Determining the efficacy, safety, and tolerability of adding lenalidomide to neoadjuvant chemotherapy regimen in patients with triple-negative breast cancer
Design
This research project is a pilot study in the form of a randomized, single-blind trial.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
According to the entry and exit criteria recorded on the previous page.
Intervention groups
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).
Main outcome variables
This information will help clinicians use effective, less-complicated, and less-costly treatment methods in neoadjuvant chemotherapy for triple-negative breast cancer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250927067373N1
Registration date:2025-10-20, 1404/07/28
Registration timing:registered_while_recruiting
Last update:2025-10-20, 1404/07/28
Update count:0
Registration date
2025-10-20, 1404/07/28
Registrant information
Name
sara razdar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 920 071 5864
Email address
drsrazdar@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-10-11, 1404/07/19
Expected recruitment end date
2026-10-22, 1405/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy, safety and tolerability of adding lenalidomide to neoadjuvant chemotherapy for tripple negative breast cancer
Public title
Efficacy, safety and tolerability of adding lenalidomide to neoadjuvant chemotherapy for tripple negative breast cancer
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done one by one.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluating pathologist is unaware of the grouping and type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex, end of Keshavarz Boulevard
City
tehran
Province
Tehran
Postal code
1419733141
Approval date
2024-12-22, 1403/10/02
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.396
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Disease Grade on Pathological Response to Neoadjuvant Chemotherapy Diet Containing Lenlidomide and Placebo in Surgical Sample
Timepoint
after surgery
Method of measurement
patologic assessment
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran - Imam Khomeini Hospital
Full name of responsible person
Razdar sara
Street address
Tohid Square - Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 912 071 5864
Email
drsrazdar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
razdar sara
Street address
Tohid Square - Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 912 071 5864
Email
drsrazdar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razdar sara
Position
Specialist Assistant
Latest degree
Subspecialist
Other areas of specialty/work
hemato-oncology
Street address
Tohid Square - Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 912 071 5864
Email
drsrazdar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razdar sara
Position
Specialist Assistant
Latest degree
Subspecialist
Other areas of specialty/work
hemato-oncology
Street address
Tehran - Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 912 071 5864
Email
drsrazdar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razdar sara
Position
Specialist Assistant
Latest degree
Subspecialist
Other areas of specialty/work
hemato-oncology
Street address
Tohid Square - Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
1419733141
Email
drsrazdar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
article
When the data will become available and for how long
one year
To whom data/document is available
no one
Under which criteria data/document could be used
article
From where data/document is obtainable
drsrazdar@gmail.com
What processes are involved for a request to access data/document