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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | Hormone Receptor Positive Breast Cancer |
| Drug: | Kisqali (ribociclib) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
07/17/2015
Excerpt:
Kisqali is indicated for the treatment of women with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
Secondary therapy:
fulvestrant; Aromatase inhibitor
Source:
Title:
Treatment with ribociclib shows favourable immunomodulatory effects in patients with hormone receptor-positive breast cancer—findings from the RIBECCA trial
Published date:
12/23/2021
Excerpt:
Here, we investigated peripheral immune responses to ribociclib in patients with metastatic HR+ breast cancer as a preplanned exploratory subanalysis of the RIBECCA trial….Profiling of peripheral immune cell subpopulations showed a decrease in Treg cell frequencies, which was associated with treatment response....We show that treatment with ribociclib has significant effects on the peripheral innate and adaptive immune response in patients with HR+ breast cancer.
DOI:
https://doi.org/10.1016/j.ejca.2021.11.025
Trial ID:
Source:
Title:
144P - Patient-reported outcomes (PROs) in advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL) as first-line (1L) and second-line (2L) therapy in MONALEESA-3 (ML-3)
Published date:
05/24/2020
Excerpt:
These results, along with PFS and OS benefits observed with RIB, support use of RIB + FUL as 1L or 2L therapy to treat HR+/HER2− ABC.
Secondary therapy:
fulvestrant
Trial ID:
Source:
Title:
Cyclin-dependent kinase 4/6 inhibitors in combination with fulvestrant for previously treated metastatic hormone receptor-positive breast cancer patients: A systematic review and meta-analysis of randomized clinical trials
Published date:
05/04/2020
Excerpt:
To compare the efficacy and safety profile of the combination of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors and fulvestrant versus fulvestrant alone in previously treated patients with advanced hormone-receptor positive breast cancer. Use of abemaciclib, palbociclib, or ribociclib in combination with fulvestrant was significantly associated with longer PFS compared to use of fulvestrant alone...
Secondary therapy:
fulvestrant
DOI:
10.1016/j.ctarc.2020.100175
Source:
Title:
DetectIV - Treatment of patients with advanced metastatic breast cancer and circulating blood cells devoid of Her2/neu. DetectIV - Behandlung von Patientinnen mit metastierendem Brustkrebs, bei denen die im zirkulierenden Tumorzellen kein Her2/neu aufweisen.
Excerpt:
...The investigator must confirm postmenopausal statusPostmenopausal status is defined either by- Age ≥ 55 years and one year or more of amenorrhea- Age < 55 years and one year or more of amenorrhea and postmenopausal levels of FSH and LH- Prior hysterectomy and has postmenopausal levels of FSH and LH- Surgical menopause with bilateral oophorectomyEverolimus cohort:• Cholesterol ≤ 2.0 × ULNRibociclib cohort:• Standard 12-lead ECG values assessed by the local laboratory:- QTcF interval at screening < 450 msec (us-ing Fridericia’s correction)- Resting heart rate 50-90 bpm• INR ≤ 1,5 (ribocilclib cohort)• Patients must have the following laboratory values within normal limits or corrected to within normal limits with supplemets before the first dose of study medication:-Sodium-Potassium-Total calcium Eribulin cohort (DIVb)• Either hormone-receptor negative MBC or hormone-receptor positive MBC with indication for chemotherapy• Up to three previous chemotherapy treatment lines for metastatic disease• In case of patients of child bearing potential:- Negative pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) within 7 days prior to recruitment- Contraception by means of a reliable method (i.e. non-hormonal contraception, IUD, a double barrier method, vasectomy of the sexual partner, complete sexual abstinence). ...
Trial ID:
Source:
Title:
Ribociclib combined with hormone therapy versus chemotherapy as first line treatment for advanced breast cancer with visceral disease. A multicenter, randomized phase III trial.
Excerpt:
...Histologically or cytologically confirmed diagnosis of hormone receptor positive (ER+ ≥10%), HER2 negative, metastatic breast cancer.2. ...
Trial ID:
More C2 evidence
Source:
Title:
Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Excerpt:
...- Histologically confirmed unresectable, locally advanced or metastatic invasive breast cancer with hormone receptor positive/HER2 negative...
Trial ID:
Source:
Title:
Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC
Excerpt:
...- Histologically or cytologically confirmed diagnosis of HR-positive (ER+ ≥10%), HER2-negative advanced stage breast cancer...
Trial ID:
Source:
Title:
Kisqali Access Registry for Metastatic Breast Cancer in Australia
Excerpt:
...• Patients with metastatic or advanced HR positive, HER2 –ve breast cancer who have received combination treatment with ribociclib and an aromatase inhibitor as part of the Novartis ribociclib MAP/SPARK program between the period of 1 May 2017 to 30 June 2018...
Trial ID:
Less C2 evidence
Source:
Title:
32P - The neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios predict efficacy of CDK 4/6 inhibitors in women with hormone receptor-positive/HER2-negative advanced breast cancer
Published date:
05/23/2020
Excerpt:
CONTRADICTING EVIDENCE: This is the first study to show a significant association between high NLR or PLR values, as measured during CDK 4/6 inhibitor treatment, and lower PFS in HR+ aBC pts.
