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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 years

Awards & highlights

CAMBRIA-2 Trial 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.Check my eligibility

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.See study design

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.

CAMBRIA-2 Trial 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.

CAMBRIA-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 years

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

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

Change from baseline and time to deterioration of health-related quality of life as measured by the 2 global QoL items from the EORTC IL-311

Distant relapse-free survival (DRFS)

Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)

+4 more

CAMBRIA-2 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

~1710

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Austrian Breast and Colorectal Cancer Study Group (ABCSG)UNKNOWN

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,607,175 Total Patients Enrolled

174 Trials studying Breast Cancer

1,246,339 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research permit octogenarians to participate?

"This clinical trial includes individuals from the age of majority up to 130 years old."

Answered by AI

Is the enrollment procedure still active for this clinical trial?

"Evidenced on clinicaltrials.gov, this research experiment is presently enrolling participants with the initial posting having been uploaded to the site on October 5th 2023 and its most recent update occurring 10 days later."

Answered by AI

Has the combination of camizestrant and abemaciclib been sanctioned by the Food & Drug Administration?

"Our team at Power has rated Arm B: camizestrant ± abemaciclib with a score of 3 due to the existing clinical evidence that supports its efficacy as well as proven safety data."

Answered by AI

What is the maximum participant capacity of this research endeavor?

"Affirmative. According to clinicaltrials.gov, the trial posted on October 5th 2023 is still actively recruiting patients, with an update made as recently as October 13th 2023. A total of 5500 individuals will be accepted from 46 different medical sites across America."

Answered by AI

How widespread is the implementation of this trial?

"Currently, this medical trial is being conducted in 46 distinct cities. Columbus, Wilrijk and Porto Alegre are among those included in the list; however additional sites exist around multiple countries. To reduce potential travel costs for participants it may be advantageous to pick a location nearest them."

Answered by AI

Is it possible for me to join this medical experiment?

"This study is recruiting up to 5500 individuals aged 18-130 years with a confirmed diagnosis of ER+/HER2- early stage breast cancer. Inclusion criteria include: gender (men and women), completion of definitive local therapy, not more than 12 weeks of endocrine treatment prior to randomisation, ECOG performance status ≤ 1, and adequate organ and marrow function."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05952557.

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