A Phase III, Randomized study of Bevacizumab and Paclitaxel in combination with Atezolizumab as a treatment for patients with locally advanced unresectable or metastatic hormone receptor-positive HER2 negative breast cancer - JCOG1919E

Yonemori Kan0 sites280 target enrollmentJanuary 29, 2021

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Yonemori Kan
Enrollment: 280
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 29, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Yonemori Kan

Eligibility Criteria

Inclusion Criteria

•1\) Histologically diagnosed as breast cancer (invasive cancer).
•2\) Histologically diagnosed as hormone receptor positive (at least one of ER and PgR is positive) and HER2 negative. However, if there are multiple specimens, the histological results of the most recent specimen that meets the eligibility criteria 1\) and 2\) should be used.
•3\) Diagnosed with advanced recurrent breast cancer (either unresectable locally advanced breast cancer, recurrent breast cancer, or Stage IV breast cancer).
•4\) Age 20 years or older on the date of registration. Either male or female are acceptable.
•5\) ECOG performance status (PS) of 0\-2\.
•6\) Patients must have measurable lesions.
•7\) Hormone refractory\[\*1] or life\-threatening metastases\[\*2].
•\[\*1] Hormone refractory: Recurrence within 2 years after the start of postoperative endocrine therapy, or progression within 6 months of endocrine therapy for advanced recurrent breast cancer.
•\[\*2]: Life\-threatening metastases: Symptomatic metastases that require symptomatic relief through urgent tumor shrinkage. Examples include multiple liver metastases, lung metastases, carcinomatous pleurisy, and carcinomatous lymphangitis.
•8\) PD\-L1 status has been confirmed by a central measurement institute.

Exclusion Criteria

•1\) Active multiple cancer. However, the following are excluded: (1\) Completely resected cancers: basal cell carcinoma, Stage I spinous cell carcinoma, intraepithelial carcinoma, intramucosal carcinoma, superficial bladder cancer, (2\) gastrointestinal tract cancer that has been curatively resected by ESD or EMR, and (3\) other cancers that have not recurred for more than 5 years.
•2\) Infectious diseases that require systemic treatment.
•3\) Complicated active gastrointestinal ulcer.
•4\) Patients must have poorly controlled hypertension (systolic blood pressure \>\=150 mmHg and/or diastolic blood pressure \>\=100 mmHg) despite the use of two or more antihypertensive agents.
•5\) Patients must have symptomatic congestive heart failure, unstable angina, or arrhythmia requiring treatment at the time of enrollment.
•6\) History of myocardial infarction within 1 year prior to enrollment.
•7\) Major surgery or incisional biopsy or significant trauma within 28 days prior to enrollment; placement of a CV port is not considered major surgery.
•8\) Patients with deep vein thrombosis or pulmonary embolism at the time of enrollment, or a history of such within 1 year prior to enrollment.
•9\) Use of anticoagulants (except aspirin of 324 mg/day or less) within 10 days prior to enrollment.
•10\) Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia (bronchiolitis obliterans, etc.), drug\-induced pneumonitis, or idiopathic pneumonitis. However, patients with a history of drug\-induced pneumonitis who are asymptomatic at the time of enrollment can be enrolled if they undergo regular chest X\-ray examinations and careful follow\-up including auscultation and medical examination.