A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
Hoffmann-La Roche
Study ID
NCT03371017
Phase
PHASE3
Status
Completed

Conditions

  • Triple Negative Breast Neoplasms

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered, 1200 mg by IV infusion with : gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle
  • Placebo — DRUG
    Placebo will be administered, 1200 mg by IV infusion with : gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle
  • Capecitabine — DRUG
    Capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle
  • Carboplatin — DRUG
    Carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle

Study Details

This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

Key Dates

Start date
Jan 11, 2018
Status verified
Oct 2025
Primary completion
Oct 23, 2024
Completion
Oct 23, 2024

Study Design

Enrollment
595 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab
    Participants will receive Atezolizumab on day 1 of each 3-week treatment cycle
  • Placebo Comparator: Placebo
    Participants will receive Placebo on day 1 of each 3-week treatment cycle

Primary Outcome Measure

Overall Survival (OS) in PD-L1-positive Population [ Time Frame: Time from randomization to death (Up to 68 months) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Florida Cancer Specialists - Fort Myers (Broadway)Fort MyersFlorida33916-
Florida Cancer Specialists & Research InstituteSt. PetersburgFlorida33705-
The Valley HospitalParamusNew Jersey07652-
Magee-Woman's HospitalPittsburghPennsylvania15213-
SCRI Oncology PartnersNashvilleTennessee37203-
Inova Schar Cancer InstituteFairfaxVirginia22031-

Related coverage on Hipa.ai

Find similar trials in Fort Myers, FL

By research site
Florida Cancer Specialists - Fort Myers (Broadway)· Fort Myers, FLFlorida Cancer Specialists & Research Institute· St. Petersburg, FLThe Valley Hospital· Paramus, NJMagee-Woman's Hospital· Pittsburgh, PASCRI Oncology Partners· Nashville, TNInova Schar Cancer Institute· Fairfax, VA

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