A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Bre… (NCT03956654) | Clinical Trial Compass
CompletedNot Applicable
A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer
Belgium78 participantsStarted 2018-12-11
Plain-language summary
The RibOB study is a prospective, open lable, single arm trial which will evaluate the clinical efficacy, overall safety and tolerability of ribociclib in combination with letrozole in older women (≥70 years) with HR+/HER2- aBC and no prior hormonal treatment for advanced disease (as per approved indication).
Who can participate
Age range
70 Years
Sex
FEMALE
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:
* Patient is a female ≥ 70 years old at the time of informed consent.
* Advanced breast cancer (defined as locoregionally recurrent or metastatic not amenable to curative therapy).
* Histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory (defined as ER and/or PgR ≥1% or Allred \>2).
* HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test as determined by local laboratory testing according to ASCO-CAP guidelines is necessary.
* Patient has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by local laboratory), preferably tested a maximum of 14 days before enrolment:
* Patient has signed informed consent obtained before any trial-related activities and according to local guidelines.
* Subjects must be able to communicate with the investigator and comply with the requirements of the study procedures.
Exclusion Criteria:
* Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole.
* Patients who received any CDK4/6 inhibitor previously.
* Patient who received any prior systemic antihormonal therapy or chemotherapy for advanced breast cancer.
* Patient is concurrently using other systemic anti-cancer therapy (except bone modifying agents).
* Patient w…
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.