Overview

"Curcumin" in Combination With Chemotherapy in Advanced Breast Cancer

Status:
Completed
Trial end date:
2019-06-30
Target enrollment:
0
Participant gender:
Female
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)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Center of Oncology, Armenia
Collaborator:
BRIU GmbH
Treatments:
Albumin-Bound Paclitaxel
Curcumin
Paclitaxel
Pharmaceutical Solutions
Criteria
INCLUSION CRITERIA:

- Patients must fulfill all the following criteria to be eligible for this study.

- Patient should be able to give fully informed written consent according to
International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP)
guidelines and to comply with the instructions in the protocol.

- Patients should be diagnosed with histologically-proven breast carcinoma.

- Female subjects 18 years or older.

- Radiographic evidence of measurable disease is required and must have been performed
within 8 weeks prior to randomization. Acceptable studies include plain radiographs,
ultrasound imaging, computed tomography scans and magnetic resonance imaging. Other
studies may be acceptable with the approval of the principal investigator.

- Bidimensionally measurable manifestations of progressive advanced disease after one
prior chemotherapy regimen, or locally advanced or MBC that progressed during or
within 12 months of completing an adjuvant or neoadjuvant chemotherapy regimen or
other cases of breast cancer in which weekly paclitaxel treatment is considered an
adequate approach.

- No Herceptin treatment 4 weeks before and during the study.

- No other chemotherapy and bisphosphonate therapy 4 weeks before random assignment and
during the study. Prior and concomitant hormonal therapy is allowed.

- Karnofsky performance score (KPS) ≥60, ECOG≤2.

- Life expectancy 3 month or greater, as estimated by the responsible clinician.

- Women of child-bearing age must use effective contraception.

- Sufficient hematological status. Adequate bone marrow function defined as:

- WBC greater than 4.0 x 10^9/L

- Granulocyte count greater than 1.5 x 10^9/L

- Platelet count greater than 100 x 10^9/L

- Haemoglobin greater than 10 g/dl;

- Adequate renal function: calculated creatinine clearance (Cockcroft-Gault formula)
greater than 45 ml/min;

- Adequate hepatic function defined as a total bilirubin less than Upper Limit of Normal
(ULN), Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) less than
2.5 x ULN, or 1.5 x ULN if Alkaline Phosphatase (Alk Phos) less than 2.5 x ULN. Alk
Phos less than 5 x ULN unless patient has bone metastases;

EXCLUSION CRITERIA:

- inadequate renal and hepatic functions;

- inadequate haematological status;

- uncontrolled central nervous system metastases;

- severe cardiovascular disorders;

- active infection;

- Psychiatric or addictive disorders or other conditions that, in the opinion of the
investigator, would preclude the patient from meeting the study requirements;

- Other non-malignant systemic and/or other disease, that would preclude the patient
from receiving study treatment or would prevent required follow-up (at the discretion
of the principal investigator);

- Known hypersensitivity to any of the study drugs or excipients;

- Pregnancy or lactation;

- Second primary malignancy diagnosed within the last 5 years (except for adequately
treated non-melanoma skin cancers and in-situ cervical carcinoma adequately treated by
cone excision);

- Herceptin and/or chemotherapy and/or bisphosphonate therapy less than 4 weeks before
the randomisation;