Camizestrant Versus Standard Endocrine Therapy as Adjuvant Treatment in ER+/HER2- Early Breast Cancer

What is the Purpose of this Study?

The purpose of this study is to evaluate an experimental drug called camizestrant in people diagnosed with estrogen receptor-positive, human epidermal growth factor receptor 2- negative (ER+/HER2-) early-stage breast cancer who have an intermediate or high risk of recurrence and no evidence of disease following surgery. Camizestrant is a type of endocrine therapy (also called an oral selective estrogen receptor degrader), which is taken as a daily pill. Breast cancers that use estrogen to grow are called hormone receptor-positive and consist of cells with many receptors in them called estrogen receptors. Using these receptors, estrogen attaches to the breast cancer cells and sends messages, which tell the cancer cells to continue growing and multiplying. Camizestrant works by breaking down the estrogen receptors in cells. It also works by binding to the estrogen receptors and blocking them from being triggered by estrogen, which may help stop the patient’s cancer from coming back. Several studies demonstrated that camizestrant was superior to the current standard care endocrine therapy in advanced-stage breast cancer. Researchers aim to determine whether treatment with camizestrant is better at preventing disease recurrence (disease that comes back) than standard endocrine therapy (letrozole, anastrozole, exemestane or tamoxifen) in high risk early-stage breast cancer. Another drug, abemaciclib, may be added to camizestrant and endocrine therapy per the study doctor’s choice and local standard of care.


Eligibility

  • * Women and Men; ≥18 years at the time of screening (or per national guidelines)
  • * Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.
  • * Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.
  • * Patients must be randomised within 12 months of definitive breast surgery.
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Where can I participate?

  • CS Cancer at Cedars-Sinai Medical Center : Nikki Kem-Bernard
  • Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer


More about this Clinical Trial

What is the full name of this clinical trial?

D8535C00001 CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant Versus Standard Endocrine Therapy as Adjuvant Treatment for Patients with ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

Study Details
Disease Type/Condition

Breast

Principal Investigator

Bitar, Jin Sun

Co-Investigators

Alice Chung, Amin Mirhadi, Andrew Horodner, Armando Giuliano, Catherine Dang, David Chan, Farin Amersi, Hugo Hool, Justin Wayne Tiulim, Michele Burnison, Scott Karlan, Stephen Shiao, Swati Sikaria, Syed Jilani, Thomas Lowe, Vanessa Dickey, Yuan Yuan

Age Group

Adult

Phase

III

IRB Number

STUDY00003145

ClinicalTrials.gov ID

NCT05952557

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Nikki Kem-Bernard

Email
Nikki.Bernard@cshs.org
Study Detail
Disease Type/Condition

Breast

Principal Investigator

Bitar, Jin Sun

Age Group

Adult

Phase

III

IRB Number

D8535C00001/AFT-66

ClinicalTrials.gov ID

NCT05952557

Key Eligibility
ClinicalTrials.gov

Contact
Name

Nikki Kem-Bernard

Email
Nikki.Bernard@cshs.org