Phase Ib/II Clinical Trial to Evaluate the efficacy and safety of Neo-adjuvant chemotherapy with Autologous Cytokine-Induced Killer Cells Therapy in patients with estrogen receptor negative/HER-2 negative breast cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0008408
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 51
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
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 <1 cm in size
7 Ejection fraction <55% on multi-gated acquisition scan (MUGA) scan/echocardiography (echoCG)
8 Clinically significant gastrointestinal malabsorption
- including, but not limited to:
8.1 Active peptic ulcer
8.2 Inflammatory bowel disease
8.3 Other gastrointestinal diseases at risk of perforation, history of gastrointestinal perforation, fistula or intraperitoneal abscess
9 Difficulty in administering anthracyclines due to arrhythmia or valvular heart disease as determined by the investigator
10 Clinically significant gastrointestinal malabsorption
- including, but not limited to:
10.1 Malabsorption syndrome
10.2 Major resection of the stomach or small bowel
11 Corrected QT interval >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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pathologic CR Rate
- Secondary Outcome Measures
Name Time Method Satety(NCI CTCAE version 6.0);Response Rate