Breast cancer.
Conditions
Interventions
Patients who are eligible to participate in the study will be enrolled in the study after a full explanation of the clinical trial process and written informed consent is obtained. The chemotherapy re
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1- Written consent to participate in the study 2- Female over 18 years of age at the time of study entry 3- Triple-negative breast cancer based on the pathology report of the biopsy of the breast mass 4- Absence of metastasis in radiological evaluations 5- Not receiving immunotherapy 6- Primary tumor status T1c-T4d 7- Lymph node involvement N0-N2 ECOG 0-1 9- Proper functioning of internal organs 10- LVEF greater than 50% on echocardiography 11- Negative HCG test within 72 hours before the start of pregnancy and consent to use contraceptive methods for up to 1 year after the end of chemotherapy.
Exclusion criteria
Exclusion criteria: 1- History of cancer in the past 5 years except basal or squamous cell skin cancer or cervical cancer in situ 2- Receiving chemotherapy, radiotherapy or immunotherapy in the past 1 year 3- Active infection requiring systemic treatment 4- HIV, hepatitis B, hepatitis C or active TB 5- Serious cardiovascular disease such as myocardial infarction or angioplasty in the past 6 months or CHF NYHA class II-IV 6- History of DVT or PTE 7- Known thrombophilia 8- Psychiatric illness or substance abuse that interferes with patient compliance with treatment 9- Pregnancy or breastfeeding 10- Receiving immunotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Grade on Pathological Response to Neoadjuvant Chemotherapy Diet Containing Lenlidomide and Placebo in Surgical Sample. Timepoint: after surgery. Method of measurement: patologic assessment. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRazdar sara
Tehran University of Medical Sciences
Outcome results
None listed