348 Participants Needed

AZD8421 for Breast and Ovarian Cancer

(CYCAD-1 Trial)

Recruiting at 13 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot take any drugs that strongly affect liver enzymes (CYP3A4/5) or have a risk of causing heart rhythm problems (Torsades de Pointes). It's best to discuss your current medications with the trial team to see if any need to be stopped.

Is AZD8421 (Camizestrant) safe for use in humans?

The safety data for CDK4/6 inhibitors like abemaciclib, which is similar to AZD8421, shows that they are generally well-tolerated in humans. Common side effects include diarrhea, infections, and neutropenia (low white blood cell count), but these are manageable. Patient quality of life is maintained during treatment.12345

What makes the drug AZD8421 unique for treating breast and ovarian cancer?

AZD8421 is unique because it combines a new treatment with existing CDK4/6 inhibitors like abemaciclib, which are known to help control cancer cell growth by targeting specific proteins involved in cell division. This combination could potentially offer a more effective approach for patients with breast and ovarian cancer, especially those who have not responded well to other treatments.678910

What data supports the effectiveness of the drug AZD8421 for breast and ovarian cancer?

Research shows that CDK4/6 inhibitors like abemaciclib, ribociclib, and palbociclib, when combined with endocrine therapy, significantly improve progression-free survival in hormone receptor-positive breast cancer. These drugs are now a standard treatment for this type of cancer, suggesting potential effectiveness for similar treatments like AZD8421.68111213

Who Is on the Research Team?

RB

Richard Baird, MD, PhD

Principal Investigator

Cambridge University Hospitals

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have advanced cancer and have either been treated according to guidelines or a clinical trial is considered my best next treatment option.
My cancer has spread or returned and gotten worse after my last treatment.
I have at least one cancer lesion that can be measured and tracked over time.
See 2 more

Exclusion Criteria

I am not pregnant, breastfeeding, or planning to become pregnant and agree to use effective birth control.
I am not taking drugs that strongly affect liver enzymes and can't stop them for the study.
I don't have severe nausea, vomiting, or major gut surgery that affects medicine absorption.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD8421 alone or in combination with selected targeted anti-cancer drugs to evaluate safety, tolerability, and pharmacokinetics

6 months
Multiple visits at predefined intervals up to Cycle 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • AZD8421
  • Camizestrant
  • CDK4/6 Inhibitor
Trial Overview 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.
How Is the Trial Designed?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Published Research Related to This Trial

Palbociclib has been approved for treating hormone receptor-positive advanced breast cancer due to its ability to improve progression-free survival when used with endocrine agents, highlighting its efficacy in this patient population.
Abemaciclib and ribociclib, two other CDK4/6 inhibitors, are in late-stage clinical development and may offer different benefits, such as single-agent activity and central nervous system penetration, which could influence treatment choices and patient outcomes.
Clinical Development of the CDK4/6 Inhibitors Ribociclib and Abemaciclib in Breast Cancer.Barroso-Sousa, R., Shapiro, GI., Tolaney, SM.[2020]
The addition of CDK4 and 6 inhibitors (like abemaciclib, palbociclib, or ribociclib) to endocrine therapy significantly improves progression-free survival and response rates in patients with HR+ and HER2- metastatic breast cancer, establishing these inhibitors as a new standard of care.
Exploratory analyses suggest that abemaciclib may be particularly beneficial for women with poor prognosis indicators, although further confirmation is needed for these findings.
Abemaciclib, a CDK4 and CDK6 inhibitor for the treatment of metastatic breast cancer.Martin, M., Garcia-Saenz, JA., Manso, L., et al.[2021]
In a phase 1b study involving 50 patients with advanced non-small cell lung cancer (NSCLC), the combination of abemaciclib and pembrolizumab showed significant toxicity, with 80% of patients in cohort A and 76% in cohort B experiencing severe treatment-emergent adverse events.
Despite some antitumor activity, including a disease control rate of 56% in cohort A and 64% in cohort B, the overall risk-benefit profile of this combination therapy does not support further investigation in this patient population.
Abemaciclib in Combination With Pembrolizumab for Stage IV KRAS-Mutant or Squamous NSCLC: A Phase 1b Study.Pujol, JL., Vansteenkiste, J., Paz-Ares Rodríguez, L., et al.[2022]

Citations

Clinical Development of the CDK4/6 Inhibitors Ribociclib and Abemaciclib in Breast Cancer. [2020]
Abemaciclib, a CDK4 and CDK6 inhibitor for the treatment of metastatic breast cancer. [2021]
Abemaciclib in Combination With Pembrolizumab for Stage IV KRAS-Mutant or Squamous NSCLC: A Phase 1b Study. [2022]
Abemaciclib: The First FDA-Approved CDK4/6 Inhibitor for the Adjuvant Treatment of HR+ HER2- Early Breast Cancer. [2022]
A Randomized Phase I Study of Abemaciclib in Chinese Patients with Advanced and/or Metastatic Cancers. [2021]
Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence. [2023]
CDK4/6 Inhibitors Expand the Therapeutic Options in Breast Cancer: Palbociclib, Ribociclib and Abemaciclib. [2019]
Profile of abemaciclib and its potential in the treatment of breast cancer. [2020]
Real world incidence and management of adverse events in patients with HR+, HER2- metastatic breast cancer receiving CDK4 and 6 inhibitors in a United States community setting. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
nextMONARCH: Abemaciclib Monotherapy or Combined With Tamoxifen for Metastatic Breast Cancer. [2021]
Abemaciclib in Combination With Endocrine Therapy for Patients With Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer: A Phase 1b Study. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Abemaciclib: The Newest CDK4/6 Inhibitor for the Treatment of Breast Cancer. [2020]
Abemaciclib, a potent cyclin-dependent kinase 4 and 6 inhibitor, for treatment of ER-positive metastatic breast cancer. [2020]
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