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 range
20 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free Survival (investigator-assessed)
Timeframe: Up to 2years after last patient enrolled
. 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.
. Complicated active gastrointestinal ulcer.
. 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.