"Curcumin" in Combination With Chemotherapy in Advanced Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03072992
• Date of registration: 28/02/2017
• Prospective Registration: Yes
• Primary sponsor: National Center of Oncology, Armenia
• Public title: "Curcumin" in Combination With Chemotherapy in Advanced Breast Cancer
• Scientific title: Study of Efficacy of Curcumin in Combination With Chemotherapy in Patients With Advanced Breast Cancer: Randomized, Double Blind, Placebo Controlled Clinical Trial
• Date of first enrolment: March 20, 2017
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03072992
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Armenia

Contacts

• Name: Armen Tananyan, PhD
• Affiliation: National Center of Oncology, Armenia

Key inclusion & exclusion 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;



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Advanced Breast Cancer

Intervention(s)

Drug: Paclitaxel

Drug: Curcumin

Drug: Placebo

Primary Outcome(s)

Objective response rate [Time Frame: 4 weeks after the completion of the treatment]

Secondary Outcome(s)

Adverse events [Time Frame: 24 weeks]

Time to Tumour Progression [Time Frame: 24 weeks]

Progression free survival [Time Frame: 24 weeks]

Time to Treatment Failure [Time Frame: 24 weeks]

Global Health Status/QoL scale [Time Frame: 24 weeks]

Secondary ID(s)

5592-17-02-23

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

BRIU GmbH