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Association details:
| Biomarker: | ER positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Kisqali (ribociclib) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Effect of ribociclib plus fulvestrant on overall survival in the treatment of advanced breast cancer — updated MONALEESA-3 results
Published date:
05/27/2022
Excerpt:
...ER-positive/HER2-negative advanced breast cancer...Ribociclib with fulvestrant significantly prolonged progression-free survival and overall survival in the phase-III MONALEESA-3 trial. The newest update of the trial (after 56.3 months of observation) showed significant improvement in overall survival in the experimental arm for more than a year: mOS was 53.7 months in the ribociclib plus fulvestrant arm and 41.5 months in the placebo plus fulvestrant arm (risk reduction of 27%).
DOI:
10.5603/OCP2021.0034
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:
...ECOG Performance Status ≤ 2.Everolimus/ribociclib cohort (DIVa)• Indication for an endocrine therapy (Histological confirmation of estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) breast cancer).• Up to two lines of previous cytostatic treatment for MBC.• Any endocrine therapy in the history is allowed.• Cholesterol ≤ 2.0 × ULN.• Disease progression following prior treatment with endocrine therapy (endocrine therapy does not have to be the last therapy before inclusion in the trial).• Postmenopausal women. ...
Trial ID:
Source:
Title:
Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
Excerpt:
...- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive and HER2-negative breast cancer by local laboratory....
Trial ID:
More C2 evidence
Source:
Title:
Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer.
Excerpt:
...ER-positive and/or PgR-positive and HER2-negative tumor by ASCO/CAP guidelines assessed locally....
Trial ID:
Source:
Title:
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer
Excerpt:
...- Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer...
Trial ID:
Source:
Title:
Combined treatment (hormone and biological therapy) for patients with advanced breast cancer with hormone (HR) positive and HER2 negative receptors Trattamento combinato (terapia ormonale + biologica) per i pazienti con carcinoma mammario avanzato con recettori ormonali (HR) positivi ed HER2 negativo
Excerpt:
...Patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer by local laboratory. ...
Trial ID:
Source:
Title:
Study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2 negative advanced breast cancer on first-line treatment with ribociclib and letrozole Studio sulle caratteristiche molecolari di donne in post menopausa con carcinoma mammario avanzato positivo per il recettore ormonale (HR+) HER2 negativo, in trattamento di prima linea con ribociclib e letrozolo
Excerpt:
......
Trial ID:
Source:
Title:
CORALLEEN: A Phase 2 Clinical Trial of multi-agent Chemotherapy or letrozole plus Ribociclib (LEE001) as neoadjuvant treatment for postmenopausal patients with Luminal B/HER2-negative breast cancer. CORALLEEN: Ensayo clínico de fase 2 de poliquimioterapia o letrozol más ribociclib (LEE001) como tratamiento neoadyuvante en pacientes posmenopáusicas con cáncer de mama de tipo luminal B y HER2 negativo.
Excerpt:
...ER-positive and/or PgR-positive and HER2-negative tumor by ASCO/CAP guidelines assessed locally.9. ...
Trial ID:
Source:
Title:
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
Excerpt:
...Patient has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PgR-positive breast cancer based on the most recently analyzed tissue sample, and all tested by local laboratory....
Trial ID:
Source:
Title:
Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
Excerpt:
...- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory....
Trial ID:
Source:
Title:
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
Excerpt:
...- Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer...
Trial ID:
Source:
Title:
A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer
Excerpt:
...Estrogen-receptor-positive and/or progesterone receptor-positive breast cancer....
Trial ID:
Source:
Title:
Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.
Excerpt:
...- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor (ER) positive and/or progesterone receptor positive breast cancer by local laboratory (based on most recently analyzed biopsy)....
Trial ID:
Source:
Title:
A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer
Excerpt:
...- 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)....
Trial ID:
Source:
Title:
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Excerpt:
...- Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer...
Trial ID:
Source:
Title:
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Excerpt:
...- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer...
Trial ID:
Source:
Title:
Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer
Excerpt:
...- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer, HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+, and metastatic breast cancer...
Trial ID:
Source:
Title:
Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts
Excerpt:
...- Documentation of estrogen receptor (ER) positive and/or progesterone receptor (PR) positive tumor (≥1% positive stained cells) based on most recent tumor biopsy (discuss with the Principal Investigator if results in different biopsies are discordant in terms of hormone receptor positivity) utilizing an assay consistent with local standards....
Trial ID:
Source:
Title:
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
Excerpt:
...Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer....
Trial ID:
Source:
Title:
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
Excerpt:
...- Patient had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory....
Trial ID:
Source:
Title:
Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer
Excerpt:
......
Trial ID:
Source:
Title:
Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer
Excerpt:
...Most recent tumor biopsy or surgical resection specimen must be either estrogen-receptor (ER) positive, progesterone receptors (PgR) positive, or both, as defined by immunohistochemistry (IHC) ≥1% (as per the American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines)....
Trial ID:
Source:
Title:
FACILE: FeAsibility of First-line riboCIclib in oLdEr Patients With Advanced Breast Cancer
Excerpt:
...Patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer by local laboratory....
Trial ID:
Source:
Title:
Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
Excerpt:
...Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory....
Trial ID:
Source:
Title:
A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
Excerpt:
...- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer...
Trial ID:
Source:
Title:
Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC
Excerpt:
......
Trial ID:
Source:
Title:
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)
Excerpt:
......
Trial ID:
Source:
Title:
Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
Excerpt:
...Histologically confirmed estrogen receptor (ER) positive and/ or progesterone receptor (PgR) positive breast cancer determined by core biopsy according to local in-house standard....
Trial ID:
Source:
Title:
Neoadjuvant Treatment of Locally-advanced Breast Cancer Patients With Ribociclib and Letrozole
Excerpt:
...- ER-positive (defined by ER-pos....
Trial ID:
Source:
Title:
Managed Access Program to Provide Access to Ribociclib, for Locally Advanced or Metastatic Cancer Resistant or Refractory to Available Treatment Options and Candidate for Therapy With a CDK Inhibitor
Excerpt:
...Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory....
Source:
Title:
TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer
Excerpt:
...- Histologically and/or cytologically confirmed diagnosis of Estrogen Receptor-Positive (ER+) and/or Progesterone Receptor-Positive (PR+) breast cancer by local laboratory....
Trial ID:
Source:
Title:
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer
Excerpt:
...- Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer...
Trial ID:
Less C2 evidence
Source:
Title:
Interim analyses (IA) of the giredestrant (G), G + abemaciclib (A), and G + ribociclib (R) arms in MORPHEUS Breast Cancer (BC): A phase I/II study of G treatment (tx) combinations in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced/metastatic BC (ER+, HER2– LA/mBC).
Published date:
05/25/2023
Excerpt:
We present results from the 16-week IA of G and G + CDK4/6i (A or R)....MORPHEUS BC (NCT04802759) is evaluating the safety and efficacy of G tx combinations in ER+, HER2– LA/mBC. We present results from the 16-week IA of G and G + CDK4/6i (A or R)....Three pts had a partial response (PR; G + A, n = 1; G + R, n = 2); 19 had stable disease (G, n = 5; G + A, n = 7; G + R, n = 7). DCRs were 36% (G), 40% (G + A), and 50% (G + R)….This study provides the first data supporting the combinability of G with the CDK4/6is A and R...
Secondary therapy:
GDC-9545
DOI:
10.1200/JCO.2023.41.16_suppl.1061
Trial ID:
Source:
Title:
114P - Dose modifications of ribociclib and endocrine therapy for treatment of ER+ HER2- metastatic breast cancer
Published date:
05/03/2021
Excerpt:
...28 patients with ER+ HER2- MBC who initiated ribociclib treatment...Overall median PFS was 19.2 months (CI-95%: 14.3-NR). Patients with one or more dose reductions did not have decreased median PFS (19.2 months, CI-95%: 14.3-NR...Our results indicate that dose reduction of ribociclib is safe and do not compromise the efficacy of the treatment.
Source:
Title:
Dose modifications of ribociclib and endocrine therapy for treatment of ER+ HER2- metastatic breast cancer
Published date:
04/10/2021
Excerpt:
One hundred and twenty-eight patients with ER+ HER2- MBC who initiated ribociclib treatment between 1st of January 2018 to 31st of March 2020 were included in our analysis. Of these patients, 48.4% required one or more dose reductions. Overall median PFS was 19.2 months (CI-95% 14.3-NR.
Secondary therapy:
fulvestrant
DOI:
10.1007/s10549-021-06215-6
Source:
Title:
Letrozole + ribociclib versus letrozole + placebo as neoadjuvant therapy for ER+ breast cancer (FELINE trial).
Published date:
05/13/2020
Excerpt:
Postmenopausal women with >2 cm or node+ ER+ HER2- BC were randomized 1:1:1 between L+P, L+R 400 mg continuous dose (Rc) and L+R 600 mg...CCCA at D14C1 was observed in 52% vs. 92% in L+P, L+R respectively (p < 0.0001).
Secondary therapy:
letrozole
DOI:
10.1200/JCO.2020.38.15_suppl.505
Source:
Title:
Ribociclib therapy in peritoneal carcinomatosis secondary to HER2-negative metastatic breast cancer: A clinical case with a positive outcome
Published date:
07/25/2020
Excerpt:
Here, we report the clinical case of a woman with peritoneal carcinomatosis secondary to HER2‐negative estrogen receptor–positive breast cancer successfully treated with ribociclib and letrozole....After 9‐month follow‐up, total body computed tomography imaging showed resolution of hypodense areas surrounding the hepatic hilus with concomitant reduction in both bile duct dilatation and peritoneal effusion...
Secondary therapy:
letrozole
DOI:
https://doi.org/10.1111/tbj.13940
