BridgeMD
New treatment option for Breast Cancer
Official title Omission of SLNB in CN0 Early Breast Cancer
ClinicalTrials.gov ID: NCT05935150
What this study is testing
- What it's testing
- The OMSLNB trial adopts a prospective, single-arm, non-inferiority, phase-II, open-label study design. Patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cN0 will be eligible for inclusion, enrolled patients are required to complete 2 or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, [18F]-FDG PET-MRI, eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery (BCS).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Female patients aged 18-70 years;
- Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast...
- Negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast MRI, breast...
- All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth...
- Good compliance, normal comprehension and ability to receive treatment and follow-up as required;
You likely can't join if
- Bilateral/lactating/pregnant breast cancer;
- Previous history of malignant tumor or neoplasm;
- Clinical or imaging confirmation of distant metastasis;
- History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
- Prior history of radiotherapy to the breast or chest;
- Positive pathological margins after breast-conserving surgery or mastectomy;
See the full eligibility criteria
- Female patients aged 18-70 years;
- Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery;
- Negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET);
- All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki-67 proliferation index, and further...
- Good compliance, normal comprehension and ability to receive treatment and follow-up as required;
- ECOG score 0-1;
- Patients volunteered for this study and signed the informed consent form.
- Bilateral/lactating/pregnant breast cancer;
- Previous history of malignant tumor or neoplasm;
- Clinical or imaging confirmation of distant metastasis;
- History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
- Prior history of radiotherapy to the breast or chest;
- Positive pathological margins after breast-conserving surgery or mastectomy;
- Severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection;
- Aspartate aminortransferse (AST) and Alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of...
- Inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons;
- No personal freedom and independent civil capacity;
- Presence of mental disorders, addictions, etc;
- Not eligible for enrollmentas as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
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 female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.