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An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

Active: Yes
Cancer Type: Breast Cancer
Unknown Primary 		NCT ID: NCT05952557
Trial Phases: Phase III Protocol IDs: D8535C00001 (primary)
NCI-2023-06834
2023-504031-41-00
Eligibility: 18 - 130 Years, Male and Female Study Type: Treatment
Study Sponsor: AstraZeneca Pharmaceuticals LP
NCI Full Details: http://clinicaltrials.gov/show/NCT05952557

Summary

This is a Phase III open-label study to assess if camizestrant improves outcomes compared
to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer
with intermediate-high or high risk for disease recurrence who completed definitive
locoregional therapy (with or without chemotherapy). The planned duration of treatment in
either arm within the study will be 7 years.

Objectives

This is a Phase III open-label study to assess if camizestrant improves outcomes compared
to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer
with intermediate-high or high risk for disease recurrence who completed definitive
locoregional therapy (with or without chemotherapy). The planned duration of treatment in
either arm of the study is 7 years. Eligible patients must have intermediate-high or high
risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use
of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive
breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive
disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival
(OS), Safety and Clinical Outcome Assessments (COAs).

Patients will be followed for 10 years from randomization of the last patient.

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Cobb Hospital (Hiram)
144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com



Northwest Georgia Oncology Centers - Douglasville
6002 Professional Parkway
Suite 140
Douglasville, GA 30134
770-281-5101
www.ngoc.com



Northwest Georgia Oncology Centers - Tanner Medical Center Villa Rica
157 Clinic Avenue
Suite 202
Carrollton, GA 30117
770-281-5101
www.ngoc.com



Northwest Georgia Oncology Centers (NGOC) - Cobb Hospital (Marietta)
340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101


Study Coordinator:
Kristine Parker
770-281-5101


Piedmont Cancer Institute - Atlanta
1800 Howell Mill Road
Suite 800
Atlanta, GA 30318
678-298-3238
www.piedmontcancerinstitute.com



Piedmont Cancer Institute - Fayetteville
1267 Highway 54 West
Suite 4200
Fayetteville, GA 30214
678-298-3238
www.piedmontcancerinstitute.com



Piedmont Cancer Institute - Newnan
775 Poplar Road
Suite 310
Newnan, GA 30265
678-298-3238
www.piedmontcancerinstitute.com



Piedmont Cancer Institute – Sandy Springs
Piedmont Cancer Institute – Sandy Springs
755 Mount Vernon Hwy
Suite 320
Atlanta, GA 30328




Piedmont Cancer Institute - Stockbridge
290 Country Club Drive
Suite 100
Stockbridge, GA 30281
678-298-3238
www.piedmontcancerinstitute.com



Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.