Trial Outcomes & Findings for Hepatic Artery Infusion With FOLFOX in Liver Metastasis From Breast Cancer (NCT NCT01937507)
NCT ID: NCT01937507
Last Updated: 2018-02-07
Results Overview
To determine response rate (RR) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
TERMINATED
PHASE2
2 participants
One year
2018-02-07
Participant Flow
Participant milestones
| Measure |
HAI With FOLFOX
Hepatic Artery Infusion with Oxaliplatin, 5FU, and Folinic Acid
HAI with FOLFOX: HAI with FOLFOX q 3 weeks
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hepatic Artery Infusion With FOLFOX in Liver Metastasis From Breast Cancer
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: One yearPopulation: Data was not collected
To determine response rate (RR) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: One yearPopulation: Data was not collected
To determine time to intra-hepatic progression (TIP) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: One yearPopulation: Data was not collected
To determine time to extra-hepatic progression (TEP) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one yearPopulation: Data was not collected
Document the toxicity and tolerability of the therapy using the following CBC with differential, BUN, creatinine, liver function tests,CA 15-3, CA 27.29, Circulating tumor cells (CTCs)and Restaging radiographic studies (MRI or CT liver protocol).
Outcome measures
Outcome data not reported
Adverse Events
HAI With FOLFOX
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place