Cohort B for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast Cancer+1 More
Neoadjuvant combination therapy with olaparib plus durvalumab - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study to learn more about olaparib and olaparib plus durvalumab combination therapy and also to better understand the studied disease, breast cancer, and associated health problems. Olaparib is a type of drug called a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor. PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. Olaparib is also approved by US Food and Drug Administration (FDA), European Medicines Agency (EMA) and in other countries for treating women with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. Durvalumab is a type of anticancer drug called immunotherapy that targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell. Your immune system can then attack and kill the cancer cells. Durvalumab is approved by the FDA and the EMA for the treatment of patients with locally advanced non-small cell lung cancer after receiving chemoradiation therapy and extensive-stage small cell lung cancer in combination with chemotherapy. Some parts of this study are experimental, which means that durvalumab and the combination of olaparib and durvalumab are still in the development stage for the treatment of breast cancer, and they are not approved for treatment of breast cancer, except for use in research studies like this.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Approx. 3 years

Approx. 3 years
To evaluate the efficacy of olaparib monotherapy and olaparib plus durvalumab combination therapy by assessment of EFS (event-free survival).
Month 6
Combined Modality Therapy
To evaluate the efficacy, measured by RCB (residual cancer burden), of olaparib monotherapy and olaparib plus durvalumab combination therapy as assessed by central pathology review
To evaluate the efficacy, measured by RCB, of olaparib monotherapy and olaparib plus durvalumab combination therapy as assessed by local pathology review
To evaluate the efficacy, measured by pCR (pathological complete response) rate, of olaparib monotherapy and olaparib plus durvalumab combination therapy, as assessed by central pathology review.
To evaluate the efficacy, measured by pCR rate, of olaparib monotherapy and olaparib plus durvalumab combination therapy as assessed by local pathology review
Month 15
Body Temperature
Pulse rate (heart rate)
Combined Modality Therapy
Safety and tolerability profile of olaparib monotherapy when given as adjuvant therapy to participants who achieve pCR by assessment of AEs/SAEs
Diastolic blood pressure
The number of participants with adverse events / serious adverse events of olaparib monotherapy when given as adjuvant therapy to participants who achieve pCR.
Combined Modality Therapy
Weight

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Cohort B
1 of 2
Cohort A
1 of 2

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Cohort B · No Placebo Group · Phase 2

Cohort B
CombinationProduct
Experimental Group · 1 Intervention: Neoadjuvant combination therapy with olaparib plus durvalumab · Intervention Types: CombinationProduct
Cohort A
Drug
Experimental Group · 1 Intervention: Neoadjuvant Olaparib monotherapy group · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approx. 3 years

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,960 Previous Clinical Trials
91,810,103 Total Patients Enrolled
158 Trials studying Breast Cancer
1,236,889 Patients Enrolled for Breast Cancer
Anitra Fielding, MBChBStudy DirectorAstraZeneca

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are female and of childbearing potential.
IHC 0, 1+ without in situ hybridization OR In situ hybridization non-amplified with ratio less than 2.0 OR In situ hybridization average HER2 copy number < 6 signals/cells.
You have a documented BRCA1 or BRCA2 mutation.
You have a performance status of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: November 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.