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Camizestrant for Breast Cancer (CAMBRIA-2 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 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
Must not have
Inoperable locally advanced or metastatic breast cancer
Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 years
Awards & highlights

Summary

This trial studies if a new drug can help improve outcomes for breast cancer patients with a high risk of recurrence. Treatment lasts 7 years.

Who is the study for?
This trial is for adults with ER+/HER2- early-stage breast cancer that's been surgically removed, without signs of spreading. They should have finished primary treatment and can join within a year of surgery. Prior short-term endocrine therapy is okay. Participants need to be in good health with proper organ function.
What is being tested?
The study compares the effectiveness of Camizestrant against standard adjuvant endocrine therapies like Tamoxifen, Anastrozole, Letrozole, Exemestane, or Abemaciclib over 7 years in preventing breast cancer recurrence after initial treatment.
What are the potential side effects?
Potential side effects include those common to hormone therapies such as hot flashes, mood swings, fatigue and joint pain. There may also be risks specific to Camizestrant which are not yet fully known due to its investigational nature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is early-stage, ER+ and HER2-, with no signs of spreading.
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I have completed treatment for my breast cancer, including surgery and possibly chemotherapy.
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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast cancer cannot be removed by surgery and has spread.
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I am currently on hormone therapy for conditions not related to cancer.
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My heart's pumping ability is reduced, and I experience noticeable symptoms.
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I am allergic to camizestrant or similar drugs, and if female or male, cannot tolerate LHRH agonists.
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I have not been treated with camizestrant, SERDs, ER targeting agents, or fulvestrant.
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My cancer was completely removed with treatment before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Invasive breast cancer-free survival (IBCFS)
Secondary study objectives
Distant relapse-free survival (DRFS)
Invasive disease-free survival (IDFS)
Overall survival (OS)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: camizestrant ± abemaciclibExperimental Treatment2 Interventions
camizestrant ± abemaciclib
Group II: Arm A: standard endocrine therapy of investigator´s choice ± abemaciclibActive Control5 Interventions
standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) ± abemaciclib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Camizestrant
2023
Completed Phase 1
~40
Abemaciclib
2019
Completed Phase 2
~1800

Find a Location

Who is running the clinical trial?

Austrian Breast and Colorectal Cancer Study Group (ABCSG)UNKNOWN
AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,641,309 Total Patients Enrolled
176 Trials studying Breast Cancer
1,245,578 Patients Enrolled for Breast Cancer
~3667 spots leftby Mar 2030
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