Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT02909751
Eligibility Criteria:
Inclusion Criteria:
* Women with histologically verified breast cancer (adenocarcinoma)
* Age ≥ 18 years.
* Neoadjuvant treatment indicated according to departmental guidelines
* PS 0-2 and suited for surgery.
* Normal heart function, LVEF ≥ 50% by MUGA/ECHO in patients receiving neoadjuvant trastuzumab
* Normal bone marrow function: Hemoglobin ≥ 6 mmol/l; ANC ≥ 1.5x10\^9/l; Thrombocytes ≥ 100x10\^9/l.
* Normal liver function: Bilirubin ≤ 1.5 x upper level of normal, ALAT ≤ 2.5 x upper level of normal, BASP ≤ 2.5 x upper level of normal.
* Normal kidney function: Creatinine ≤ upper level of normal. In case of increased creatinine, measured/calculated GFR must be ≥ 50 ml/min.
* Fertile women must present a negative pregnancy test and use a safe contraceptive during and 3 months after the treatment. Intrauterine device without hormone is considered safe.
* Written and orally informed consent
Exclusion Criteria:
* Bilateral breast cancer or suspected dissemination. Verified by bilateral mammography, bone scintigraphy, chest and abdomen CT, and PET-CT.
* Pregnant and breastfeeding women
* Mental or social conditions that will prevent treatment or follow-up
* Other simultaneous experimental treatment
* Immunosuppressive treatment (other than prednisolone during neoadjuvant chemotherapy)
* Vitamin or nutritional supplements (other than multivitamin tablet and calcium tablet with vitamin D)
* Active or latent viral/bacterial infection
* Rheumatoid arthritis or other autoimmune disease
* Other malignant disease within the past 5 years excl. non-melanoma cancer of the skin and carcinoma in situ cervicis uteri.
* Previous treatment with docetaxel, paclitaxel, epirubicin, cyclophosphamide, trastuzumab, pertuzumab or tocotrienol
* Hypersensitivity to any of the active or auxiliary substances
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02909751
Study Brief:
Protocol Section:
NCT02909751