A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP, ACTIVE-CONTROLLED STUDY TO COMPARE THE EFFICACY AND SAFETY OF CT-P6 AND HERCEPTIN AS NEOADJUVANT AND ADJUVANT TREATMENT IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER.

CELLTRION, INC.,0 sites6 target enrollmentDecember 24, 2014

Conditions-C50 Malignant neoplasm of breast Malignant neoplasm of breast C50

Overview

Phase: 未知
Intervention: Not specified
Conditions: -C50 Malignant neoplasm of breast
Sponsor: CELLTRION, INC.,
Enrollment: 6
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 24, 2014

End Date

September 3, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

CELLTRION, INC.,

Eligibility Criteria

Inclusion Criteria

•1\.Patient is a female 18 years of age or older.
•2\.Patient who has Eastern Cooperative Oncology Group performance status score of 0 or 1\.
•3\.Patient who has histologically confirmed and newly diagnosed breast cancer.
•4\.Patient who has clinical stage I, II, or IIIa operable breast cancer according to the AJCC Breast Cancer Staging 7th edition.
•5\.At least one measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST)
•a.Tumor lesions: ≥ 10 mm in long axis by computerized tomography scan
•b.Malignant lymph nodes: ≥15 mm in short axis when assessed by computerized tomography scan
•6\.Patient who has human epidermal growth factor receptor (HER) 2 positive status confirmed locally, defined as 3 \+ score by immunohistochemistry (IHC). When the IHC result is equivocal (defined as 2 \+ score), patient who has a positive fluorescence in situ hybridization (FISH) or a chromogenic in situ hybridization (CISH) result.
•7\.Patient who has a normal left ventricular ejection fraction (LVEF) (≥55%) at Baseline, as determined by either two\-dimensional echocardiogram (ECHO) or multiple\-gated acquisition (MUGA) scan. If the patient is randomized, the same method of LVEF assessment, ECHO or MUGA, must be used throughout the study.
•8\.Patient who has known estrogen receptor and progesterone receptor status tested at Screening.

Exclusion Criteria

•1\.Patient who has bilateral breast cancer.
•2\.Patient who is pregnant or lactating.
•3\.Patient who has received prior treatment for breast cancer, including chemotherapy, biologic therapy, hormone therapy, immunotherapy, radiation, or surgery, with the exception of diagnostic biopsy for primary breast cancer.
•4\.Patient who has received any prior therapy with anthracyclines.
•5\.Patient who has other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
•6\.Serious cardiac illness or medical conditions that could preclude the use of trastuzumab, specifically: New York Heart Association (NYHA) class ≥2, history of documented congestive heart failure (CHF), high\-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension.
•7\.Patient who has a current history of infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus, or who has a positive result to the screening test for those infections.
•8\.Patient who has had any recent infection requiring a course of systemic anti\-infectives that were completed ≤14 days before randomization (with the exception of uncomplicated urinary tract infection).
•9\.Patient who is a woman of childbearing potential who is not consenting to use highly effective methods of birth control (e.g., intra\-uterine device, barrier methods including condom and diaphragm, also in conjunction with spermicidal jelly, or total abstinence; Oral, injectable, or implant hormonal contraceptives are not acceptable) during treatment and for an additional 6 months after the last administration of the protocol specified treatment.
•10\.Patient who is currently receiving treatment with another investigational device or medical product; or less than 30 days or 5 half\-lives, whichever is longer, have spanned since ending treatment with another investigational device or medical product.