Breast cancer
Conditions
Interventions
Experimental Group (Group A): Will receive the standard treatment for their stage and clinical characteristics of cancer, indicated by their treating physicians, without the researchers intervening in
Sponsors
Medical School of the University of Colima, Mexico
State Institute of Cancerology of IMSS-BIENESTAR Colima, Mexico.
Eligibility
Sex/Gender
Female
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Clinical and histological diagnosis of stage III-IV breast cancer (according to the American Society of Clinical Oncology, ASCO) classification. 2. Recently diagnosed breast cancer (within 6 months) and without previous treatment, or in disease recurrence after having been only in follow-up and without treatment (without chemo/radiotherapy) for at least one year. 3. Histology of adenocarcinoma, with any positivity to estrogen, progestin or her2neu receptors. 4. ECOG 0-2. 5. Platelets = 100,000mm3. 6. Total serum bilirubin =1.5mg/dl.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of a primary cancer other than breast cancer. 2. Alcoholism and/or drug addiction. 3. Allergy to soursop. 4. Gastrointestinal ulcer. 5. Inflammatory bowel disease. 6. Diagnosis of ischemic heart disease. 7. Liver disease. 8. Kidney disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (Percentage of patients who achieve a Complete Response, defined as the disappearance of clinical and radiological evidence of the disease according to RECIST 1.1 criteria). Measurement time: 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events (According to the Common terminology criteria for adverse events (CTCAE) version 5). Measurement time: every week until month 6. 2. Quality of life (Questionnaires EORTC QLQ-C30 and EORTC QLQ-BR23). Measurement time: At baseline and, at 6 months of treatment. | — |
Countries
Mexico
Contacts
Public ContactIvan Delgado Enciso
State Institute of Cancerology of IMSS-BIENESTAR Colima, Mexico
Outcome results
None listed