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Association details:
| Biomarker: | ER positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Verzenio (abemaciclib) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A study of abemaciclib combined with endocrine therapy (letrozole or fulvestrant)with or without a short course of chemotherapy with paclitaxel in patients withunresectable locally advanced or metastatic breast cancer with aggressive disease criteria. Uno studio di abemaciclib combinato con la terapia endocrina (letrozolo o fulvestrante) con o senza un breve ciclo di chemioterapia con paclitaxel in pazienti con tumore al seno non resecabile localmente avanzato o metastatico con criteri di malattia aggressivi.
Excerpt:
...Histologically confirmed estrogen receptor-positive and/or progesteronereceptor (PgR)-positive and HER2-negative breast cancer based on local testing on the most recent analyzed biopsy.9. ...
Trial ID:
Source:
Title:
Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer
Excerpt:
...ER-positive by immunohistochemistry (IHC) (>10%) on primary or metastatic disease....
Trial ID:
More C2 evidence
Source:
Title:
Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.
Excerpt:
...- Estrogen-receptor positive and/or progesterone receptor positive breast cancer determined by immunohistochemistry (IHC) methods according to the local institution standard protocol...
Trial ID:
Source:
Title:
PreOperative Endocrine Therapy for Individualised Care With Abemaciclib
Excerpt:
...Tumour ER positive....
Trial ID:
Source:
Title:
Abemaciclib in Combination With Endocrine Therapy as First Line Therapy in Metastatic Breast Cancer Patients
Excerpt:
...Histologically proven diagnosed estrogen receptor positive, HER2 negative metastatic breast cancer...
Trial ID:
Source:
Title:
Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7)
Excerpt:
...Patient has a histological and/or cytological confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory....
Trial ID:
Source:
Title:
_ Étude comparant deux traitements standards en situation métastatique initiale chez les patientes atteintes d’un cancer du sein ER positif - HER2 négatif avec des métastases viscérales : chimiothérapie et hormonothérapie associée à l’abémaciclib
Excerpt:
...ER-positive by IHC (>10%) on primary or metastatic disease.8. ...
Trial ID:
Source:
Title:
Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer
Excerpt:
...Histologically confirmed ER-positive, HER2-negative metastatic breast cancer....
Trial ID:
Source:
Title:
Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC
Excerpt:
...Histologically confirmed diagnosis of primary estrogen-receptor positive and/or progesterone-receptor positive early breast cancer by local laboratory....
Trial ID:
Source:
Title:
Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer
Excerpt:
...Histologically documented estrogen receptor positive adenocarcinoma of the breast that is (any progesterone status allowed):...
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:
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)….
Secondary therapy:
GDC-9545
DOI:
10.1200/JCO.2023.41.16_suppl.1061
Trial ID:
Source:
Title:
Palbociclib , ribociclib and abemaciclib in real-world data: risk of disease progression on first-line treatment of metastatic breast cancer
Published date:
11/22/2022
Excerpt:
In our sample of patients with ER-positive HER2-negative metastatic breast cancer treated with the different CDK 4/6 inhibitors as front line therapy, patients with abemaciclib achieved a lower risk of progression and a trend toward longer PFS.
Source:
Title:
Efficacy of subsequent-abemaciclib treatment after disease progression on palbociclib combined with endocrine therapy in patients with ER-positive HER2-negative metastatic breast cancer
Published date:
11/22/2022
Excerpt:
In total, 81 patients with ER+/HER2- MBC were treated with palbociclib and ET at our medical center between December 2017 and November 2020. Among them, 25 patients who received subsequent-abemaciclib after disease progression on prior-palbociclib were included....Subsequent-abemaciclib after disease progression on prior- palbociclib resulted in an ORR and clinical benefit rate (CBR) of 16.0% (4/25) and 44.0% (11/25), respectively.
Source:
Title:
Open-label, phase 2, multicenter study of lasofoxifene (LAS) combined with abemaciclib (Abema) for treating pre- and postmenopausal women with locally advanced or metastatic ER+/HER2− breast cancer and an ESR1 mutation after progression on prior therapies.
Published date:
05/26/2022
Excerpt:
The censored median PFS was 13.9 mos (95% CI, 8.0‒NE), the ORR 33.3% (95% CI, 16.3‒56.3) with 6 confirmed partial responses, and the CBR 62.1% (95% CI, 44.0‒77.3)….LAS combined with Abema in the ELAINE 2 trial was well tolerated and demonstrated robust and meaningful efficacy in women with ER+/HER2- mBC..
Secondary therapy:
lasofoxifene
DOI:
10.1200/JCO.2022.40.16_suppl.1022
Trial ID:
Source:
Title:
Subsequent-abemaciclib Treatment After Disease Progression on Palbociclib in Patients With ER-positive HER2-negative Metastatic Breast Cancer
Published date:
02/01/2022
Excerpt:
This retrospective study based on 25 ER+/HER2– MBC patients reported the efficacy and predictive factors of subsequent-abemaciclib after disease progression on prior-palbociclib....The overall response rate and clinical benefit rate were 16.0% and 44.0%, respectively. The median progression-free survival (PFS) was 5.3 months. In multivariate analysis, the best overall response (BOR) to prior-palbociclib was the only independent predictive factor for PFS (p=0.015).
DOI:
https://doi.org/10.21873/anticanres.15572
Source:
Title:
A Case of Postoperative Pulmonary Metastasis of Breast Cancer with Complete Response by Abemaciclib plus Fulvestrant Therapy
Published date:
05/01/2022
Excerpt:
A 66-year-old woman underwent total mastectomy with level Ⅰ and Ⅱ axillary lymph node dissection for right breast cancer...that was estrogen receptor-positive and human epidermal growth factor 2-negative....the patient was switched to abemaciclib, with the dose reduced by 1 level initially and then reduced by 2 levels from August 2019. In June 2019, new multiple lung metastases appeared, and the patient was switched from ANA to fulvestrant, after which complete response was achieved in 6 months. CT in June 2021 showed no recurrence, and the patient(now 80-year-old)continues to take abemaciclib plus fulvestrant therapy.
Secondary therapy:
fulvestrant
