Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer

(ICEBERG 1 Trial)

Recruiting in Palo Alto (17 mi)

+25 other locations

Overseen by Andrew Tutt, PhD MRCP FRCR

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well tolerated in treating participants with measurable breast cancer gene (BRCA)1- or BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.

Research Team

Andrew Tutt, PhD MRCP FRCR

Principal Investigator

Guy's and St Thomas's NHS Foundation Trust, London, UK

James Carmichael, BSc, MBChB, MD, FRCP

Principal Investigator

KuDOS Pharmaceuticals Limited

Eligibility Criteria

Inclusion Criteria

In investigators opinion, no curative standard therapy exists

Measurable disease

Advanced breast cancer with positive BRCA1 or BRCA2 status

Treatment Details

Interventions

• KU-0059436 (AZD2281) (PARP Inhibitor)

Participant Groups

Group I: Olaparib 400 mg Experimental Treatment 1 Intervention

Participants will receive eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion is met.

Group II: Olaparib 100 mg Experimental Treatment 1 Intervention

Participants will receive two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion is met.

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

KuDOS Pharmaceuticals Limited

Industry Sponsor

Trials

5

Recruited

210+