"Curcumin" in Combination With Chemotherapy in Advanced Breast Cancer

NCT03072992 | Completed Phase 2 DMC

• 1 other identifier: 5592-17-02-23
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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)

Conditions

Advanced Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Objective response rate, assessed with the Modified Response Evaluation Criteria In Solid Tumours (RECIST).

  4 weeks after the completion of the treatment

Secondary Outcomes (5)

• Adverse events

  24 weeks

• Global Health Status/QoL scale

  24 weeks

• Progression free survival

  24 weeks

• Time to Treatment Failure

  24 weeks

• Time to Tumour Progression

  24 weeks

Study Arms (2)

Group A: Paclitaxel & Curcumin

ACTIVE COMPARATOR

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; Drug: Paclitaxel

Group B: Paclitaxel & Placebo

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

Curcumin DRUG

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

Also known as: CUC-01

Group A: Paclitaxel & Curcumin

Paclitaxel DRUG

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

Group A: Paclitaxel & Curcumin; Group B: Paclitaxel & Placebo

Placebo DRUG

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

Group B: Paclitaxel & Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• National Center of Oncology, Armenia: lead
• BRIU GmbH: collaborator

Study Sites (1)

National Center of Oncology

Yerevan, 0052, Armenia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Curcumin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Armen Tananyan, PhD

  National Center of Oncology, Armenia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 8, 2017
• Study Start: March 20, 2017
• Primary Completion: November 20, 2018
• Study Completion: June 30, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

AR (1)