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Triple Negative Breast CancerPhase 2NeoTENNISNCT04418154

Neoadjuvant Dose-dense EC Followed by ABX With PD-1 for Triple Negative Breast Cancer Patients

A Phase 2 study testing epirubicin hydrochloride, Cyclophosphamide and Albumin bound paclitaxel 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is to evaluate the efficacy and safety for dose-dense epirubicin hydrochloride with cyclophosphamide followed by nanoparticlealbumin-bound paclitaxel with PD-1 in neoadjuvant therapy for patients with triple-negative breast cancer, and to explore the predictive value of biological markers for the treatment. 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?
epirubicin hydrochloride, Cyclophosphamide and Albumin bound paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
9 Jun 2020to 31 Dec 2025
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

  • Age 18 to 70 years old, female.
  • Patients with histologically confirmed unilateral primary invasive breast cancer who meet the criteria of cT2-4NanyM0.
  • Patients with ER negative and PR negative by immunohistochemistry (IHC), and HER-2 negative disease. HER2-negative disease was defined as follows: disease whose HER-2 is 1+ or negative by IHC, or fluorescence in situ hybridization (FISH) is negative if IHC is 2+.
  • According to the RECIST 1.1 criteria, there is at least one measurable objective lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance score 0-1.
  • Baseline left ventricular ejection fraction (LVEF) is greater than or equal to (>/=) 55%.
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  • Bone marrow function is required as follows: neutrophils are more than or equal to (>/=) 1.5×109/L, platelets more than or equal to (>/=) 100×109/L, and hemoglobin more than or equal to (>/=) 90g/L.
  • Hepatic and renal function are required as follows: serum creatinine is less than or equal to (</=) 1.5 times of upper limits of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) less than or equal to (</=) 2.5 times of ULN, and total bilirubin less than or equal to (</=) 1.5 times of ULN or </= 2.5 times of ULN if patient is with Gilbert's syndrome.
  • With good compliance with the planned treatment, are able to understand the follow-up procedures of this study and sigh the informed consent form.
  • Signed informed consent.

Who cannot join

  • Received radiotherapy, chemotherapy, surgery or other targeted and immunotherapy for triple-negative breast cancer before enrollment.
  • With heart disease classified as New York Heart Association class (NYHA) grade II or above (including grade II) are identified by the investigator.
  • With severe systemic infection or those with other serious illnesses.
  • Known to be allergic or intolerant to chemotherapy drugs or their excipients.
  • With a history of autoimmune diseases or those using glucocorticoids or immunosuppressive drugs.
  • With known active stage of HBV or HCV infection or hepatitis B DNA ≥500, or patients with chronic abnormal liver function.
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  • With a history of abnormal thyroid function.
  • With grade ≥ 2 peripheral neuropathy.
  • With a clear history of neurological or mental disorders, including epilepsy or dement.
  • Previous non-breast malignancy within 5 years prior to study entry excluding healed cervical carcinoma in situ and non-melanoma skin cancer.
  • History of other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ and non-melanoma skin cancer.
  • Pregnancy or lactation, and patients of childbearing potential who refuse to use adequate contraception during the course of this study.
  • Prior participation in other studies within 30 days prior to the administration of the first dose of the investigational drug.
  • Patients who are deemed to be unsuitable for this study by investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Cancer Center, Fudan University

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Official title: Neoadjuvant Anthracycline Followed by Toripalimab Combined With Nab-paclitaxel in Patients With Early Triple-negative Breast Cancer

This study is to evaluate the efficacy and safety for dose-dense epirubicin hydrochloride with cyclophosphamide followed by nanoparticlealbumin-bound paclitaxel with PD-1 in neoadjuvant therapy for patients with triple-negative breast cancer, and to explore the predictive value of biological markers for the treatment.

Read the detailed description

This study is an open single arm study, which would undergo optimal two stage designs. 60 patients who are diagnosed with triple-negative breast cancer would have dose-dense epirubicin hydrochloride with cyclophosphamide followed by nanoparticlealbumin-bound paclitaxel with PD-1 regimen for neoadjuvant therapy if they meet the eligibility criteria. The regimen is as follows: epirubicin hydrochloride (90mg/m2, d1) plus cyclophosphamide (600mg/m2, d1) every 14 days as one cycle for 4 cycles, followed by nanoparticlealbumin-bound paclitaxel (125mg/m2, d1) per week for 3 weeks as one cycle for 4 cycles, and Toripalimab (240mg, d1) every 3 weeks as one cycle for 4 cycles. pathological complete response would be the primary endpoint. The change of biological markers and safety of the regimen would also be evaluated.

Being tested
epirubicin hydrochloride, Cyclophosphamide, Albumin bound paclitaxel, Toripalimab
Keywords
Programmed Death-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.

  • epirubicin hydrochlorideDrug

    Take epirubicin hydrochloride (90mg/m2, d1) every 14 days as one cycle for 4 cycles with cyclophosphamide, followed by nanoparticlealbumin-bound paclitaxel and Toripalimab.

  • CyclophosphamideDrug

    Take cyclophosphamide (600mg/m2, d1) every 14 days as one cycle for 4 cycles with epirubicin hydrochloride, followed by nanoparticlealbumin-bound paclitaxel and Toripalimab.

  • Albumin bound paclitaxelDrug

    Take nanoparticlealbumin-bound paclitaxel (125mg/m2, d1) per week for 3 weeks as one cycle for 4 cycles with Toripalimab, following epirubicin hydrochloride and cyclophosphamide.

  • ToripalimabDrug

    Take Toripalimab (240mg, d1) every 3 weeks as one cycle for 4 cycles with nanoparticlealbumin-bound paclitaxel, following epirubicin hydrochloride and cyclophosphamide.

Study groups in NCT04418154
Study groupRoleWhat they receive
EC-ABX/PD-1ExperimentalPatients who are treated with epirubicin hydrochloride andcyclophosphamide followed by nanoparticlealbumin-bound paclitaxel and Toripalimab
Receives: Drug: epirubicin hydrochloride; Drug: Cyclophosphamide; Drug: Albumin bound paclitaxel; Drug: Toripalimab

What is being measured

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

  1. Total Pathologic complete response (tpCR)

    Defined as no residual invasive cancer cells are found in the pathological examination of breast and axillary lymph node; if only residual in situ cancer cells are present in the surgical specimens, it can also be considered as achieving a pathological complete response.

    Measured: Immediately after the surgery

Secondary outcomes (6)

  1. Breast pathologic complete response (bpCR: ypT0/is) rate

    Defined as the absence of invasive cancer cells in breast.

    Measured: Immediately after the surgery

  2. Objective response rate (ORR)

    Defined as the proportion of patients with a complete or partial response by MRI.

    Measured: Immediately after the surgery

  3. Breast conservative surgery rate

    Defined as the percentage of patients who undergo breast-conserving surgery after neoadjuvant therapy, out of the total number of evaluable cases.

    Measured: Immediately after the surgery

  4. Event-free survival (EFS)

    Defined as the time from the date of the first study dose 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: Approximately 3 years

  5. Adverse events (AEs)

    Refer to any untoward medical occurrence in a study subject administered an investigational product which does not necessarily have a causal relationship with the treatment. AE is assessed according to the NCI-CTCAE 5.0.

    Measured: During this period between the start of randomization and the last visit, approximately 3 years

  6. Change in immune-related tissue biomarkers

    The proportion of Tumor-infiltrating lymphocytes (TILs) is evaluated through HE staining. Immunohistochemical staining of PD-1, PD-L1, AR, CD8, and FOXC1) is performed. TILs, PD1, PD-L1, AR, CD8, and FOXC1 in tumor samples by biopsy at baseline, at the end of Cycle 2 and by surgery immediately after surgery would be evaluated by HE or immune staining.

    Measured: At baseline, at the end of first 2 cycles (each cycle is 14 days) and immediately after the surgery

Timeline

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

  1. First posted5 Jun 2020
  2. Study start9 Jun 2020
  3. Primary completion28 Sep 2022
  4. Study completion31 Dec 2025 (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
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04418154
Sponsor's protocol ID
SCHBCC-N027
Acronym
NeoTENNIS
Status last verified
May 2024
First submitted
25 May 2020
Last updated
21 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • He M, Hao S, Ma L, Xiu B, Yang B, Wang Z, Xue J, Chi Y, Xiong M, Chen J, Huang X, Liu X, Wu S, Xiao Q, Huang Y, Shui R, Cao A, Li J, Di G, Yang W, Hu X, Liu G, Yu K, Jiang Y, Wang Z, Shao Z, Wu J. Neoadjuvant anthracycline followed by toripalimab combined with nab-paclitaxel in patients with early triple-negative breast cancer (NeoTENNIS): a single-arm, phase II study. EClinicalMedicine. 2024 Jun 28;74:102700. doi: 10.1016/j.eclinm.2024.102700. eCollection 2024 Aug.

    PubMed 39045544

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing epirubicin hydrochloride, Cyclophosphamide and Albumin bound paclitaxel 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 10 inclusion and 14 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 May 2024. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Pathologic complete response (tpCR) (time frame: Immediately after the 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 NCT04418154, which also lists 1 linked publication.

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 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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