Identifying early side effects in the heart without symptoms in patients with breast cancer treated with chemotherapy.

Phase 1

• Conditions: Women with newly diagnosed breast cancer who are expected to receive neo-adjuvant or adjuvant therapy.; MedDRA version: 20.0Level: LLTClassification code 10006188Term: Breast cancer female NOSSystem Organ Class: 100000020806; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001467-20-SE
• Lead Sponsor: Dept. of Oncology, Karolinska university hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-22
• Last Update Posted: 16 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Women with newly diagnosed breast cancer who are eligible to receive neo-adjuvant or adjuvant chemotherapy, with or without trastuzumab, according to the guidelines for breast cancer.
• Written informed consent must be given.
• The participants can be included in other non-competing ongoing trilas.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

• A history of heart disease; ischemic heart disease, arrhythmias, heart failure, and valve diseases.
• Previously received oncological treatment for any malignancy.
• Other disease or conditions that complicates or precludes the patient from following the study protocol.
• Patients in child-bearing age without adequate contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified