AZD9833 for Breast Cancer

Research Site, Aurora, CO
Breast CancerAZD9833 - Drug
Eligibility
18 - 130
Female
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Study Summary

This trial is testing a new drug, AZD9833, to see if it can shrink tumors in women with a certain type of advanced breast cancer.

Eligible Conditions
  • Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: Weeks 8, 16 and 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year).

Year 1
Assessment of biomarker changes
Week 16
Area under the plasma concentration-time curve (AUC) for AZD9833 alone or in combination with Palbociclib, Everolimus, Abemaciclib or Capivasertib
Area under the plasma concentration-time curve (AUC) for AZD9833 alone or in combination with Palbociclib, Everolimus, Abemaciclib, Capivasertib, Ribociclib or Anastrozole
Maximum Observed Plasma Concentration (Cmax) of AZD9833 alone or in combination with Palbociclib, Everolimus, Abemaciclib or Capivasertib
Maximum Observed Plasma Concentration (Cmax) of AZD9833 alone or in combination with Palbociclib, Everolimus, Abemaciclib, Capivasertib, Ribociclib or Anastrozole
Renal clearance (CLR) for AZD9833
Time to observed Cmax (Tmax) for AZD9833 alone or in combination with Palbociclib, Everolimus, Abemaciclib or Capivasertib
Time to observed Cmax (Tmax) for AZD9833 alone or in combination with Palbociclib, Everolimus, Abemaciclib, Capivasertib, Ribociclib or Anastrozole
Year 1
The number of subjects with treatment-related adverse events as assessed by CTCAE v4.03.
Day 28
The number of subjects with dose-limiting toxicity, as defined in the protocol.
Up to 24 weeks
Clinical benefit rate at 24 weeks
Year 1
Duration of Response
Objective Response Rate
Percentage Change in Tumour Size
Progression Free Survival

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

16 Treatment Groups

AZD9833 with abemaciclib dose escalation
1 of 16
AZD9833 monotherapy dose expansion
1 of 16
AZD9833 with palbociclib dose escalation
1 of 16
AZD9833 with palbociclib dose expansion
1 of 16
AZD9833 with abemaciclib (± anastrozole) dose escalation
1 of 16
AZD9833 with abemaciclib (± anastrozole)dose expansion
1 of 16
AZD9833 with ribociclib (± anastrozole) dose escalation
1 of 16
AZD9833 with ribociclib (± anastrozole) dose expansion
1 of 16
AZD9833 with anastrozole dose escalation
1 of 16
AZD9833 with anastrozole dose expansion
1 of 16
AZD9833 monotherapy dose escalation
1 of 16
AZD9833 with abemaciclib dose expansion
1 of 16
AZD9833 with capivasertib dose expansion
1 of 16
AZD9833 with everolimus dose expansion
1 of 16
AZD9833 with everolimus dose escalation
1 of 16
AZD9833 with capivasertib dose escalation
1 of 16

Experimental Treatment

403 Total Participants · 16 Treatment Groups

Primary Treatment: AZD9833 · No Placebo Group · Phase 1

AZD9833 with abemaciclib dose escalation
Drug
Experimental Group · 1 Intervention: AZD9833 with abemaciclib · Intervention Types: Drug
AZD9833 monotherapy dose expansion
Drug
Experimental Group · 1 Intervention: AZD9833 · Intervention Types: Drug
AZD9833 with palbociclib dose escalation
Drug
Experimental Group · 1 Intervention: AZD9833 with palbociclib · Intervention Types: Drug
AZD9833 with palbociclib dose expansion
Drug
Experimental Group · 1 Intervention: AZD9833 with palbociclib · Intervention Types: Drug
AZD9833 with abemaciclib (± anastrozole) dose escalation
Drug
Experimental Group · 1 Intervention: AZD9833 with abemaciclib · Intervention Types: Drug
AZD9833 with abemaciclib (± anastrozole)dose expansion
Drug
Experimental Group · 1 Intervention: AZD9833 with abemaciclib · Intervention Types: Drug
AZD9833 with ribociclib (± anastrozole) dose escalation
Drug
Experimental Group · 1 Intervention: AZD9833 with ribociclib · Intervention Types: Drug
AZD9833 with ribociclib (± anastrozole) dose expansion
Drug
Experimental Group · 1 Intervention: AZD9833 with ribociclib · Intervention Types: Drug
AZD9833 with anastrozole dose escalation
Drug
Experimental Group · 1 Intervention: AZD9833 with anastrozole · Intervention Types: Drug
AZD9833 with anastrozole dose expansion
Drug
Experimental Group · 1 Intervention: AZD9833 with anastrozole · Intervention Types: Drug
AZD9833 monotherapy dose escalation
Drug
Experimental Group · 1 Intervention: AZD9833 · Intervention Types: Drug
AZD9833 with abemaciclib dose expansion
Drug
Experimental Group · 1 Intervention: AZD9833 with abemaciclib · Intervention Types: Drug
AZD9833 with capivasertib dose expansion
Drug
Experimental Group · 1 Intervention: AZD9833 with capivasertib · Intervention Types: Drug
AZD9833 with everolimus dose expansion
Drug
Experimental Group · 1 Intervention: AZD9833 with everolimus · Intervention Types: Drug
AZD9833 with everolimus dose escalation
Drug
Experimental Group · 1 Intervention: AZD9833 with everolimus · Intervention Types: Drug
AZD9833 with capivasertib dose escalation
Drug
Experimental Group · 1 Intervention: AZD9833 with capivasertib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD9833
2022
Completed Phase 1
~60

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 8, 16 and 24 and then every 12 weeks (weeks 36, 48 and 60) until the end of the study (approximately 1 year).

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,051 Previous Clinical Trials
240,384,463 Total Patients Enrolled
162 Trials studying Breast Cancer
1,237,166 Patients Enrolled for Breast Cancer
Richard Baird, MD PhD FRCPPrincipal InvestigatorBreast Cancer Research Unit, University of Cambridge
Justin Lindemann, MBChB MBAStudy DirectorAstraZeneca
1 Previous Clinical Trials
148 Total Patients Enrolled

Eligibility Criteria

Age 18 - 130 · Female Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your cancer has spread to other parts of your body or has come back and previous treatments have not worked or were not well-tolerated.
You are allowed to have received treatment with CDK4/6 inhibitors before.

Frequently Asked Questions

Is this study recruiting participants at the present time?

"Affirmative. According to the information accessible on clinicaltrials.gov, this medical experiment is currently recruiting participants which was first advertised and posted on October 11th 2018. 402 patients are needed for 5 distinct healthcare facilities." - Anonymous Online Contributor

Unverified Answer

What medical conditions most commonly necessitate treatment with AZD9833?

"AZD9833 is regularly prescribed to treat kidney transplant rejection, and it has also been found successful in combating waldenstrom macroglobulinemia, lung cancer, and advanced carcinoid tumors." - Anonymous Online Contributor

Unverified Answer

Is AZD9833 a reliable option for individuals seeking medical assistance?

"Our team is of the opinion that AZD9833 ranks low on the safety scale, being a mere 1. This is because it has only recently entered Phase 1 trials and there is still limited data regarding its efficacy." - Anonymous Online Contributor

Unverified Answer

How many healthcare providers are administering this trial?

"Presently, the trial is running in 5 different medical centres which are located across Nashville, Salt Lake City and Sarasota as well as two other cities. In order to minimize travel time if you do decide to participate, please select the clinic nearest your residence." - Anonymous Online Contributor

Unverified Answer

Is the research only available to those who are of legal age?

"To be eligible for this trial, individuals must between 18 and 130 years of age." - Anonymous Online Contributor

Unverified Answer

What is the size of the cohort testing this therapeutic intervention?

"Absolutely, the facts on clinicaltrials.gov demonstrate that this research initiative is presently recruiting patients. The study was initially announced on October 11th 2018 and has been recently updated as of November 21st 2022. This medical trial requires 402 individuals to be recruited from 5 different locations." - Anonymous Online Contributor

Unverified Answer

Has AZD9833 previously undergone experimental testing?

"AZD9833 was first examined in 2008 at Sheba Medical Center, and 520 trials have been concluded since then. At present, 310 clinical studies are currently active with a large number centred around Nashville Tennessee." - Anonymous Online Contributor

Unverified Answer

What objectives is the study attempting to achieve?

"The primary goal of this 28-day clinical trial is to evaluate the amount of adverse events caused by treatment. Additional objectives include monitoring Progression Free Survival, Clinical Benefit Rate at 24 weeks, and Renal Clearance for AZD9833 through urine sample collection." - Anonymous Online Contributor

Unverified Answer

Who is eligible to participate in this medical experiment?

"This medical trial is looking for 402 individuals to join their cohort, who must be between ages 18 and 130 with a diagnosis of breast cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.