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Triple Negative Breast CancerPhase 2TEMPLATENCT04913571

Tislelizumab in Combination With Eribulin for Patients With Metastatic Previously heaviLy-treAted TriplE-negative Breast Cancer：A Prospective Multiple-center Phase II Study

A Phase 2 study testing Eribulin and Tislelizumab in people with Triple Negative Breast Cancer, run by Fudan University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Triple-negative breast cancer (TNBC) lacks effective treatment options due to the absence of traditional therapeutic targets.This study is a multicentre, prospective trial. The primary objective of the trial was to evaluate the objective response rate to tslelizumab combined with eribulin in different… 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?
Eribulin and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
265 participants
Where
1 siteChina
Study dates
27 May 2021to 1 Jun 2023
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

  • Participants fulfilling all of the following inclusion criteria are eligible for the study:
  • Female patients aged 18-75 years (including cutoff value).
  • Eastern Cooperative Oncology Group Performance Status of 0-1.
  • Life expectancy ≥ 12 weeks.
  • Histopathologically confirmed recurrent (unresectable) or metastatic triple-negative breast cancer; ER and PR negative is defined as ER <1% positive, PR <1% positive. HER-2 negative is defined as HER-2 (-) or (1+) by immunohistochemistry, HER-2 (2+) must be tested by FISH with negative result, HER-2 (1+), FISH is optional and negative;
  • At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
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  • Previously received more than 2 lines of systemic chemotherapy for metastatic breast cancer.（the adjuvant chemotherapy regimen administered after recurrence within 6 months was considered as the first-line chemotherapy regimen）
  • Adequate organ function, i.e. meeting the following criteria. Hb ≥ 90 g/L (no transfusion within 14 days); ANC ≥ 1.5 × 109 /L; PLT ≥ 75 × 109 /L.
  • Liver function: total bilirubin TBIL ≤ 1.5×ULN (upper limit of normal); ALT and AST ≤ 3×ULN.
  • serum Cr ≤ 1.5×ULN. Left ventricular ejection fraction (LVEF) ≥ 50% QTcF(Fridericia correction) ≤ 470 ms
  • Subjects voluntarily joined the study, signed informed consent.

Who cannot join

  • All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation
  • Patients who have undergone systemic, radical brain or meningeal metastasis (radiotherapy or surgery), but have been confirmed to have been stable for at least 4 weeks, and who have stopped systemic hormonal therapy for more than 2 weeks without clinical symptoms can be included. Innovative brain metastasis patients, the number of transition stoves is ≤1, and the maximum path <1 cm;
  • Anticancer therapy related toxicities have not resolved or downgraded to Grade 1 or less;
  • Previously received any Eribulin and /or anti PD-1，anti PD-L1， CTL-4 treatment.
  • Participants with active or a history of autoimmune diseases that probably will recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, etc.), or with high risk (e.g. organ transplantation requiring immunosuppressive therapy). However, participants with the following diseases are eligible: skin diseases requiring no systemic treatment (such as eczema, skin rash covering less than 10% of the body surface, psoriasis without ophthalmic symptoms, etc.).
  • Need to receive systemic corticosteroids (dose equivalent to > 10 mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment or during the study period. Those under the following conditions are eligible: a) Locally external use or inhaled corticosteroids; b) short-term ( 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases.
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  • Suffered from idiopathic lung disease, interstitial lung disease, pulmonary fibrosis, acute lung disease, etc., except for local interstitial pneumonia induced by radiotherapy;
  • There are ascites, pleural effusion, pericardial effusion with clinical symptoms at baseline, those who need drainage, or those who have undergone drainage of serous effusion within 4 weeks before the first dose.
  • Received systemic therapy such as chemotherapy, molecular targeted therapy or other clinical trial drugs within 4 weeks before enrollment; other than observational clinical study
  • Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as carcinoma in situ of the cervix or Non-Melanocytic Tumors of the Skin;
  • Has any serious and/or uncontrolled disease.
  • Have a history of allergies to the drug components of this regimen.
  • Patients with active HBV and HCV infection; stable hepatitis B after drug treatment (HBV virus copy number is higher than the upper limit of reference value) and cured hepatitis C patients (HCV virus copy number exceeds the lower limit of detection method) can be included.
  • History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation.
  • Pregnant or lactating women.
  • Childbearing female who refuse to accept any contraception practice during the treatment period.
  • The investigator determined who was not suitable for the study.

Trial locations and contacts

1 site in 1 country.

Jian Zhang, MD,PhD contact

+8664175590 ext. 85000

syner2000@163.com

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Jian Zhang, MD,PhD, +8664175590 ext. 85000, syner2000@163.com

Other trials in China

About this study

Triple-negative breast cancer (TNBC) lacks effective treatment options due to the absence of traditional therapeutic targets.This study is a multicentre, prospective trial. The primary objective of the trial was to evaluate the objective response rate to tslelizumab combined with eribulin in different subgroups（subgroup A: TMB High, B: PD-L1 positive，C, immunomodulatory (IM)，D，NanoString superiority，E，other types）of relapse or metastasis TNBC after failure of second-line chemotherapy. Therefore, exploring new therapeutic options and identifying subgroups of patients who may benefit from special treatments has been a focal point of research. Doing so, we expect to guide new investigation efforts in this area.

Being tested
Eribulin, Tislelizumab
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 NCT04913571
Study groupRoleWhat they receive
TMB High groupExperimentalNot described
Receives: Drug: Eribulin; Drug: Tislelizumab
PD-L1 positive groupExperimentalNot described
Receives: Drug: Eribulin; Drug: Tislelizumab
Immunomodulatory (IM) groupExperimentalNot described
Receives: Drug: Eribulin; Drug: Tislelizumab
NanoString superiority groupExperimentalNot described
Receives: Drug: Eribulin; Drug: Tislelizumab
other typesExperimentalNot described
Receives: Drug: Eribulin; Drug: Tislelizumab

What is being measured

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

  1. Overall Response Rate (ORR)

    ORR is the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 12 weeks

Secondary outcomes (2)

  1. Overall Survival (OS)

    Time from date of randomization to the date of death from any cause

    Measured: Up to approximately 30 months

  2. Progression-Free Survival (PFS)

    PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

    Measured: Up to approximately 30 months

Timeline

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

  1. First posted4 Jun 2021
  2. Study start27 May 2021 (estimated)
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion1 Jun 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
265 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04913571
Sponsor's protocol ID
TEMPLATE
Acronym
TEMPLATE
Status last verified
May 2021
First submitted
29 May 2021
Last updated
4 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eribulin and Tislelizumab in people with Triple Negative Breast Cancer, run by Fudan University 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 11 inclusion and 17 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 4 Jun 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 Jian Zhang, MD,PhD (+8664175590 ext. 85000, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to approximately 12 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 NCT04913571.

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 4 Jun 2021.

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