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New treatment option for TNBC, Triple Negative Breast Cancer
Official title MRI-Guided Neoadjuvant Treatment De-Escalation in Stage II-III TNBC
ClinicalTrials.gov ID: NCT07327021
What this study is testing
- What it's testing
- Breast cancer is the most common malignancy among women worldwide. Triple-negative breast cancer (TNBC), defined by the lack of estrogen receptor, progesterone receptor, and HER2 expression, comprises approximately 15% of all breast cancers and is the most aggressive subtype, associated with a higher risk of early recurrence and death compared to other breast cancer subtypes.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient is eligible per physician's discretion for the KEYNOTE-522 regimen (Neoadjuvant...
- Signed written informed consent
- Histologically confirmed primary infiltrating breast cancer with estrogen receptor expression \<1%, Progesterone receptor expression \<1%, and...
- T2-3N0, T1-3N1 disease according to TNM-staging (8th edition, AJCC).
- Nodal status must be examined by ultrasound and fine-needle aspiration or core biopsy in case of suspicious lymph nodes.
You likely can't join if
- Concurrent breastfeeding
- Concurrent contralateral or ipsilateral non-TNBC second primary infiltrating breast cancer. Contralateral or ipsilateral TNBC second primary...
- Concurrent anti-cancer treatment or another investigational drug
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Patients who have a history of a second malignancy are eligible, provided the malignancy has been adequately treated, there is no ongoing treatment...
- Has undergone excisional biopsy of the primary tumor, and/or axillary lymph node dissection prior to study treatment.
See the full eligibility criteria
Who can join
- Patient is eligible per physician's discretion for the KEYNOTE-522 regimen (Neoadjuvant paclitaxel-carboplatin-doxorubicin-cyclophosphamide-pembrolizumab)
- Signed written informed consent
- Histologically confirmed primary infiltrating breast cancer with estrogen receptor expression \<1%, Progesterone receptor expression \<1%, and without overexpression and/or amplification of HER2 according to ASCO/CAP...
- T2-3N0, T1-3N1 disease according to TNM-staging (8th edition, AJCC).
- Nodal status must be examined by ultrasound and fine-needle aspiration or core biopsy in case of suspicious lymph nodes.
- No evidence of distant metastases (Stage IV disease) on FDG-PET performed within 35 days of enrollment.
- Age ≥18
- WHO performance status ≤ 2
- Visible breast tumor on contrast enhanced MRI (no minimal longest diameter required)
- MRI breast must be performed within 35 days prior to registration
- Patients with a history of autoimmune disease are eligible for the study per treating physician's discretion.
- Laboratory requirements - within 21 days prior to enrollment:
- Adequate bone marrow function (ANC ≥1.5 x 109/l, platelets ≥100 x 109/l)
- Adequate hepatic function (ALT, AST and bilirubin ≤2.5 times upper limit of normal)
- people with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists;
- Adequate renal function: creatinine clearance \>50 ml/min estimated using the Cockcroft-Gault equation, or based on a 24-hour urine collection measurement
- LVEF ≥50% measured by echocardiography
- Women of childbearing potential and men must agree to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods (failure rate of \<1% per year,) during treatment and for at least 6...
What rules you out
- Concurrent breastfeeding
- Concurrent contralateral or ipsilateral non-TNBC second primary infiltrating breast cancer. Contralateral or ipsilateral TNBC second primary infiltrating breast cancer or DCIS is allowed.
- Concurrent anti-cancer treatment or another investigational drug
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Patients who have a history of a second malignancy are eligible, provided the malignancy has been adequately treated, there is no ongoing treatment for the second malignancy, and overall principal investigator (PI)...
- Has undergone excisional biopsy of the primary tumor, and/or axillary lymph node dissection prior to study treatment.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first...
- History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the...
The study team makes the final eligibility decision.
Where it's taking place
- Tel Aviv, Israel
- Tel Litwinsky, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tel Aviv, Israel; Tel Litwinsky, Israel. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.