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Triple-negative Breast CancerPhase 1/2NCT04213898

SHR-1210 Combined With Albumin-bound Paclitaxel and Epirubicin Neoadjuvant for Triple Negative Breast Cancer

A Phase 1/2 study testing SHR-1210+Albumin-bound paclitaxel + epirubicin in people with Triple-negative Breast Cancer, run by Henan Cancer Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Triple negative breast cancer (TNBC), characterized by estrogen receptor, progesterone receptor and HER2 negative, accounts for 10-20% of all breast cancers and usually occurs in young women. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Triple-negative Breast Cancer
What is being tested?
SHR-1210+Albumin-bound paclitaxel + epirubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
No sites listed yet
Study dates
Jan 2020to Jan 2023
Phase
Phase 1/2
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 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 1. Newly treated female patients aged ≥18 years and ≤60 years; 2. ECOG score 0 ~ 1 points; 3. Pathologically confirmed, the core biopsy of breast tumor lesions identified patients with TNBC breast cancer; Note: ER and PR negatives are defined as ≤ 10% of cells expressing hormone receptors by IHC (immunohistochemistry) analysis. HER2 (human epidermal growth factor receptor 2) negative is defined as any of the following assessments: non-amplified in situ hybridization (ISH) (ratio ≤ 2.2), or IHC 0 or IHC 1+; 4. Evaluate measurable tumor lesions by ultrasound or magnetic resonance imaging (MRI) within 21 days before enrollment, size ≥2cm; 5. The main organs function normally, that is, they meet the following criteria:
  • Blood routine examination standards must meet: ANC ≥1.5 × 109 / L; PLT ≥90 × 109 / L; Hb ≥90g / L;
  • Biochemical examination must meet the following standards: TBIL ≤ upper limit of normal value (ULN); ALT and AST ≤ 1.5 times the upper limit of normal value (ULN); alkaline phosphatase ≤ 2.5 times the upper limit of normal value (ULN); BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥50 mL / min (CockcroftGault formula);
  • The coagulation test standard must meet: the international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN, and the activated partial thromboplastin time (aPTT) ≤ 1.5x ULN;
  • Color Doppler ultrasound and echocardiography: left ventricular ejection fraction (LVEF≥55%);
  • 18-lead electrocardiogram Fridericia-corrected QT interval (QTcF) for women <470 ms; 6. No evidence of distant metastases, including bilateral mammograms, breast ultrasounds; 7. Provide core biopsies from tumor lesions before treatment begins to confirm TNBC status and biomarker analysis; 8. For women who are not menopausal or not undergoing surgical sterilization: agree to abstinence or use an effective method of contraception during treatment and at least 7 months after the last dose during study treatment; 9. Sign the informed consent.

Who cannot join

  • 1. Inflammatory breast cancer or stage IV (metastatic) breast cancer; 2. Have previously been treated with anti-PD-1, anti-PD-L1, anti-PD-L2 drugs or drugs that target another co-inhibitory T cell receptor (eg CTLA-4, OX-40, CD137); 3． Have previously received antitumor treatment or radiation therapy for any malignant tumor, excluding cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; 4． Also receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphate therapy or immunotherapy; 5. Have undergone major breast cancer-free surgery within 4 weeks before enrollment, or the patient has not fully recovered from such surgery; 6. Severe heart disease or discomfort, including but not limited to the following:
  • --A history of diagnosis of heart failure or systolic dysfunction (LVEF <50%)
  • High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate> 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular block (ie Mobitz II second-degree atrioventricular block or third-degree atrioventricular block)
  • --Angina pectoris requiring antianginal medication
  • Clinically significant heart valve disease
  • --ECG shows transmural myocardial infarction
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  • Poorly controlled hypertension (systolic blood pressure> 180 mmHg and / or diastolic blood pressure> 100 mmHg); 7. Have an autoimmune disease or other disease that requires systemic treatment with corticosteroids or immunosuppressive drugs (physical corticosteroid replacement therapy that allows adrenal or pituitary insufficiency); 8. A history of primary or acquired immunodeficiency (including allograft transplantation); 9. Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraception during the entire trial and within 7 months after the last study medication; 10. have a history of (non-infectious) pneumonia, or currently have pneumonia that requires steroid therapy; 11. Active or previously documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis); 12. Known medical history of the following infections:
  • Human Immunodeficiency Virus (HIV)
  • A history of acute or chronic hepatitis B or C
  • Received live virus vaccine within 30 days of planned start of treatment. Allow use of seasonal influenza vaccines that do not contain live viruses; 13. People with a known history of allergies to the drug components of this program; a history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 14. Suffering from a serious concomitant disease or other comorbid condition that interferes with the planned treatment, or any other condition that the investigator considers the patient unsuitable to participate in this study.

Trial locations and contacts

No sites are listed yet.

Chengzheng Wang contact

13803711526

13724085853@163.com

About this study

Triple negative breast cancer (TNBC), characterized by estrogen receptor, progesterone receptor and HER2 negative, accounts for 10-20% of all breast cancers and usually occurs in young women. It is an aggressive and worst prognosis breast cancer subtype, which urgently requires effective treatment.The pathological complete response (pCR) of neoadjuvant therapy is associated with disease-free survival (DFS) and overall survival (OS) of breast cancer. The correlation between pathological response and long-term survival in patients with early-stage breast cancer is the strongest among patients with triple-negative breast cancer.

Being tested
SHR-1210+Albumin-bound paclitaxel + epirubicin
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.

  • SHR-1210+Albumin-bound paclitaxel + epirubicinDrug

    Also called camrelizumab for injection

    Neoadjuvant therapy：SHR-1210, 200mg,iv, q3w, for 6 cycles; Albumin-bound paclitaxel: 125 mg/m2, iv, d1, d8, and d15, 21 days as a cycle, for 6 cycles; Epirubicin: 75mg / m2, iv, d1, 21 days as a cycle, for 6 cycles; The surgery was performed 3-4 weeks after the completion of neoadjuvant chemotherapy.

Study groups in NCT04213898
Study groupRoleWhat they receive
SHR-1210+Albumin-bound paclitaxel+EpirubicinExperimentalNeoadjuvant therapy：SHR-1210+Albumin-bound paclitaxel+Epirubicin
Receives: Drug: SHR-1210+Albumin-bound paclitaxel + epirubicin

What is being measured

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

  1. Pathological Complete Response (pCR)

    TpCR (ypT0 / is, ypN0) assessed by pathologists participating in the research center: defined as the pathological evaluation of hematoxylin and eosin-stained resected breast cancer samples and all ipsilateral lymph node samples after neoadjuvant therapy and surgery there is any residual invasive cancer.

    Measured: At time of surgery

Secondary outcomes (2)

  1. Disease-free survival (DFS)

    Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death Defined as the time interval from the first day of disease-free (ie, the date of surgery) to the first recording of related events, which include recurrence of postoperative disease and death from any cause

    Measured: up to 2 year

  2. Objective Response Rate (ORR)

    CR+PR

    Measured: up to 1 year

Timeline

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

  1. First posted30 Dec 2019
  2. Study startJan 2020 (estimated)
  3. Primary completionJan 2021 (estimated)
  4. Study completionJan 2023 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04213898
Sponsor's protocol ID
HR-TNBC-HN100
Status last verified
Dec 2019
First submitted
27 Dec 2019
Last updated
30 Dec 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-1210+Albumin-bound paclitaxel + epirubicin in people with Triple-negative Breast Cancer, run by Henan Cancer Hospital.

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 6 inclusion and 10 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 30 Dec 2019. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Chengzheng Wang (13803711526, 13724085853@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR) (time frame: At time of surgery). 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 NCT04213898.

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 30 Dec 2019.

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