Metastatic Breast Cancer Clinical Trial
Official title:
An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination With Capecitabine for Progressive or Recurrent Metastatic Breast Cancer
The purpose of this study is to determine the recommended phase 2 dose and overall safety and tolerability of TRC105 when given in combination with capecitabine for the treatment of patients with progressive or recurrent metastatic breast cancer.
All patients were required to sign a consent form prior to undertaking any study-related
procedures. Prospective patients were screened to determine if they qualified for the study
within 28 days of enrollment. Patients who qualified received TRC105 i.v. over 1 to 4 hours
on Day 1, Day 4, Day 8 and Day 15 of the initial 21-day cycle and Day 1, Day 8 and Day 15 of
every subsequent 21-day cycle in combination with 1000 mg/m2 capecitabine BID for 14 days of
each 21-day cycle. Those who tolerated TRC105 without any infusion reactions were eligible
for reduced infusion durations. After 3 cycles of treatment, patients who demonstrated a
response of complete response (CR), partial response (PR) or stable disease (SD) were
eligible for additional treatment for up to six months (9 total cycles). Upon discussion with
TRACON, patients judged by the Principal Investigator to be benefiting from treatment were
able to continue treatment on this protocol beyond six months.
Toxicities were graded according to the NCI CTCAE Version 4.0. Patients who exited the study
for reasons other than drug-related toxicity prior to completion of the first 21-day cycle
were replaced. Intra-patient dose escalation was not allowed.
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