West Cancer Center

BREAST: Metastatic: HER2 negative: 1st-3rd line: "D081EC00001"

A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety, Tolerability and Efficacy of Olaparib in Combination With Carboplatin: Part A: Dose Escalation of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer; Followed by Part B: an Expansion Phase of Olaparib in Combination With Carboplatin in the Neoadjuvant Treatment of HER-2 Negative Breast Cancer Patients With Germline BRCA1/2 Mutations

Title

Astra Zeneca D081EC00001

Study Title

Site Link

NCT02561832

Malignancy

Breast, Metastatic HER2 negative breast cancer,

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st, 2nd, or 3rd

Investigational Agent

olaparib

Drug Class

PARP inhibitor

Greg Vidal, MD, PhD

Sponsor

AstraZeneca

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

NCT02561832

Key Eligibility Criteria Details

Advanced or metasatic HER2- breast cancer
Between 0-2 lines of prior chemotherapy
Neoadj or adjuvant therapy counts as a line of therapy if given within 12 months of development of metastatic disease
CNS disease allowed if >12 weeks after treatment and patient is off steroids
No prior platinum in metastatic setting
No known HBV, HCV, or HIV

Objective

Primary- Safety and Tolerability, Secondary- ORR, TTF, PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

HER2 neg. HR+ or HR-

Dosing Frequency

Control Agents

Study Protocol

Randomized