MedTrace Logo

"Curcumin" in Combination With Chemotherapy in Advanced Breast Cancer

NCT03072992 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-11-27

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Curcumin

Curcumin (CUC-01), 300mg i.v. , once weekly for 12 weeks.

DRUG

Paclitaxel

Paclitaxel (colorless solution) 80 mg /m2 BS, i.v., once weekly for 12 weeks.

DRUG

Placebo

Placebo i.v. solution, once weekly for 12 weeks

Sponsors & Collaborators

  • BRIU GmbH

    collaborator UNKNOWN

  • National Center of Oncology, Armenia

    lead OTHER

Principal Investigators

  • Armen Tananyan, PhD · National Center of Oncology, Armenia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2018-11-20
Completion
2019-06-30

Countries

  • Armenia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03072992 on ClinicalTrials.gov