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A Study of Cannabidiol, Resveratrol Copper, and Perioperative Treatments in Patients Receiving Pre-Surgery Treatment for Breast Cancer

Impact of Cannabidiol, Resveratrol Copper and perioperative Interventions in the Outcomes of Breast Cancer patients undergoing Neo-adjuvant Systemic Therapy - ICCONIC study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/111935
Enrollment
1440
Registered
2026-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Cannabidiol (CBD) 300 mg/day: Cannabidiol (CBD) 300 mg/day orally (divided doses) till surgery Intervention2: Resveratrol Copper (R-Cu): Resveratrol Copper (R-Cu) orally up to 1 month p

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proved breast carcinoma 2. All LABC/LOBC patients undergoing Neoadjuvant systemic Therapy. 3.From 18 years to 65 years 4. Written informed consent 5. ECOG-1 6. Fit for surgery or chemotherapy

Exclusion criteria

Exclusion criteria: 1.Pregnant, Lactating women 2. Previous h/o breast or any other non-skin malignancy 3. Previous history of excision biopsy/other cancer. 4. Drug Addication/present substance abuse 5. History of allergy to Inj. Lignocaine

Design outcomes

Primary

MeasureTime frame
Primary endpoint- 1.Event free survival Timepoint: 7 years

Secondary

MeasureTime frame
Secondary endpoint- 1. Overall survival- key secondary endpoint 2. Estimated pCR rates at interim analysis. 3. Evaluation of ctDNA levels 4. Evaluation of incidenence of CINV in both the arms Timepoint: 7 years

Countries

India

Contacts

Public ContactShabina Siddique

ACTREC

dileep.hoysal@actrec.gov.in9901829377

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026