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Triple Negative Breast CancerPhase 2NCT04676997

Neoadjuvant Study of Camrelizumab Plus Chemotherapy in Triple Negative Breast Cancer (TNBC)

A Phase 2 study testing Camrelizumab, Nab paclitaxel and Epirubicin in people with Triple Negative Breast Cancer, run by Shandong Cancer Hospital and Institute 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The study is being conducted to evaluate the efficacy, safety and tolerability of Camrelizumab Combination With Nab-Paclitaxel and Epirubicin as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Camrelizumab, Nab paclitaxel and Epirubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
20 May 2020to 28 Feb 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

  • Newly diagnosed breast cancer
  • 18-70 Years, female;
  • life expectancy is not less than 3 months
  • Histologically documented TNBC (negative human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PgR] status);
  • Stage at presentation: T1c N1-2 or T2-4 N0-2;
  • at least one measurable lesion according to RECIST 1.1;
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  • Adequate function of major organs meets the following requirements:
  • Neutrophils ≥ 1.5×10^9/L
  • Platelets ≥ 100×10^9/L
  • Hemoglobin ≥ 90g/L
  • lymphocyte≥0.5×10^9/L
  • Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
  • ALT and AST ≤ 3 × ULN
  • ALP≤ 2.5 × ULN
  • BUN and Cr ≤ 1.5 × ULN
  • TSH≤ ULN
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • QTcF ≤ 470 ms
  • Provides tumor tissue specimen to assess tumor programmed death-ligand 1 (PD-L1);
  • For women of childbearing potential: agreement to use contraceptive methods. Women who are not postmenopausal or have undergone a sterilization procedure must have a negative serum pregnancy test result within 72 hours prior to initiation of study drug.

Who cannot join

  • Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer
  • Inflammatory breast cancer
  • patients who received chemotherapy, endocrine therapy, immunotherapy, biotherapy or TACE within 4 weeks before admission
  • Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment
  • Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
  • 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.
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  • Major surgical procedure within 4 weeks prior to initiation of study treatment
  • Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus
  • 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 1year prior to initiation of study treatment
  • Prior allogeneic stem cell or solid organ transplantation
  • Pre-existing motor or sensory neuropathy of a severity≥grade 2
  • Has significant cardiovascular disease
  • Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment
  • 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.

Jinming Yu, MD contact

+8613806406293

jn7984729@public.jn.sd.cn

Yongsheng Wang, MD contact

+8613505409989

wangysh2008@aliyun.com

China1 site, 1 recruiting

  • Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University Recruiting

    Jinan, Shandong, 250117

    Jinming Yu, MD, +8613806406293, jn7984729@public.jn.sd.cn

    Yongsheng Wang, MD, +8613505409989, wangysh2008@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ⅱ Study to Evaluate Efficacy and Safety of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)

The study is being conducted to evaluate the efficacy, safety and tolerability of Camrelizumab Combination With Nab-Paclitaxel and Epirubicin as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)

Keywords
Neoadjuvant, PD-1
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.

  • CamrelizumabBiological

    200mg on days1,15 of Cycles 1-4 (Q2W); IV infusion. 200mg on day 1 of Cycles 5-8 (Q2W); IV infusion.

  • Nab paclitaxelDrug

    125 mg/m² on day 1, 8 and 15 of Cycles 1-4 (QW 3/4); IV infusion.

  • EpirubicinDrug

    90 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.

  • CyclophosphamideDrug

    600 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.

Study groups in NCT04676997
Study groupRoleWhat they receive
Camrelizumab+ChemotherapyExperimentalParticipants receive Camrelizumab d1,15 (Q2W) + nab-paclitaxel d1,8,15(QW 3/4) x 4 cycles, followed by Camrelizumab Q2W + epirubicin + cyclophosphamide Q2W x 4 cycles as neoadjuvant therapy prior to surgery
Receives: Biological: Camrelizumab; 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 27-30 weeks

Secondary outcomes (4)

  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 27-30 weeks

  2. Event-Free Survival (EFS) in all participants

    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 5 years

  3. Objective Overall 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 25-30 weeks

  4. 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 35 weeks

Timeline

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

  1. First posted21 Dec 2020
  2. Study start20 May 2020
  3. Primary completion30 Jul 2021 (estimated)
  4. Study completion28 Feb 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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04676997
Sponsor's protocol ID
MA-BC-II-006
Status last verified
Dec 2020
First submitted
30 Nov 2020
Last updated
21 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Nab paclitaxel and Epirubicin in people with Triple Negative Breast Cancer, run by Shandong Cancer Hospital and Institute 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 20 inclusion and 24 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 21 Dec 2020. 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 Jinming Yu, MD (+8613806406293, jn7984729@public.jn.sd.cn), 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 27-30 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 NCT04676997.

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 21 Dec 2020.

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