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Selective Estrogen Receptor Degrader (SERD)
Camizestrant for Early Breast Cancer (CAMBRIA-1 Trial)
Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
CAMBRIA-1 Trial Summary
This trial tests if a new drug can improve outcomes in early breast cancer patients after standard endocrine therapy. Treatment can last up to 5 years.
Who is the study for?
This trial is for adults over 18 with ER+/HER2- early breast cancer at intermediate/high risk of recurrence, who've completed 2-5 years of standard endocrine therapy after surgery and possibly chemotherapy. They should be in good health with proper organ/marrow function and not have metastatic breast cancer or other severe diseases.Check my eligibility
What is being tested?
The study tests if camizestrant can improve outcomes compared to standard therapies like Tamoxifen, Anastrozole, Letrozole, or Exemestane in patients with certain types of early-stage breast cancer. Participants will receive treatment for up to five years to see which is more effective.See study design
What are the potential side effects?
While the specific side effects of camizestrant are not listed here, similar hormone therapies may cause hot flashes, mood swings, fatigue, joint pain and increase the risk of blood clots. The exact side effects will depend on individual patient reactions.
CAMBRIA-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is ER+ and HER2-, with a high or intermediate risk of coming back.
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I have completed treatment for my primary breast cancer, including surgery and possibly chemotherapy.
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I am fully active or can carry out light work.
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My breast cancer is ER+ and HER2-, removed surgically, and has a high or medium risk of coming back.
CAMBRIA-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Invasive breast cancer-free survival (IBCFS)
Secondary outcome measures
Absolute and percent change from baseline in Clinical Laboratory Parameters
Absolute and percent change from baseline in Vital Sign Parameters
Change from baseline and TTD (time to deterioration ) of health-related QoL (quality of life) as measured by the 2 global QoL items from the EORTC-QLQ-C30 items 11 and 12. EORTC-QLQ-C30 uses 0 - 4 scale (higher score is worse)
+12 moreCAMBRIA-1 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: camizestrantExperimental Treatment1 Intervention
Camizestrant
Group II: Arm A: standard endocrine therapy of investigator´s choiceActive Control4 Interventions
Continue standard endocrine therapy of investigator's choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Camizestrant
2023
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,608,375 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on hormone therapy for conditions not related to cancer.I have been cancer-free for at least 5 years, except for certain skin cancers or cervical carcinoma in situ.I finished my hormone therapy for cancer between 2 and 5 years ago.My breast cancer is ER+ and HER2-, with a high or intermediate risk of coming back.I have taken CDK4/6 inhibitors for 2 years as part of my previous treatment.Your heart's electrical activity is too slow at rest.My breast cancer cannot be removed by surgery and has spread.My cancer was completely removed with initial treatment before surgery.My heart's pumping ability is reduced, and I experience noticeable symptoms.You have a serious health condition that the doctor thinks makes it unsafe for you to be in the study or follow the rules.I am not allergic to camizestrant or similar drugs, and if I'm pre-/peri-menopausal or male, I'm not allergic to LHRH agonists.My organs and bone marrow are working well.I have completed treatment for my primary breast cancer, including surgery and possibly chemotherapy.I am fully active or can carry out light work.I am not on any cancer treatments not listed in the study, except for bone-strengthening drugs.I finished my hormone therapy for cancer between 2 and 5 years ago.I have not been treated with camizestrant, SERDs, ER targeting agents, or fulvestrant.My breast cancer is ER+ and HER2-, removed surgically, and has a high or medium risk of coming back.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: standard endocrine therapy of investigator´s choice
- Group 2: Arm B: camizestrant
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration granted authorization for Arm B: camizestrant?
"Our team has assessed the safety of camizestrant at a 3 out of 3 due to accumulated evidence from Phase III trials that have demonstrated both efficacy and safety."
Answered by AI
Is the enrollment period open for this research endeavor?
"Affirmative. The information hosted on clinicaltrials.gov attests that this trial is currently recruiting; it was first posted on March 31st 2023 and most recently updated April 24th 2023. A total of 4300 people are required to participate across 91 locations."
Answered by AI
What is the participant capacity of this research project?
"Affirmative. Clinicaltrials.gov attests that this trial, which was first put forward on March 31st 2023, is currently recruiting patients. Around 4300 participants will be admitted between 91 potential sites across the globe."
Answered by AI
What is the extent of this clinical trial's reach within the United States?
"This research project is currently accepting participants at 91 distinct clinical sites, ranging from Nashville to Buenos Aires and numerous other locales. To minimise travel time, it may be beneficial to select the clinic nearest you if you decide to join this study."
Answered by AI
Who else is applying?
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I am hoping this trial can help people get a treatment that will help.
PatientReceived 2+ prior treatments
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