De-escalation of adjuvant chemotherapy in HER2-positive, estrogen receptor-negative, node-negative early breast cancer subjects who achieved pathological complete response after neoadjuvant chemotherapy and dual HER2-blockade

Korean Cancer Study Group0 个研究点目标入组 1,065 人开始时间: 待定最近更新: 2022年9月20日

试验速览

阶段: 未知
状态: 尚未招募
发起方: Korean Cancer Study Group
入组人数: 1,065

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional Study

入排标准

年龄范围: 18(Year) 至 o Limit（—）
性别: All

入选标准

•1) Male or Female.
•2) Age =18 years old.
•3) Eastern Cooperative Oncology Group (ECOG) performance status =1. (Appendix Table 1).
•4) Subjects whose tumors measure =15 mm and = 50 mm, according to clinical staging performed with imaging exams (either mammography, ultrasound or breast magnetic resonance imaging [MRI]).
•5) Must have histologically confirmed diagnosis of HER2-positive, ER-negative, and progesterone receptor (PR)-negative breast cancer:
•HER2-positive defined as a score of 3+ by IHC or a positive ISH (ratio of HER2 copy number/chromosome 17 =2 or average HER2 copy number =6 signals per cell).
•ER and PR-negative defined as nuclear staining <1% by IHC.
•6) Subjects with multifocal or multicentric invasive disease are eligible as long as all the lesions can be characterised and are confirmed to be HER2-positive
•7) Node-negative disease: no axillary lymph nodes identifiable at ultrasound, or in case of suspect axillary lymph nodes are identified, fine-needle aspiration or core biopsy must be carried out to confirm that axillary status is negative. A de-identified copy of the ultrasound report and potential biopsy results must be provided.
•8) Serum pregnancy test (for women of childbearing potential) negative within 7 days prior to treatment start.
•9) Women of childbearing potential must agree to use 1 highly effective contraceptive method (see protocol section 6.15.1) from the signing of the ICF until at least 7 months after last dose of study drug (and until at least 12 months if Confidential women receive cyclophosphamide); or they must totally abstain from any form of sexual intercourse. Men with a partner of childbearing potential must agree to use condom during the course of this study and for at least 7 months after the last administration of study treatment.
•10) Adequate bone marrow and coagulation functions as defined below:
•Absolute neutrophil count =1500 /µL or 1.5x109/L
•Hemoglobin =9 g/dL (blood transfusions to reach these levels of haemoglobin are allowed)
•Platelets =100,000/µL or 100x109/L
•International normalized ratio (INR) and activated partial thromboplastin time (aPTT) = 1.5 ×ULN
•11) Adequate liver function as defined below:
•Serum total bilirubin =1.5 x ULN. In case of known Gilbert’s syndrome =3xUNL is allowed
•AST (SGOT)/ALT (SGPT) =2.5 x ULN
•Alkaline phosphatase =2.5 x ULN
•12) Adequate renal function as defined below:
•Creatinine =1.5 x UNL or creatinine clearance >60 mL/min/1.73 m2
•13) Completion of all necessary screening procedures within 28 days prior to enrolment.
•14) Adequate cardiac function, defined as a left ventricular ejection fraction =55% estimated by echocardiogram (ECHO) or multiple-gated acquisition scintigraphy (MUGA).
•15) Availability of a pre-treatment tumor biopsy sample as specified bellow:
•One FFPE tumor block (preferred)
•If a block cannot be provided, 25 unstained FFPE slides of 4 µm thickness from the pre-treatment tumor biopsy must be provided
•In either case, the local pathologist should ensure that a H&E-stained slide has a tumor surface of at least 4mm2 and that the tumor cellularity is =10%
•16) Signed Informed Consent form (ICF) obtained prior to any study related procedure.
•17) Subject is willing and able to comply with the protocol for the duration of the study including treatment, scheduled visits and assessments.
•Inclusion criterion applicable to FRANCE only:
•18) Subject is affiliated to the French Social Security System

排除标准

•1) Pregnant and/or lactating women.
•2) Subjects who present node-positive disease (N1), confirmed at imaging and/or biopsy.
•3) Bilateral invasive breast cancer
•4) Evidence of metastatic breast cancer: all subjects must have had a CT/MRI scan of the thorax/abdomen/pelvis to rule out metastatic breast cancer prior to enrolment. A screening bone scan must have been done if ALP and/or corrected calcium levels were above the institutional upper limits at screening (if PET/CT was used as an alternative imaging exam, a bone scan and/or CT/MRI is not required).
•5) Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator’s opinion, may interfere with completion of the study.
•6) Previous exposure to any anti-HER2 treatment.
•7) Concomitant exposure to any investigational products as part of a clinical trial within 30 days prior to enrolment.
•8) Subject with second primary malignancies diagnosed = 5 years before enrolment in the study. Exceptions are: adequately treated non-melanoma skin cancer, in situ cancer of the cervix, ductal carcinoma in situ of the breast, and any other solid or haematological tumors diagnosed > 5 years before enrolment and for which no chemotherapy and no systemic treatment were necessary (meaning that no previous exposure to chemotherapy is allowed), with no evidence of disease recurrence.
•9) Resting electrocardiogram (ECG) with QTc >470 msec detected at 2 or more time points within a 24-hour period, or family history of long QT syndrome.
•10) Left ventricular ejection fraction <55% estimated by ECHO or MUGA. Peripheral neuropathy (CTCAE version 5) grade =2.
•11) Major surgery within 2 weeks prior to enrolment.
•12) Subject with HIV, Hepatitis B or Hepatitis C infection documented by serology, except for those subjects with a previous exposure to Hepatitis B who developed an effective immune response (HBSAg-negative and anti-HBS-positive).
•13) Previous allogeneic bone marrow transplant.
•14) Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE grade =3).
•15) Subjects who received live attenuated vaccines within 2 weeks before enrolment.
•Exclusion criterion applicable to FRANCE only
•17) Vulnerable persons according to the article L.1121-6 of the CSP, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the CSP.

研究者

发起方

Korean Cancer Study Group

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