What side effects are associated with this type of intervention?

Common treatments for breast cancer, including endocrine therapies like tamoxifen and aromatase inhibitors, and targeted therapies such as trastuzumab, have various side effects. Tamoxifen may cause hot flashes, vaginal dryness, and an increased risk of blood clots and endometrial cancer. Aromatase inhibitors can lead to bone density loss, fractures, and cardiovascular risks. Trastuzumab is generally well tolerated but can cause chills, fever, nausea, and serious cardiac dysfunction. These side effects should be carefully considered when selecting a treatment plan.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for breast cancer, particularly for ER+HER2- subtypes. These include hormone therapies like tamoxifen and aromatase inhibitors (letrozole, anastrozole) that block estrogen receptors or reduce estrogen production. Additionally, CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib) have been approved to inhibit cell cycle progression in hormone receptor-positive breast cancer. HER2-targeted therapies such as trastuzumab and pertuzumab are used for HER2-positive breast cancer, though not directly relevant to ER+HER2- subtypes. These treatments aim to interfere with specific molecular pathways critical for cancer cell growth and survival.

What other types of research exist?

Promising novel alternatives to AZD8421 for breast cancer patients in 2024 include: 1) Trastuzumab deruxtecan (Enhertu), an antibody-drug conjugate targeting HER2-positive breast cancer. 2) Sacituzumab govitecan (Trodelvy), an antibody-drug conjugate targeting Trop-2 in triple-negative breast cancer. 3) Alpelisib (Piqray), a PI3K inhibitor for HR-positive, HER2-negative breast cancer with PIK3CA mutations. 4) Pembrolizumab (Keytruda), an immune checkpoint inhibitor for PD-L1 positive triple-negative breast cancer. These therapies have shown significant efficacy in clinical trials and are considered promising options for breast cancer treatment.

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AZD8421 for Breast and Ovarian Cancer (CYCAD-1 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting IMP

At least one lesion that is measurable and/or non-measurable, as per RECIST v1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment

Must not have

Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, or previous significant bowel resection that would preclude adequate absorption of IMP(s)

Use of drugs known to be moderate or strong inhibitors/inducers of CYP3A4/5 which cannot be discontinued prior to first dose of IMP and withheld throughout the study until 2 weeks after the last dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment, at predefined intervals throughout the administration of azd8421 until end of treatment, approximately 18 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, AZD8421, alone and with other cancer drugs in patients with advanced breast and ovarian cancer who haven't responded well to standard treatments. The goal is to see if it is safe and effective in controlling cancer growth.

Who is the study for?

This trial is for adults with advanced breast cancer that's ER+HER2- or metastatic high-grade serious ovarian cancer. Participants must have measurable disease and be able to swallow pills. They should not have had certain treatments before, and their body should be functioning well enough to handle the study drugs.

What is being tested?

The study tests AZD8421 alone or combined with other targeted drugs like Palbociclib, Camizestrant, Ribociclib, or Abemaciclib in patients. It aims to find out how safe these treatments are and how well they work against specific types of advanced cancers.

What are the potential side effects?

Potential side effects may include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver issues, hair loss, diarrhea or constipation. Each drug has its own profile of possible side effects.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread or returned and gotten worse after my last treatment.

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I have at least one cancer lesion that can be measured and tracked over time.

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I am a woman aged 18 or older.

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I am mostly active and my doctor expects me to live at least 12 more weeks.

Exclusion Criteria

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

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I don't have severe nausea, vomiting, or major gut surgery that affects medicine absorption.

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I am not taking drugs that strongly affect liver enzymes and can't stop them for the study.

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I have heart issues like abnormal ECG, low heart function, or recent serious heart conditions.

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My high blood pressure is not under control.

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My blood tests show my bone marrow or organs are not working well.

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I haven't taken any cancer drugs or been in a cancer study for at least 14 days.

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I am not taking medication known to increase the risk of a specific heart rhythm problem.

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I haven't had major surgery or serious injury in the last 4 weeks and don't expect to need any during the study.

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I do not have severe illnesses like uncontrolled high blood pressure, active bleeding, or infections such as hepatitis or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment, at predefined intervals throughout the administration of azd8421 until end of treatment, approximately 18 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment, at predefined intervals throughout the administration of azd8421 until end of treatment, approximately 18 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment, at predefined intervals throughout the administration of azd8421 until end of treatment, approximately 18 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinically significant changes from baseline in clinical laboratory parameters, vital signs and ECGs.

Discontinuation of AZD8421 due to toxicity

Incidence of AEs/SAEs

+1 more

Secondary study objectives

Disease control rate (DCR)

Duration of Response (DoR)

Overall Response Rate (ORR)

+26 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Module 2A_riboExperimental Treatment3 Interventions

AZD8421 with camizestrant and ribociclib

Group II: Module 2A_palboExperimental Treatment3 Interventions

AZD8421 with camizestrant and palbociclib

Group III: Module 2A_abemaExperimental Treatment3 Interventions

AZD8421 with camizestrant and abemaciclib

Group IV: Module 1Experimental Treatment1 Intervention

AZD8421 monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Camizestrant

2023

Completed Phase 1

~40

Palbociclib

2017

Completed Phase 3

~3790

Abemaciclib

2019

Completed Phase 2

~1890

Ribociclib

2018

Completed Phase 3

~2420

0 / 13Eligibility 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

Common treatments for breast cancer include hormone therapy, chemotherapy, targeted therapy, and immunotherapy. Hormone therapies block hormones that promote cancer growth, while chemotherapy uses cytotoxic drugs to kill rapidly dividing cells. Targeted therapies, such as HER2 inhibitors and CDK4/6 inhibitors, focus on specific molecular pathways crucial for cancer cell survival. Immunotherapy helps the immune system recognize and attack cancer cells. Understanding these mechanisms allows for personalized treatment plans, potentially improving efficacy and minimizing side effects.

Factors influencing the interim interpretation of a breast cancer trial: danger of achieving the "expected" result.Moving Synergistically Acting Drug Combinations to the Clinic by Comparing Sequential versus Simultaneous Drug Administrations.