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

NCT04418154 | Active Not Recruiting Phase 2

• 1 other identifier: SCHBCC-N027
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Triple Negative Breast Cancer

Keywords

Programmed Death-1

Outcome Measures

Primary Outcomes (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.

  Immediately after the surgery

Secondary Outcomes (6)

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

  Immediately after the surgery

• Objective response rate (ORR)

  Immediately after the surgery

• Breast conservative surgery rate

  Immediately after the surgery

• Event-free survival (EFS)

  Approximately 3 years

• Adverse events (AEs)

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

Study Arms (1)

EC-ABX/PD-1

EXPERIMENTAL

Patients who are treated with epirubicin hydrochloride andcyclophosphamide followed by nanoparticlealbumin-bound paclitaxel and Toripalimab

Drug: epirubicin hydrochloride; Drug: Cyclophosphamide; Drug: Albumin bound paclitaxel; Drug: Toripalimab

Interventions

epirubicin hydrochloride DRUG

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

EC-ABX/PD-1

Cyclophosphamide DRUG

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

EC-ABX/PD-1

Albumin bound paclitaxel DRUG

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.

EC-ABX/PD-1

Toripalimab DRUG

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

EC-ABX/PD-1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer Center, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

• 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.

  PMID: 39045544 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Epirubicin; Cyclophosphamide; Albumin-Bound Paclitaxel; toripalimab

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Breast Surgery Vice President, Cancer Hospital, Fudan University

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 5, 2020
• Study Start: June 9, 2020
• Primary Completion: September 28, 2022
• Study Completion: December 31, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)