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Module 2A_palbo for Breast 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

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

CYCAD-1 Trial Summary

This trial aims to test a new drug called AZD8421 for patients with advanced breast cancer and metastatic ovarian cancer. The drug will be tested alone and in combination with other drugs that target cancer

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.Check my eligibility

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.See study design

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.

CYCAD-1 Trial 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.

CYCAD-1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Disease control rate (DCR)

Duration of Response (DoR)

Overall Response Rate (ORR)

+26 more

CYCAD-1 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

~3760

Abemaciclib

2019

Completed Phase 2

~1710

Ribociclib

2018

Completed Phase 3

~2330

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,499 Total Patients Enrolled

174 Trials studying Breast Cancer

1,246,339 Patients Enrolled for Breast Cancer

Richard Baird, MD, PhDStudy ChairCambridge University Hospitals

Frequently Asked Questions

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

In how many diverse venues is this experimental examination currently being conducted?

"Currently, there are 5 clinical trial sites actively enrolling patients. These sites are located in Saint Louis, Conroe, East Melbourne, and additional locations in other cities as well. When considering enrollment, it is advisable to choose the site nearest to your location in order to reduce travel obligations."

Answered by AI

What is the current number of individuals who are being enrolled in this medical study?

"Indeed, the data available on clinicaltrials.gov confirms that this trial is actively seeking eligible candidates. The initial posting of the clinical trial was made on December 5th, 2023 and it was most recently updated on December 18th, 2023. A total of five sites are enrolling a combined number of 204 participants for this study."

Answered by AI

Are individuals currently being enrolled for participation in this research study?

"Indeed, as per the details provided on clinicaltrials.gov, this trial is actively seeking participants. The initial posting of the trial was on December 5th, 2023 and it underwent its most recent update on December 18th, 2023. To complete the study, a total of 204 patients will be recruited from five different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

2023. "A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06188520.

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