None listed
Conditions
Interventions
Drug : (A, Neoadjuvant setting): Day1 X 6 cycles q3weeks
- Docetaxel (75mg/m2, Intravenous)
- Atezolizumab (1200mg, Intravenous)
- Trastuzumab (600mg, Subcutaneous)
- Pertuzumab (840mg loading dose
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Invasive breast cancer confirmed as local advanced, inflammatory, or histologically early breast cancer. 2) Primary breast tumor site of > 2cm or right axillary lymph node metastasis confirmed by fine needle aspiration(FNA) (American Joint Committee on Acncer(AJCC) 7th edition, clinical stage IIA-IIIC) 3) Eastern Cooperative Oncology Group(ECOG) performance status 0-1 4) patient has Human epidermal growth factor receptor type 2(HER2)-positive breast cancer (as 3+ by Immunohistochemistry (IHC) or if 2+ positive is found in Human epidermal growth factor receptor type 2(HER2)-Silver in situ hybridization(SISH) (or Flurescence in situ hybridization(FISH), Chromogenic in situ hybridization(CISH)) test) 5) Available biopsy tissue of a primary tumor 6) Left ventricular ejection fraction(LVEF) =55% at baseline (Echocardiogram or Multigated Acquisition(MUGA) scan) 7) Patient is an adult, female = 18 years old at the time of informed consent 8) Women of child bearing potential must have a negative urine or serum pregnancy test result 9) Adequate bone marrow function (= Absolute neutrophil conunt(ANC) 1,500/ul, = platelet 100,000/ul, = hemoglobin 9.0 g/dl) 10) Adequate kidney function (= serum creatinine 1.5 mg/dl or Creatinine Clearance(CCr) = 50 ml/min) 11) Adequate liver function ( = serum bilirubin 2.5 mg/dl, = Aspartae transaminase(AST) / Alanine aminotransferase(ALT) X upper limit of normal (ULN)) 12) Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods 13) Agree to informed consent and willing and able to comply with the protocol 14) Consent to tissue and blood sample for biomarker
Exclusion criteria
Exclusion criteria: 1) Metastatic breast cancer (Stage IV) 2) Tumor size less than 2cm or and N0 3) Previous or concomitant malignancy of any other type that could affect compliance with the protocol or interpretation of results. (Except for in situ carcinoma of the cervix or adequately treated non-melanoma skin carcinoma, thyroid papillary cancer or a malignant tumor that did not recur for 5 years.) 4) Any previous treatment against including chemotherapy, hormonal therapy 5) Administration of a live, attenuated vaccine within 4 weeks before Day 1 or anticipation that such a live attenuated vaccine will be required during the study 6) Severe infections within 4 weeks prior to Day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Signs or symptoms of significant infection within 2 weeks prior to Day 1 7) Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1 8) Active tuberculosis or evidence of active pneumonitis 9) History of idiopathic pulmonary fibrosis 10) History of clinically significant liver disease, current alcohol abuse, Known active infections for hepatitis B virus or hepatitis C virus A. Patients with past or resolved hepatitis B infection (defined as having a negative HBsAg test and a positive hepatitis B core antigen [anti-HBc] test) are eligible. B. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction assay (PCR) is negative for HCV RNA C. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease. 11) Uncontrolled hypertension (systolic >150 and/or diastolic >100), unstable angina, congestive heart failure (total New York Heart Association(NYHA) grades), serious cardiac arrhythmia requiring treatment (except for atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months prior to enrollment or Left ventricular ejection fraction(LVEF) 1.5 X upper normal limit (except for Gilbert’s syndrome), Aspartae transaminase(AST) / Alanine aminotransferase(ALT) > 1.5 X upper normal limit, Alkaline phosphatase(ALP) > 2.5 X upper normal limit 13) Immunosuppression or positive human immunodeficiency virus(HIV) test 14) Requirement for oxygen therapy, dyspnea at rest, or other disease 15) Uncontrolled serious infection 16) Uncontrolled serious medical and psychological disease (including active heart disease) 17) Patients with prior allogeneic stem cell or solid organ transplantation 18) Pregnant or lactating or intending to become pregnant during or within 7 months after the last dose of study treatment 19) Known allergy or hypersensitivity to the components of the Investigational product 20) History of autoimmune disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis 21) Patients who are not available tumor tissue 22) In the investigator’s judgment, patient is unable or unwilling to comply with the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response(pCR) rate of neoadjuvant chemotheraphy | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year Event free survival (EFS) of the patients with pCR vs. non-pCR to neoadjuvant chemotheraphy;Overall survival (OS);Disease Free Survival (DFS);Quality of Life (QoL);Safety and Toxicity;Biomark | — |
Countries
Korea, Republic of
Contacts
Public Contacthyunjung shin
Samsung Medical Center
Outcome results
None listed