Assessing the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency

PHASE2CompletedINTERVENTIONAL
Enrollment

107

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

February 28, 2019

Study Completion Date

February 29, 2020

Conditions
Breast CancerTriple Negative Breast NeoplasmsHRpos Breast NeoplasmsBRCA 1 /2 and / or HRD
Interventions
DRUG

PwO

paclitaxel 80 mg/m² iv weekly in combination with olaparib tablets 100 mg twice daily for 12 weeks (PwO) (65 patients)

DRUG

PwCb

paclitaxel 80 mg/m² iv weekly in combination with carboplatin AUC 2 iv weekly for 12 weeks (PwCb) (37 patients)

DRUG

EC

both Arms followed by 4 cycles of epirubicin 90 mg/m² and cyclophosphamide 600 mg/m² (EC) either every 3 or every 2 weeks followed by surgery.

PROCEDURE

Surgery after neoadjuvant Therapy

In both study arms, treatment will be given until surgery, disease progression, unacceptable toxicity, or withdrawal of consent of the patients.

OTHER

Stratification

Hormone-receptor status (HR+ vs HR-) Age \< 40 years vs \>= 40 years

Trial Locations (12)

10367

Praxisklinik, Berlin

18059

Klinikum Südstadt, Rostock

31134

Gemeinschaftspraxis, Hildesheim

31785

Sana Klinikum Hameln-Pyrmont, Hamelin

34117

Elisabeth Krankenhaus, Kassel

39576

Johanniter-Krankenhaus Genthin-Stendal, Stendal

58452

Marienhospital Witten, Witten

73730

Kliniken Esslingen, Gynäkologie Onkologie, Esslingen am Neckar

80638

Onkologisches Zentrum am Rotkreuzklinikum München, München

91054

Universitätsklinikum Erlangen, Erlangen

06120

Martin-Luther-Universität Halle Wittenberg, Halle

07548

SRH Wald-Klinikum Gera GmbH, Gera

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

GBG Forschungs GmbH

OTHER