SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer

Summary

Open label multicentric phase II randomized trial, using high throughput genome analysis as a therapeutic decision tool, which aims at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with maintenance chemotherapy (targeted substudy 1) as well as immunotherapy with maintenance chemotherapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).

Conditions

• Metastatic Breast Cancer

Interventions

DRUG

AZD2014

Target: m-TOR

DRUG

AZD4547

Target: EGFR

DRUG

AZD5363

Target: AKT

DRUG

AZD8931

Target: HER2, EGFR

DRUG

Selumetinib

Target: MEK

DRUG

Vandetanib

Target: VEGF, EGFR

DRUG

Bicalutamide

target: Androgen receptor

DRUG

Olaparib

Target: PARP

DRUG

Anthracyclines

DNA intercalation

DRUG

Taxanes

Target: mitotic tubulin and microtubules

DRUG

cyclophosphamide

Alkylating agents

DRUG

DNA intercalators

DNA intercalators

DRUG

Methotrexate

DNA intercalators

DRUG

vinca alkaloids

Target: mitotic tubulin and microtubules

DRUG

Platinum based chemotherapies

Platinum based chemotherapies

DRUG

Bevacizumab

Target: VEGF

DRUG

Mitomycin C

Alkylating agents

DRUG

Eribulin

Microtubule modulator

DRUG

MEDI4736

Target: PD-L1

Sponsors & Collaborators

• Fondation ARC

  collaborator OTHER

• AstraZeneca

  collaborator INDUSTRY

• UNICANCER

  lead OTHER

Principal Investigators

• Fabrice ANDRE, Pr · Gustave Roussy, Villejuif

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-07

Primary Completion

2022-12-31

Completion

2025-12-31

Countries

• France

Study Locations