A Phase III Study of Bevacizumab and Paclitaxel in Combination With Atezolizumab as a Treatment f… (NCT04732598) | Clinical Trial Compass
CompletedPhase 3
A Phase III Study of Bevacizumab and Paclitaxel in Combination With Atezolizumab as a Treatment for Locally Advanced Unresectable or Metastatic Hormone Receptor-positive HER2 Negative Breast Cancer
Japan281 participantsStarted 2021-01-21
Plain-language summary
JCOG1919E (AMBITION) is a randomized, open-label, phase 3 trial to evaluate efficacy and safety of bevacizumab and paclitaxel in combination with atezolizumab comparing to bevacizumab and paclitaxel in patients with HR-positive HER2 negative metastatic breast cancer.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically diagnosed as breast cancer (invasive cancer).
✓. 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.
✓. Diagnosed with advanced recurrent breast cancer (either unresectable locally advanced breast cancer, recurrent breast cancer, or Stage IV breast cancer).
✓. Age 20 years or older on the date of registration. Either male or female are acceptable.
✓. ECOG performance status (PS) of 0-2.
✓. Patients must have measurable lesions.
✓. Hormone refractory\[\*a\] or life-threatening metastases \[\*b\].
✓. 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.
Exclusion criteria
✕. Active multiple cancer. However, the following are excluded: ①Completely 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.
✕. Infectious diseases that require systemic treatment.
What they're measuring
1
Progression-free Survival (investigator-assessed)
Timeframe: Up to 2years after last patient enrolled
✕. 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.
✕. Patients must have symptomatic congestive heart failure, unstable angina, or arrhythmia requiring treatment at the time of enrollment.
✕. History of myocardial infarction within 1 year prior to enrollment.
✕. Major surgery or incisional biopsy or significant trauma within 28 days prior to enrollment; placement of a CV port is not considered major surgery.
✕. Patients with deep vein thrombosis or pulmonary embolism at the time of enrollment, or a history of such within 1 year prior to enrollment.