Women with newly diagnosed breast cancer who are expected to receive neo-adjuvant or adjuvant therapy. MedDRA version: 20.0 Level: LLT Classification code 10006188 Term: Breast cancer female NOS System Organ Class: 100000020806
Conditions
Interventions
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
INN or Proposed INN: CYCLOPHOSPHAMIDE
CAS Number: 50-
Sponsors
Dept. of Oncology, Karolinska university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Up to 10 years after treatment.;Secondary end point(s): 1. Time-to-development of clinical or subclinical cardiotoxicity 2. Severity of clinical or subclinical cardiotoxicity, over time. 3. Identification of patients with clinical or subclinical cardiotoxicity up to 10 years after treatment as assessed by: Serum concentrations of study specific biomarkers (See Appendix C) Tissue Doppler and strain echocardiographic variables (See chapter 1.4.3) Electrocardiographic variables (See Appendix C) 4. Patient Reported Outcome endpoints including health related questionnaires (Minnesota Living with Heart Failure, Patient Health Questionnaire, the Hospital Anxiety Depression Scale, Multidimensional Fatigue Inventory, and cancer specific questionnaires from the European Organisation for Research and Treatment of Cancer) | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the cumulative incidence of cardiotoxic events in female breast cancer patients within and between two groups: Standard oncological follow-up and care vs. Standard oncological follow-up and care + subclinical cardiotoxicity surveillance and treatment, before start of chemotherapy, during treatment and at 1, 5, and 10 years after the completion of chemotherapy.;Secondary Objective: • To assess the association between standard cardiac risk factors, biomarkers and parameters of echocardiography, electrocardiography, and cardiac magnetic resonance imaging, (predictors) and subsequent occurrence of clinical or subclinical cardiotoxicity (outcome) within and between-groups, over time • To determine how a diagnosis of breast cancer and the development of cardiotoxicity influences women’s quality of life.;Primary end point(s): Frequency of clinical or subclinical cardiotoxicity as assessed by Echocardography or ECG, over time. Clinical and subclinical cardiotoxicity will be defined by cardiologist at routine practice using the current guidelines and protocol.;Timepoint(s) of evaluation of this end point: 1 year, 5 years and 10 years after treatment. | — |
Countries
Sweden
Contacts
Public ContactBreast-sarcoma unit
Dept. of Oncology, Karolinska university hospital
Outcome results
None listed