Docetaxel plus Atezolizumab plus Herceptin SC and Pertuzumab for Patients with Early Breast Cancer and Atezolizumab plus Herceptin SC and Pertuzumab chemotherapy after Surgery

Not Applicable

Active, not recruiting

• Conditions: Neoplasms

• Registration Number: KCT0003774
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 August 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 67

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

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) < 55%
12) Total bilirubin >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.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic complete response(pCR) rate of neoadjuvant chemotheraphy

Secondary Outcome Measures

Name	Time	Method
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