"Curcumin" in Combination With Chemotherapy in Advanced Breast Cancer
Status:
Completed
Trial end date:
2019-06-30
Target enrollment:
Participant gender:
Summary
The aim of this study is to assess benefits of treatment with intravenous Curcumin® (CUC-01)
vs placebo, in combination with paclitaxel chemotherapy, and to estimate the risk of adverse
events in patients with locally advanced and metastatic breast cancer.
This is a randomized, double-blind, placebo-controlled, two arms parallel group phase 2
clinical trial:
Group A, 75 patients, treatment with Curcumin (CUC-01, yellow solution), 300mg i.v. plus i.v.
Paclitaxel (colorless solution) 80 mg /m2 BS i.e., once weekly for 12 weeks.
Group B, 75 patients, treatment with Paclitaxel (colorless solution) 80 mg /m2 BS, i.v. plus
placebo i.v. solution (250 ml, yellow solution for masking/blinding), once weekly for 12
weeks.
Primary objective of the study:
To assess:
- Efficacy of combined therapy with Curcumin ®, (CUC-01) and Paclitaxel vs Paclitaxel in
patients with advanced and metastatic breast cancer in terms of Objective Response Rate
(ORR) assessed with the Modified Response Evaluation Criteria In Solid Tumours (RECIST).
Secondary objectives of the study:
To assess:
- The safety of Curcumin+Paclitaxel combination compared to Paclitaxel+placebo treatment
by assessment of adverse effects.
- Quality of life (QOL) in patient treated with Curcumin+Paclitaxel combination compared
to Paclitaxel+Placebo
- Response duration in terms of Progression free survival (PFS), Time to Disease
Progression (TTP) and Time to treatment failure (TTTF)