Information sheet on the clinical trial - CAMBRIA-1

Main indication

Breast cancer

 

Study name (study type)

CAMBRIA-01 - Phase III study

Study sponsor

AstraZeneca

Registration number

FOR RAPID READERS:

CAMBRIA-1 is a Phase III study designed to determine whether treatment with camizestrant is safe and more effective than currently available treatments in people with early-stage ER+/HER2- breast cancer.

DETAILED INFORMATION:

This is a randomized, open-label Phase III trial. Randomized means that a computer program randomly assigns each participant to continue receiving standard endocrine therapy or to start taking camizestrant. Open-label means that each participant, their doctors, and the study staff know which treatment they are receiving. Participants will take the study treatment for 5 years. Participants will stop the study treatment earlier if their breast cancer returns, an investigator decides the treatment is no longer helpful, they experience an unacceptable adverse event, they need to start a new cancer treatment, or for other reasons. 

Study Title:

An open-label, randomized Phase III study to evaluate the efficacy and safety of extended therapy with camizestrant (AZD9833, a next-generation selective oral estrogen receptor modulator) compared to standard endocrine therapy (aromatase inhibitor or tamoxifen) in patients with early-stage ER+/HER2- breast cancer and intermediate or high risk of recurrence who have completed definitive locoregional therapy and at least 2 years of additional standard endocrine therapy without disease recurrence. 

Which conditions are being treated in this study?

Breast cancer

Are specific subgroups of patients with one of the mentioned conditions being treated?

Patients with ER+/HER2- early-stage breast cancer

Background on the study medication

The investigational drug camizestrant is designed to block the effects of estrogen. Researchers believe that treatment with camizestrant may be more effective than standard endocrine therapy in helping patients with early-stage ER+/HER2- breast cancer avoid cancer recurrence. 

Study Protocol

This study will enroll approximately 4,300 participants with early-stage ER+/HER2- breast cancer. Participants must have undergone surgery to remove their cancer and then completed 2 to 5 years of standard endocrine therapy without their cancer returning. Enrolled participants have breast cancer with a moderate or high risk of recurrence. 

During the study, doctors will monitor participants’ health and ask them to complete questionnaires.

Inclusion Criteria

• Patients with early-stage ER+/HER2- breast cancer
• Patients who are 18 years of age or older

Exclusion criteria

• Patients with any contraindications
• The patient is currently participating in another clinical trial and is receiving active treatment

Your contacts: Investigators at the center and contact information

Dr. Andriana Haus

Email: haus@~@gp-ruesselsheim.de

Phone: 06142 88-1223

Staff members in charge at the study clinic

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032