ClinicalTrials.gov
ClinicalTrials.gov Menu

"Curcumin" in Combination With Chemotherapy in Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03072992
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
BRIU GmbH
Information provided by (Responsible Party):
National Center of Oncology, Armenia

Brief 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)

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Metastatic Breast Cancer Drug: Curcumin Drug: Paclitaxel Drug: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: Study of Efficacy of Curcumin in Combination With Chemotherapy in Patients With Advanced Breast Cancer: Randomized, Double Blind, Placebo Controlled Clinical Trial
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Group A: Paclitaxel & Curcumin
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.
Drug: Curcumin
Curcumin (CUC-01), 300mg i.v. , once weekly for 12 weeks.
Other Name: CUC-01

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

Placebo Comparator: Group B: Paclitaxel & Placebo
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.
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




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 4 weeks after the completion of the treatment ]
    Objective response rate, assessed with the Modified Response Evaluation Criteria In Solid Tumours (RECIST).


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 24 weeks ]
    Adverse events and defined by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0 (CTCAE, v4.0≤).

  2. Global Health Status/QoL scale [ Time Frame: 24 weeks ]
    Health status measured by Global Health Status/QoL scale of EORTC QLQ-C30.

  3. Progression free survival [ Time Frame: 24 weeks ]
    Progression free survival assessed from study enrolment to tumour progression as per the Modified RECIST criteria.

  4. Time to Treatment Failure [ Time Frame: 24 weeks ]
    Time to Treatment Failure assessed from study enrolment to cessation of study treatment for any reason.

  5. Time to Tumour Progression [ Time Frame: 24 weeks ]
    Time to Tumour Progression assessed from study enrolment to tumour progression as per the Modified RECIST criteria.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072992


Contacts
Contact: Tatul Saghatelyan, PhD +374 91 421928 saghatelyan@armtelemed.org

Locations
Armenia
National Center of Oncology Recruiting
Yerevan, Armenia, 0052
Contact: Tatul Saghatelyan, PhD    +374 91 421928    saghatelyan@armtelemed.org   
Principal Investigator: Tatul Saghatelyan, PhD         
Sub-Investigator: Hasmik Petrosyan, MD         
Sub-Investigator: Mher Kostanyan, PhD         
Sub-Investigator: Anna Tadevosyan, PhD         
Sub-Investigator: Naira Janoyan, PhD         
Sub-Investigator: Araxya Hovhannisyan, MD         
Sponsors and Collaborators
National Center of Oncology, Armenia
BRIU GmbH
Investigators
Study Chair: Armen Tananyan, PhD National Center of Oncology, Armenia

Responsible Party: National Center of Oncology, Armenia
ClinicalTrials.gov Identifier: NCT03072992     History of Changes
Other Study ID Numbers: 5592-17-02-23
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pharmaceutical Solutions
Paclitaxel
Albumin-Bound Paclitaxel
Curcumin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Enzyme Inhibitors