None listed
Conditions
Interventions
Drug : 1. The study will consist of Step 1 and Step 2 (Stage I - Stage II).
2. The safety of the combination therapy will be evaluated by the safety assessment for Step 1. Whether to further proceed t
additional CT may be performed) maybe repeated every 2 cycles, but it is not mandatory, except for tumor imaging at Cycle4 and Cycle 8 prior to the surgery. (Tumor imaging [MRI] following Cycle 4 and
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 A planned neoadjuvant therapy with AC and docetaxel in patients with histologically confirmed locally advanced breast cancer 2 Age ≥19 to ≤70 years 3 cT2N0 or cT1-3/N+ M0 (ER/PR negative [Allred score <3], c-erbB2 0, 1+ or 2+ [SISH negative]) 4 Available biopsy sample (FFPE) at diagnosis. If tested at other hospitals, a slide for ER, PR, HER2, KI67 immunohistochemistry reading and 15 additional unstained slides are required. 5 HER2-negative breast cancer 6 At least 1 measurable lesion as per RECIST 1.1 on the image 7 Women of childbearing potential who agreed to use adequate contraception during the study (from the start to few hours or days after the last administration considering the half-life) 8 ECOG performance status of 0-2 9 Adequate organ function (Appendix A) 10 Voluntarily signed the written consent form to participate in the study
Exclusion criteria
Exclusion criteria: 1 Inflammatory breast cancer 2 Bilateral breast cancer 3 Clinical T4Nx 4 Stroke including transient ischemic attack 5 Untreated pulmonary thrombosis or deep vein thrombosis within 6 months: Patients are eligible if they had no symptoms after at least 6 weeks of therapeutic anticoagulant therapy within 6 months 6 Prior history of malignant tumor, with the exception of following: 6.1 Malignant tumor of a different type, with DFS of 3 years 6.2 Complete resection of skin tumor, except for melanoma 6.3 Curatively resected early gastric cancer 6.4 Differentiated thyroid cancer of 480 msec in electrocardiogram (ECG) 12 Following cardiovascular abnormalities in the last 6 months: 12.1 Coronary angioplasty or stenting 12.2 Acute myocardial infarction 12.3 Unstable angina 12.4 Coronary bypass grafting 12.5 Symptomatic peripheral artery diseases 13 Congestive heart failure of New York Heart Association (NYHA) class III or IV(Appendix B) 14 Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) 15 Major surgery or trauma within 28 days prior to the first study treatment and/or unhealed wound, fracture, ulcer: maneuver such as catheter placement is not included in the major surgery 16 Acute bleeding or bleeding tendency 17 Lesion in the airway or risk of pulmonary hemorrhage due to a lesion involving major pulmonary blood vessels (Patients with a tumor in contact with blood vessels but not invading them are eligible) 18 Protruding lesion in the main bronchus or lobar bronchi. Patients with a lesion in the segmental bronchus are eligible 19 Recent history of hemoptysis (within 8 weeks prior to the first study treatment, ½ teaspoons) 20 Administration of other non-tumor study treatment within 30 days prior to the first dose or 5 half-lives of the drug 21 Pregnant or breast-feeding women 22 A history of or current autoimmune diseases 23 Ineligibility or inability to participate in the study at the judgement of the investigator
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Satety(NCI CTCAE version 6.0);Response Rate | — |
Primary
| Measure | Time frame |
|---|---|
| pathologic CR Rate | — |
Countries
Korea, Republic of
Contacts
Public ContactJeong A Park
National Cancer Center
Outcome results
None listed