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 range70 Years
SexFEMALE
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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…