NCT02624700 - 2nd Line Treatment With Pemetrexed and Sorafenib for Recurrent or Metastatic Triple Negative Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 28, 2016

Primary Completion Date

July 10, 2019

Study Completion Date

July 10, 2019

Conditions

Breast CancerMetastatic Breast CancerRecurrent Breast Cancer

Interventions

DRUG

Experimental Arm A: Pemetrexed

Treatment schedule is administered on day 1 of each 14-day cycle by Intravenous infusion over 10 minutes with a dose of 500 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.

DRUG

Experimental Arm A: Sorafenib

Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 14-day cycle with a dose of 400 mg.

DRUG

Experimental Arm B: Pemetrexed

Treatment schedule is administered on day 1 of each 21-day cycle by Intravenous infusion over 10 minutes with a dose of 375 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.

DRUG

Experimental Arm B: Sorafenib

Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 21-day cycle with a dose of 200 mg.

Trial Locations (1)

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond