 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.
  • The patient can swallow pills.
  • The patients sign the written informed consent.

Who cannot join

  • The subjects had a central nervous system metastases with clinical symptoms.
  • Other clinical trials of drugs were used in the first four weeks before the first dose.
  • Subjects with severe allergic reactions to other monoclonal antibodies.
  • Received other anti-tumor treatments within 28 days before the first dose.
  • A heart condition or disease that is not well controlled.
  • Subjects with treatment history of anti-angiogenesis drugs, or immunotherapy (previous use of anti-PD-1/PD-L1 antibodies was allowed) or eribulin.
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  • The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
  • Subjects had history of hypertension and poor control with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥100 mmHg)；
  • Subjects must not have baseline hypotension, defined as systolic blood pressure less than 100 mmHg in both readings taken 2 days prior to the study.
  • Urine routine indicated that urine protein ≥ ++, or the 24-hour urine protein quantity ≥ 1.0g.
  • Hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.).
  • Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B indicates antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method).
  • Receive live vaccine within 4 weeks before or during the study period;
  • Patients who are allergic to or contraindicated to the experimental drugs.
  • Concurrent medical conditions that, in the judgment of the investigator, would jeopardize the subject's safety, could confound the study results, or affect the subject's completion of this study.

Trial locations and contacts

1 site in 1 country.

Yanxia Zhao, M.D. contact

13407192551

sophia7781@126.com

China1 site

  • Union Hospital, Tongji Medical College of HUST

    Wuhan, Hubei, 430000

    Yanxia Zhao, M.D.

Other trials in China

About this study

Official title: Camrelizumab Combined With Liposomal Doxorubicin and Losartan in the Treatment With Advanced or Locally Advanced Triple-negative Breast Cancer Who Have Received no More Than 1 Prior Line of Chemotherapy

This is a phase II, single-arm, multi-center, prospective clinical study of camrelizumab in combination with liposomal doxorubicin and losartan in patients with advanced or locally advanced triple-negative breast cancer who had received no more than 1 prior line of chemotherapy. Our aim was to explore the efficacy and safety of it.

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 liposomal doxorubicin and losartan in female patients age of 18 to 70 with advanced or locally advanced TNBC, and previously treated with no more than one line of chemotherapy in the advanced setting. The number of patients to be included is 52 patients (Simons two stage design). 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 liposomal doxorubicin (40 mg, Q3W for 6 weeks) plus oral losartan (50 mg loading dose followed by 100 mg QD, Q3W, until discontinuation of liposomal doxorubicin).The primary objective is to assess the overall response rate (ORR).

Conditions
Breast Cancer
Being tested
Camrelizumab, Liposomal Doxorubicin, Losartan
Medical subject headings
Breast Neoplasms

What participants receive

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

  • CamrelizumabDrug

    Camrelizumab 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every three weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.

  • Liposomal DoxorubicinDrug

    Liposomal Doxorubicin 40 mg/m2 on D1 every 3 weeks; 6 cycles are planned to be completed or discontinued due to intolerable toxicity or progression.

  • LosartanDrug

    Losartan will be orally administered at 50 mg for three days and increased to 100 mg if tolerated until the whole course of chemotherapy; if not tolerated, it will be maintained at 50 mg until the whole course of chemotherapy

Study groups in NCT05097248
Study groupRoleWhat they receive
Camrelizumab, Liposomal doxorubicin and LosartanExperimentalParticipants receive intravenous camrelizumab (200 mg, Q3W) and liposomal doxorubicin (40 mg, Q3W for 6 weeks) plus oral losartan (50 mg loading dose followed by 100 mg QD, Q3W, until discontinuation of liposomal doxorubicin).
Receives: Drug: Camrelizumab; Drug: Liposomal Doxorubicin; Drug: Losartan

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Measured: Estimated 12 months

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: Estimated 12 months

  2. Overall Survival (OS)

    Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication and participants with no post-baseline information were censored at the date of randomization.

    Measured: Estimated 24 months

  3. Duration of Response (DoR)

    DoR is defined as date of initial confirmed PR/CR until date of progressive disease or death from any cause. PR or CR or SD is according to RECIST version 1.1.

    Measured: Estimated 12 months

  4. Clinical Benefit rate (CBR)

    Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects

    Measured: Estimated 12 months

  5. Adverse events (AEs)

    AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.3.

    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: Estimated 12 months

Timeline

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

  1. First posted28 Oct 2021
  2. Study startOct 2021 (estimated)
  3. Primary completionOct 2024 (estimated)
  4. Study completionOct 2024 (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
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05097248
Sponsor's protocol ID
WHUH-BC-001
Status last verified
Oct 2021
First submitted
11 Oct 2021
Last updated
28 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Liposomal Doxorubicin and Losartan in people with Breast Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 17 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: status not confirmed, as of the sponsor's last update on 28 Oct 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yanxia Zhao, M.D. (13407192551, sophia7781@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Estimated 12 months). 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 NCT05097248.

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 28 Oct 2021.

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