Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial.

Plain-language summary

This study evaluated the preoperative use of Tocotrienol in patients with operable breast cancer. Patients with histologically confirmed operable primary breast cancer (T1-T2 N0-1 M0) and no distant metastasis were eligible. The study was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Intervention

Tocotrienol

Start date

2/9/2016

Estimated completion

7/6/2017

Countries

Italy

Related genes

Locations

• Milan, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* histologically confirmed operable primary breast cancer (T1-T2 N0-1 M0)
* absence of distant metastasis
* signed informed consent.

Exclusion Criteria:

* Previous malignancies other than in situ cervical carcinoma or nonmelanoma skin cancer
* Breast cancer recurrence
* Metastatic breast cancer
* Non-epithelial breast cancer at histological examination
* In situ lobular breast cancer
* Participation in other randomized clinical trials that could interfere with current study
* Living distant from center and unable to attend for check-ups and meetings