Neoadjuvant Chemotherapy Docetaxel With or Without SELUMETINIB in Patients With Triple Negative Breast Cancer

Sponsor
Russian Academy of Medical Sciences
Study ID
NCT02685657
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Drug: Selumetinib — DRUG
  • Doxorubicin — DRUG
  • Cyclophosphamide — DRUG
  • Docetaxel — DRUG

Study Details

The purpose of this study is to increase survival of patients with early and locally advanced triple-negative breast cancer adding selumatinib to standard preoperative chemotherapy regimen.

Key Dates

Start date
Sep 30, 2016
Status verified
Feb 2016
Primary completion
Jan 31, 2018

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AC followed by Docetaxel with Selumetinib
    Doxorubicin 60 mg/m2 and Cyclophosphamide 600 mg/m2 as a single IV infusion on day 1 of every 3 week cycle then 75 mg/m2 of Docetaxel given as a single IV infusion on day 1 of every 3 week cycle, 75 mg of SELUMETINIB twice a day PO on days 1-21 of every 3 week cycle
  • Active Comparator: AC followed by Docetaxel
    Doxorubicin 60 mg/m2 and Cyclophosphamide 600 mg/m2 as a single IV infusion on day 1 of every 3 week cycle then 75 mg/m2 of Docetaxel given as a single IV infusion on day 1 of every 3 week cycle

Primary Outcome Measure

• Pathological complete response rate [ Time Frame: After 24 weeks of neoadjuvant chemotherapy and surgery ]

Central Contacts

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