Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer (ICEBERG 1)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Olaparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00494234

D0810C00008

KU36-44

2006-006458-91 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

This is a Phase II, open-label, non-comparative, international, multicenter study to assess the efficacy and safety of olaparib when given orally twice daily (bd) in participants with advanced BRCA1- or BRCA2- associated breast cancer. Two sequential participant cohorts will receive continuous oral olaparib in 28-day cycles. The first cohort will receive 400 mg bd and the second cohort will receive 100 mg bd.

Enrollment: 54 patients

Sex: Female

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced breast cancer with positive BRCA1 or BRCA2 status
• Failed at least one prior chemotherapy
• In investigators opinion, no curative standard therapy exists
• Measurable disease

Exclusion criteria

• Brain metastases
• Less than 28 days since last treatment used to treat the disease
• Considered a poor medical risk due to a serious uncontrolled disorder

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

54 participants in 2 patient groups

Olaparib 100 mg

Experimental group

Description:

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.

Treatment:

Drug: Olaparib

Olaparib 400 mg

Experimental group

Description:

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.

Treatment:

Drug: Olaparib