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Clinical Trials List

Protocol NumberWO39391
NCT Number(ClinicalTrials.gov Identfier)NCT03498716

2018-08-31 - 2026-05-31

Phase III

Not yet recruiting3

Recruiting1

Terminated9

ICD-10C50.919

Malignant neoplasm of unspecified site of unspecified female breast

ICD-9174.9

Malignant neoplasm of female breast, unspecified

A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY COMPARING ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH ADJUVANT ANTHRACYCLINE/TAXANE-BASED CHEMOTHERAPY VERSUS CHEMOTHERAPY ALONE IN PATIENTS WITH OPERABLE TRIPLE-NEGATIVE BREAST CANCER

  • Trial Applicant

    Pharmaceutical Research Associates Taiwan Inc.

  • Sponsor

    F. Hoffmann-La Roche Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chiun-Sheng Huang Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator 賴鴻文 Division of General Surgery
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chang-Fang Chiu Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

2 Not yet recruiting

Audit

None

Principal Investigator Shin-Cheh Chen Division of General Surgery
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wei-Pang Chung Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 俞志誠 Division of General Surgery
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ming-Feng Hou Division of General Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 張源清 Division of General Surgery
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 黃文聰 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 饒坤銘 Division of General Surgery
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Tsu-Yi Chao 無
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 鍾奇峰 無
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Triple-Negative Breast Cancer

Objectives

Primary Efficacy Objective: ●To evaluate the efficacy of adjuvant atezolizumab + T-AC/EC compared with T AC/EC alone in patients with TNBC Secondary Efficacy Objectives: ●To evaluate the efficacy of adjuvant atezolizumab + T-AC/EC compared with T AC/EC alone ●To evaluate PROs of function and HRQoL associated with atezolizumab + T-AC/EC compared with T AC/EC alone, as measured by the functional and HRQoL scales of the EORTC QLQ-C30

Test Drug

Atezolizumab (RO5541267)

Active Ingredient

Atezolizumab (RO5541267)

Dosage Form

Injection

Dosage

1200

Endpoints

iDFS, defined as the time from randomization until the date of the first occurrence of one of the following events:
- Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion)
- Ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast)
- Ipsilateral second primary invasive breast cancer
- Contralateral invasive breast cancer
- Distant recurrence (i.e., evidence of breast cancer in any anatomic site [other than the sites mentioned above]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer
- Death attributable to any cause, including breast cancer,non-breast cancer, or unknown cause

Inclution Criteria

Patients must meet the following criteria for study entry:
• Signed Informed Consent Form (ICF)
• Ability to comply with protocol, in the investigator’s judgment
• Women or men aged ≥ 18 years at time of signing ICF
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Non-metastatic operable Stage II−III breast cancer
• Histologically documented TNBC (negative HER2, ER, and PgR status)
• Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
• Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing
mastectomy.
• Pathological tumor-node-metastasis staging (Union for International Cancer Control/American Joint Committee on Cancer
[UICC/AJCC], 8th edition): Patient must have had sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection for
evaluation of pathologic nodal status.
• Patients with synchronous bilateral invasive disease are eligible only if all bilateral invasive lesions are histologically confirmed
as triple negative by central lab and have completed adequate pathological tumor-node metastasis staging bilaterally as
described above.
• No more than 8 weeks (56 days) may elapse between definitive breast surgery (or the last surgery with curative intent if
additional resection is required for breast cancer) and randomization.
• Baseline LVEF ≥ 53% measured by ECHO (preferred) or MUGA scans Baseline LVEF to be conducted within 28 days prior to
initiation of study treatment.
• Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 28 days prior to the first study treatment
• Negative HIV test at screening
• Negative hepatitis B surface antigen (HBsAg) test at screening
• Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B
virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total
HBcAb test.
• Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at
screening
• The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
• Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred)
or at least 25 unstained slides, with an associated pathology report documenting locally assessed ER, PgR, and HER2 negativity.
Patients with 20 to 25 unstained slides available at baseline may be eligible upon discussion with the Medical Monitor.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, or 6 months after the last dose of paclitaxel or doxorubicin, or 12 months after the last dose of cyclophosphamide, whichever is later.
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
• Women who are not postmenopausal (≥ 12 months of non−therapy-induced amenorrhea) or have not undergone a sterilization procedure must have a negative serum pregnancy test result within 14 days prior to initiation of study drug.
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the completion of PRO questionnaires.

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from study entry:
• Prior history of invasive breast cancer
• Any T4 clinical tumor as defined by tumor-node metastasis classification in UICC/AJCC,8th edition, including inflammatory breast cancer
• For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment
• Previous therapy with anthracyclines or taxanes for any malignancy
• History of DCIS and/or LCIS that was treated with any form of systemic, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developedPatients who had their DCIS/LCIS treated only with surgery and/or contralateral DCIS
treated with RT are allowed to enter the study.
• Contraindication to RT when adjuvant RT is clinically indicated
• Cardiopulmonary dysfunction as defined by any of the following prior to randomization:History of NCI CTCAE v4.0 Grade ≥ 3 symptomatic congestive heart failure or NewYork Heart Association (NYHA) criteria Class ≥ II Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate > 100/min at
rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade atrioventricular [AV]-block [second degree AV-block Type 2 Mobitz 2, or third-degreeAV-block])Significant symptoms (Grade ≥ 2) relating to left ventricular dysfunction, cardiac
arrhythmia, or cardiac ischemiaMyocardial infarction within 12 months prior to randomization Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) Evidence of transmural infarction on ECG
Requirement for oxygen therapy
• Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells
• Known allergy or hypersensitivity to any component of the atezolizumab formulation
• Known allergy or hypersensitivity to any component of the paclitaxel (e.g., polyoxyl 35 castor oil), cyclophosphamide, or doxorubicin/epirubicin formulations
• Known allergy or hypersensitivity to filgrastim or pegfilgrastim or GM-CSF formulations
• Active or history of autoimmune disease or immune deficiency, including, but not limited to,myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus,rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, or multiple sclerosis with the
following exceptions:Patients with a history of autoimmune-related hypothyroidism on a stable dose of
thyroid replacement hormone are eligible for this study.Patients with controlled Type I diabetes mellitus who are on an insulin regimen may be eligible for this study.
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans),drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Current treatment with anti-viral therapy for HBV
• Urinary outflow obstruction
• Active tuberculosis
• 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
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
• Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment
• Prior allogeneic stem cell or solid organ transplant
• Administration of a live attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study or within 5 months after the last dose of atezolizumab
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment
complications
• Prior treatment with CD137 agonists or immune checkpoint−blockade therapies, including anti-CD40, anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies
• Treatment with systemic immunostimulatory agents (including, but not limited to, interferons,interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment
• Treatment with systemic immunosuppressive medications (including, but not limited to,prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis factor [anti-TNF] alpha agents) within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study
Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the Medical Monitor. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed.
• Pregnant or lactating, or intending to become pregnant during the study
•Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, and inherited liver disease

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    2300 participants

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