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IRCT20250927067373N1 IRCT 2025-10-20 Tehran University of Medical Sciences Efficacy, safety and tolerability of adding lenalidomide to neoadjuvant chemotherapy for tripple negative breast cancer Efficacy, safety and tolerability of adding lenalidomide to neoadjuvant chemotherapy for tripple negative breast cancer 2025-10-11 anticipated 20 Recruiting https://irct.ir/trial/86426 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is done one by one, Blinding description: The evaluating pathologist is unaware of the grouping and type of intervention. 2 Breast cancer. 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 regimen used in this study is similar to the control group of the keynote 522 study and is 4 courses of paclitaxel 80 mg/m2 and carboplatin AUC 1.5 every week for 3 weeks (total 12 weeks) followed by 4 courses of doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 every 3 weeks (total 12 weeks). Patients who have entered the study will be randomly assigned to two groups in a 1:1 manner: the first group will receive the above regimen plus lenalidomide 10 mg for 2 weeks on and 1 week off. Patients will also receive aspirin for VTE prophylaxis. The second group will receive the above regimen plus a placebo in a similar manner to lenalidomide. Before randomization, patients will be classified based on lymph node involvement (positive or negative) and tumor size (T1/T2 vs. T3/T4). During the study, a physician will be responsible for recording all adverse events that occurred for patients according to the CTCAE version 5 guidelines. Changes in drug doses, drug discontinuations, or delays in chemotherapy courses based on adverse events will all be recorded.Patients will undergo surgery (breast conservation or mastectomy with sentinel lymph node evaluation or axillary dissection) within 3 to 6 weeks of the last chemotherapy cycle. Response to neoadjuvant therapy will be determined based on histological evaluation of the surgical breast specimen and axillary lymph nodes.. Yes - There is a plan to make this available What will be shared: article When: one year To whom: no one Conditions: article Where to obtain: drsrazdar@gmail.com How to obtain: drsrazdar@gmail.com Comments:
public Razdar sara
Tohid Square - Imam Khomeini Hospital
Tehran Iran (Islamic Republic of) 1419733141 +98 912 071 5864 drsrazdar@gmail.com Tehran University of Medical Sciences scientific Razdar sara
Tehran - Imam Khomeini Hospital
Tehran Iran (Islamic Republic of) 1419733141 +98 912 071 5864 drsrazdar@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Female 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 Treatment - Drugs 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 regimen used in this study is similar to the control group of the keynote 522 study and is 4 courses of paclitaxel 80 mg/m2 and carboplatin AUC 1.5 every week for 3 weeks (total 12 weeks) followed by 4 courses of doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 every 3 weeks (total 12 weeks). Patients who have entered the study will be randomly assigned to two groups in a 1:1 manner: the first group will receive the above regimen plus lenalidomide 10 mg for 2 weeks on and 1 week off. Patients will also receive aspirin for VTE prophylaxis. The second group will receive the above regimen plus a placebo in a similar manner to lenalidomide. Before randomization, patients will be classified based on lymph node involvement (positive or negative) and tumor size (T1/T2 vs. T3/T4). During the study, a physician will be responsible for recording all adverse events that occurred for patients according to the CTCAE version 5 guidelines. Changes in drug doses, drug discontinuations, or delays in chemotherapy courses based on adverse events will all be recorded.Patients will undergo surgery (breast conservation or mastectomy with sentinel lymph node evaluation or axillary dissection) within 3 to 6 weeks of the last chemotherapy cycle. Response to neoadjuvant therapy will be determined based on histological evaluation of the surgical breast specimen and axillary lymph nodes. Disease Grade on Pathological Response to Neoadjuvant Chemotherapy Diet Containing Lenlidomide and Placebo in Surgical Sample. Timepoint: after surgery. Method of measurement: patologic assessment. Tehran University of Medical Sciences Approved 2024-12-22 Ethics committee of tehran University of Medical Sciences Imam Khomeini Hospital Complex, end of Keshavarz Boulevard tehran Tehran Iran (Islamic Republic of)