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

Sponsor
UNICANCER
Study ID
NCT02299999
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD2014 — DRUG
    Target: m-TOR
  • AZD4547 — DRUG
    Target: EGFR
  • AZD5363 — DRUG
    Target: AKT
  • AZD8931 — DRUG
    Target: HER2, EGFR
  • Selumetinib — DRUG
    Target: MEK
  • Vandetanib — DRUG
    Target: VEGF, EGFR
  • Bicalutamide — DRUG
    target: Androgen receptor
  • Olaparib — DRUG
    Target: PARP
  • Anthracyclines — DRUG
    DNA intercalation
  • Taxanes — DRUG
    Target: mitotic tubulin and microtubules
  • cyclophosphamide — DRUG
    Alkylating agents
  • DNA intercalators — DRUG
    DNA intercalators
  • Methotrexate — DRUG
    DNA intercalators
  • vinca alkaloids — DRUG
    Target: mitotic tubulin and microtubules
  • Platinum based chemotherapies — DRUG
    Platinum based chemotherapies
  • Bevacizumab — DRUG
    Target: VEGF
  • Mitomycin C — DRUG
    Alkylating agents
  • Eribulin — DRUG
    Microtubule modulator
  • MEDI4736 — DRUG
    Target: PD-L1

Study Details

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).

Key Dates

Start date
Apr 7, 2014
Status verified
Jan 2025
Primary completion
Dec 31, 2022
Completion
Dec 31, 2025

Study Design

Enrollment
1,460 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy 1: targeted agent
    Arm A1 / Targeted Arm : targeted maintenance from a list of 8 targeted drugs guided by the genomic analysis, AZD2014 tablet per os 50 mg bd, continuous dosing, AZD4547 tablet per os 80 mg bd, 2 weeks on/1 week off, AZD5363 capsule per os 480 mg bd, 4 days on/3 days off, AZD8931 tablet per os 40 mg bd, continuous dosing, selumetinib capsule per os 75 mg bd, continuous dosing, vandetanib tablet per os 300 mg od, continuous dosing, bicalutamide tablet per os 150 od, continuous dosing, olaparib tablet per os 300 mg bd, continuous dosing
  • Active Comparator: Substudy 1: standard maintenance therapy
    Arm B1/ maintenance Standard Chemotherapy Arm : such as Anthracyclines (Doxorubicin or Epirubicin or Liposomal Doxorubicine), Taxanes (Paclitaxel, Docetaxel), Cyclophosphamide, DNA Intercalators (Capecitabine, 5-FU, gemcitabine), Methotrexate, Vinca alkaloids (Vinorelbine, Vinblastine, Vincristine), Platinum based chemotherapies (Carboplatin, Cisplatin), Bevacizumab, Mitomycin C, Eribulin
  • Experimental: Substudy 2: Immunotherapy
    Arm A2/ Immunotherapy arm: maintenance with MEDI4736 for patient without actionable genomic alterations or non eligible to Targeted substudy 1, MEDI4736 Intra-venous 10 mg/kg, Q2W
  • Active Comparator: Substudy 2: standard maintenance therapy
    Arm B2/ maintenance Standard Chemotherapy Arm : such as Anthracyclines (Doxorubicin or Epirubicin or Liposomal Doxorubicine), Taxanes (Paclitaxel, Docetaxel), Cyclophosphamide, DNA Intercalators (Capecitabine, 5-FU, gemcitabine), Methotrexate, Vinca alkaloids (Vinorelbine, Vinblastine, Vincristine), Platinum based chemotherapies (Carboplatin, Cisplatin), Bevacizumab, Mitomycin C, Eribulin

Primary Outcome Measure

Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm [ Time Frame: from randomization to disease progression or death from any cause, whichever comes first, up to 16 months (estimated treatment duration average: 4 months) ]

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