strange criteria Jo.No wonder they are having trouble finding...

strange criteria Jo.No wonder they are having trouble finding participants.

I would have thought they would INCLUDE women with a prior known history. They could then compare results.

Key inclusion criteria

To be eligible for study entry subjects must satisfy all of the following criteria
* Female subjects
* Written informed consent provided for participation in the study;
* In the opinion of investigator, willing and able to comply with required study procedures;
* Histologically confirmed HER2-positive primary breast cancer;
* No prior treatment for breast cancer including surgery, radiotherapy, or systemic treatment;
* In the investigator’s judgment from previous clinical, pathological, or imaging evidence have a likelihood of having at least 1 lymph node metastasis;
* Scheduled for surgical intervention with a SLNB and/or ALND as guided by technetium-99m (99mTc) diagnostic agent injection procedure being part of the surgical plan, or scheduled for a core biopsy of a node that is clinically suspicious, or have already had a lymph node biopsy and are willing to have a second core biopsy;
* A female subject who is not pregnant or breastfeeding,

Minimum age

18 Years

Maximum age

No limit

Gender

Females

Can healthy volunteers participate?

No

Key exclusion criteria

Subjects will be excluded from the study if 1 or more of the following criterion are applicable:
* Contraindications to the use of any aid in detecting nodes during surgery including other magnetic localisation systems or 99mTc-based diagnostic agents for those subjects scheduled for a SLNB and/or ALND;
* Known hypersensitivity to iron oxide or polyethylene glycol compounds;
* For those subjects scheduled for a SLNB and/or ALND, contraindications to the use of 99mTc diagnostic agents;
*Prior history of iron overload disease;
* Known clinical or radiological evidence of distant metastases (Stage IV disease);
* Known inflammatory breast cancer;
* Prior surgical axillary procedure including SLNB or ALND on the ipsilateral side of the breast cancer primary;
* Prior history of breast cancer;
* History of lymphoma with breast or axillary node involvement;
* Previous radiation to the ipsilateral breast or axilla;
* Known metal implant in the ipsilateral axilla or in the ipsilateral chest;
* Any contraindications to MRI imaging;
* Any implant anywhere in the body that produces a magnetic field;
* Recent history of ferumoxytol therapy in the past 6 months;
* Subject received an investigational agent (treatment or diagnostic) within 30 days prior to the surgery;
* Clinically significant acute illness within 4 weeks or other illness deemed to be significant by investigator with agreement of sponsor within 5 days before Day 1;
* Subject, in the opinion of the investigator, should not participate in the study.

rticipants.