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A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer

NCT02561832 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-02-20

Study results available
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Summary

This is an open-label study to assess the safety, tolerability and efficacy of olaparib in combination with carboplatin. There are two parts in this study: Part A, a dose escalation in patients with advanced Human Epidermal Growth Factor 2 (HER-2) negative breast cancer and Part B, a dose expansion in the neoadjuvant treatment of HER-2 negative breast cancer patients with germline Breast Cancer Susceptibility Gene (BRCA)1/2 mutations.

Conditions

Interventions

DRUG

Olaparib

tablets taken orally twice daily

DRUG

Carboplatin

intravenous injections on day one of each cycle

DRUG

Anthracycline

The choice of anthracycline and cyclophosphamide (AC) regimen in Part B will be up to local Investigator following international guidelines

DRUG

Cyclophosphamide

The choice of anthracycline and cyclophosphamide (AC) regimen in Part B will be up to local Investigator following international guidelines

Sponsors & Collaborators

Principal Investigators

  • Judith Balmana · Hospital Vall d'Hebron, Barcelona, Spain

  • Tiffany Traina · Memorial Sloan Kettering Cancer Center, New York, USA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-06
Primary Completion
2016-09-30
Completion
2017-02-01

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02561832 on ClinicalTrials.gov