CAMBRIA-2 Trial for Early-Stage Breast Cancer

Overview: The CAMBRIA-2 trial (Adjuvant Endocrine-based Therapy Study of Camizestrant [AZD9833] in ER+/HER2- Early Breast Cancer) is looking to see whether the experimental medicine camizestrant offers better outcomes than currently available hormonal therapy medicines after surgery for early-stage, estrogen receptor-positive, HER2-negative breast cancer with a medium or high risk of recurrence (the cancer coming back).

Phase: Phase III; Phase III trials compare the safety and effectiveness of a new treatment to the current standard of care. Phase III trials are usually large – some involve thousands of people – and are done at many places in the United States and around the world. 

Number of people to enroll: 5,500

ClinicalTrials.gov ID number: NCT05952557

Sponsor of the trial: AstraZeneca

The CAMBRIA-2 trial is for adults diagnosed with early-stage, estrogen receptor-positive, HER2-negative breast cancer who have had surgery to remove the cancer. People also may have received chemotherapy before or after surgery or radiation therapy. The breast cancer must have a medium or high risk of recurrence.

The CAMBRIA-2 study wants to see if the experimental medicine camizestrant, a type of hormonal therapy medicine called a selective estrogen degrader (SERD), offers better outcomes than standard hormonal therapy treatments – aromatase inhibitors or tamoxifen – after breast cancer surgery.

There will be two treatment groups in the study. All the medicines in the study are pills, taken by mouth.

The first group will take their doctor’s choice of hormonal therapy for seven years, which may be:

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  tamoxifen

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  Arimidex (chemical name: anastrozole)

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  Aromasin (chemical name: exemestane)

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  Femara (chemical name: letrozole)

People also may take Verzenio (chemical name: abemaciclib) along with their doctor’s choice of hormonal therapy.

The second group will take camizestrant for seven years and may also take Verzenio.

The people in the study will be followed for 10 years after the last person joins the study.

People are eligible for the CAMBRIA-2 study if they:

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  have had surgery to remove early-stage estrogen receptor-positive, HER2-negative invasive breast cancer

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  join the study within 12 months after breast cancer surgery

People are not eligible for the CAMBRIA-2 study if they:

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  have been diagnosed with inoperable or metastatic breast cancer

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  have a complete response to chemotherapy before surgery

Read the detailed eligibility requirements.

In previous studies, the most common side effects of camizestrant included:

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  nausea

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  vomiting

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  diarrhea

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  seeing flashes and floaters (photopsia)

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  slower-than-normal heart rate (bradycardia)

The side effects caused by the combination of camizestrant and Verzenio aren’t known.

Visit the tamoxifen, Arimidex, Aromasin, Femara, and Verzenio pages to read about their side effects.

The study is being conducted at multiple locations across the United States and around the world, including sites in Europe, South America, Australia, Canada, Asia, Central America, and Africa.

For a complete list of sites, visit: https://clinicaltrials.gov/study/NCT05952557#contacts-and-locations

Call the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or email information.center@astrazeneca.com.