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Also known as Ribociclib 200Mg Oral Tablet
Ribociclib · 1 trial · 1 indication
superiority in invasive disease-free survival (iDFS) of ribociclib + ET vs. standard-of-care chemotherapy
distant disease-free survival (dDFS) in the ribociclib + ET-group to demonstrate survival rate \>92%
| Arm | Type | Description |
|---|---|---|
| Ribociclib plus ET | EXPERIMENTAL | Ribociclib 600mg / day over 26 cycles + endocrine treatment of physician´s choice |
| Standard-of-care chemotherapy | NO_INTERVENTION | Standard-of-care chemotherapy according to the clinical guidelines, e.g., of the Breast Committee of the German Gynecological Oncology Group (AGO), and regional prescribing information depending on patient's needs for 16-24 weeks, |
| Name | Type | Description |
|---|---|---|
| Ribociclib 200Mg Oral Tablet | DRUG | 3 x 200 MG per os |
Inclusion Criteria: Patients eligible for inclusion in this study have to meet all of the following criteria: A. Prior to REGISTRATION in the study: 1\. Written informed consent prior to any screening procedures. 2. Female. 3. ≥ 18 years of age. 4a. EITHER: (Post)menopausal status at the time of ...
Ribociclib is an investigational small molecule being studied for the treatment of breast cancer in females. It is currently in Phase 3 clinical development for this indication, specifically in a trial evaluating it in combination with endocrine therapy versus chemotherapy in intermediate risk, HR+/HER2- early breast cancer.
Ribociclib targets cyclin-dependent kinases (CDKs), as indicated by its '-ciclib' drug class. CDKs are enzymes that regulate cell cycle progression, and inhibiting them can slow the growth of cancer cells. This mechanism is being explored in the context of hormone receptor-positive, HER2-negative breast cancer.
Ribociclib is being developed by Exact Sciences Corporation, a company traded on the NASDAQ under the ticker EXAS. The company is conducting a Phase 3 clinical trial of this drug in patients with breast cancer.
Ribociclib is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is active but not recruiting participants, and it is designed to evaluate the drug's efficacy in a specific breast cancer population.
Ribociclib is being studied in one active Phase 3 clinical trial with the identifier NCT04055493. This trial, titled 'Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC,' is enrolling female patients aged 18 years and older with breast cancer in Germany. The trial has a planned enrollment of 1684 participants and is biomarker-selected.
Yes, Ribociclib is also known as Ribociclib 200Mg Oral Tablet. This alternative name refers to the specific oral tablet formulation of the drug at a 200 mg dose. Both names refer to the same investigational drug being developed for breast cancer.