What side effects are associated with this type of intervention?

Common side effects of endocrine therapies for breast cancer, including Selective Estrogen Receptor Degraders (SERDs) like Camizestrant, can include hot flashes, fatigue, nausea, and joint pain. Selective Estrogen Receptor Modulators (SERMs) such as tamoxifen may cause hot flashes, an increased risk of blood clots, and endometrial cancer. Aromatase inhibitors are associated with bone density loss, increased fracture risk, and cardiovascular issues. These side effects are important considerations for patients undergoing endocrine therapy for breast cancer.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of ER+/HER2- breast cancer, focusing on endocrine therapies. Selective Estrogen Receptor Degraders (SERDs) like fulvestrant have been approved for patients with hormone receptor-positive metastatic breast cancer. Other endocrine therapies include aromatase inhibitors such as letrozole, anastrozole, and exemestane, which reduce estrogen levels in postmenopausal women. Additionally, selective estrogen receptor modulators (SERMs) like tamoxifen are commonly used. These treatments aim to block or degrade estrogen receptors, thereby inhibiting the growth of hormone receptor-positive breast cancer cells.

What other types of research exist?

Promising novel alternatives to Camizestrant for ER+/HER2- breast cancer patients include: 1) Elacestrant, another SERD that has shown positive results in clinical trials. 2) CDK4/6 inhibitors like Abemaciclib, which are often used in combination with endocrine therapy. 3) PI3K inhibitors such as Alpelisib, particularly for patients with PIK3CA mutations. 4) mTOR inhibitors like Everolimus, which can be combined with endocrine therapy to improve outcomes.

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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

Must not have

Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions

Inoperable locally advanced or metastatic breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing camizestrant, a drug that blocks estrogen, in patients with ER+/HER2- early breast cancer at medium to high risk of recurrence. The goal is to see if it works better than standard hormone treatments by stopping cancer cells from growing.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on hormone therapy for conditions not related to cancer.

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My breast cancer cannot be removed by surgery and has spread.

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My cancer was completely removed with initial treatment before surgery.

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My heart's pumping ability is reduced, and I experience noticeable symptoms.

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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.

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I have not been treated with camizestrant, SERDs, ER targeting agents, or fulvestrant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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

Awards & Highlights

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.

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments often target the hormonal pathways that fuel cancer growth, particularly in estrogen receptor-positive (ER+) breast cancer. Selective Estrogen Receptor Degraders (SERDs) like Camizestrant work by binding to estrogen receptors on cancer cells, leading to their degradation and preventing estrogen from promoting cancer cell growth. This is crucial for patients as it directly targets the hormonal drivers of their cancer, potentially improving outcomes and reducing recurrence. Other common treatments include aromatase inhibitors, which lower estrogen levels in the body, and selective estrogen receptor modulators (SERMs) like tamoxifen, which block estrogen receptors. Chemotherapy and targeted therapies, such as HER2 inhibitors, are also used to kill cancer cells or block specific pathways involved in cancer progression. Understanding these mechanisms helps in tailoring treatment plans to effectively manage and treat breast cancer.