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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | Hormone Receptor Positive Breast Cancer |
| Drug: | Verzenio (abemaciclib) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
U.S. FDA Broadens Indication for Verzenio® (abemaciclib) in HR+, HER2-, Node-Positive, High Risk Early Breast Cancer
Excerpt:
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Verzenio® (abemaciclib), in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at a high risk of recurrence.
Source:
Title:
Clinical trial to compare efficacy and safety of standard chemotherapy versus letrozole plus abemaciclib, chosen randomly, as neoadjuvant therapy (deliver before breast cancer surgery), with positive Hormone Receptors (female hormones) and negative HER2 (protein involved in cell division that is located in the surface of many cells), intermediate/high risk breast cancer Estudio clínico para comparar eficacia y seguridad de la quimioterapia estándar frente a letrozol más abemaciclib, asignado al azar, como terapia neoadyuvante (administrada antes de la cirugía del tumor de mama), en pacientes con cáncer de mama con receptores hormonales (hormonas femeninas) positivos y HER2 (proteína involucrada en la división celular que se encuentra en la superficie de numerosas células) negativo, de riesgo alto/intermedio
Excerpt:
...1.Written informed consent prior to any specific study procedures2.Women > or = 18 years of age3.Documentation of histologically confirmed primary invasive adenocarcinoma of the breast4.Availability of a primary tumor tissue sample obtained during the diagnostic process before treatment for the central assessment of Ki67 index5.Documentation of HR positive and HER2 negative BC based on local laboratory determination.a.HR positive is defined as more than or equal to 10% positive cells by IHC for ER and/or progesterone receptor (PgR)b.HER2 negative tumor is determined according to recommendations of ASCO/CAP 2018 guidelines6.Intermediate and high risk patients based on Ki67 index value (> or = 20%) determined at a central laboratory7.Patients should be in the following clinical stages of disease according to the 8th edition of the TNM Classification of Breast Cancer by the UICC (Union for International Cancer Control): T2 (> 2cm) – T3, T4b, N0 – N2, M0 (stages IIA, IIB, IIIA or IIIB). ...
Trial ID:
Source:
Title:
Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
Excerpt:
...- Have a diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer....
Trial ID:
More C2 evidence
Source:
Title:
Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management
Excerpt:
...Diagnosis of hormone receptor positive (HR+), HER2- breast cancer....
Trial ID:
Source:
Title:
A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread
Excerpt:
...- Have a diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer for Parts A to E, G, and I....
Trial ID:
Source:
Title:
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
Excerpt:
...- Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer...
Trial ID:
Source:
Title:
A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
Excerpt:
...- Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer...
Trial ID:
Source:
Title:
Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients
Excerpt:
...Documentation of Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative Breast Cancer (BC) based on local laboratory determination....
Trial ID:
Source:
Title:
Real-world Data in Patients With Breast Cancer Treated With Abemaciclib
Excerpt:
...- Histologically confirmed HR-positive, HER2-negative breast cancer...
Trial ID:
Source:
Title:
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain
Excerpt:
...- Have brain metastases secondary to hormone receptor positive breast cancer, NSCLC, or melanoma....
Trial ID:
Source:
Title:
A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread
Excerpt:
...- Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer....
Trial ID:
Source:
Title:
Randomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib (LY2835219) in Early Breast Cancer Patients
Excerpt:
...HR-positive (defined as either ER and or PR expression >10% by immunohistochemistry or by PCR) irrespective of HER2 status....
Trial ID:
Less C2 evidence
Source:
Title:
Clinical Outcomes With Abemaciclib After Prior CDK4/6 Inhibitor Progression in Breast Cancer: A Multicenter Experience
Published date:
03/24/2021
Excerpt:
We identified patients with HR+ MBC from 6 cancer centers in the United States....A subset of patients with HR+ MBC continue to derive clinical benefit from abemaciclib after progression on prior palbociclib.
DOI:
10.6004/jnccn.2020.7662
