Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT04118192
Eligibility Criteria:
Inclusion Criteria:
* Patient with histological diagnosis of operable HER2-positive, ER-negative, early stage invasive breast cancer
* Tumour size ≥ 1cm and visible on US (T1c to T4d)
* Patient fit and willing to receive, or is already receiving and has received no more than five cycles of a NOSTRA-Feasibility Study approved treatment regimen, in the opinion of the responsible clinician
* Eastern Co-operative Group (ECOG) performance status of 0 or 1
* Women of child-bearing potential, prepared to adopt highly effective contraceptive measures if sexually active for at least 6 months after completion of study medication
* Female, 18 years or older
* Able to provide informed consent for the study
* Availability of embedded paraffin tumour blocks from pre-chemotherapy biopsy
* The radiology team are able and willing to perform the tumour bed core biopsies
Exclusion Criteria:
* Previous ipsilateral invasive breast cancer or Ductal Carcinoma in Situ (DCIS)
* Unequivocal evidence of distant metastatic disease at registration
* Multi-focal disease at diagnosis
* Active malignancy
* Previous chemotherapy
* Prior extensive radiotherapy (as judged by the Investigator) to bone marrow
* Risk factors precluding the safe administration of the intended cytotoxic chemotherapy regimen
* Patient unsuitable for the planned dual-targeted anti-HER2 treatment in opinion of the Investigator
* Prior diagnosis of cardiac failure
* Uncontrolled hypertension, coronary heart disease or other significant cardiac abnormality
* Bleeding diathesis
* Any evidence of other disease which in the opinion of the Investigator places the patient at high risk of treatment related complications
* Pregnant (female patients of child bearing potential must have a urine or blood Human Chorionic Gonadotropin test performed to rule out pregnancy prior to study entry)
* Patient lactating
* Patients who have received live vaccine within 4 weeks of the date of study entry
* Any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment or follow-up
* Patient unfit and/or unwilling to undergo surgery
* Patient unwilling or unable to comply with scheduled visits, treatment plan and study procedures
* Patient has started protocol non-compliant neo-adjuvant chemotherapy
* Patient has started approved neoadjuvant chemotherapy but insufficient data is available to complete relevant CRFs
* Patient has already received more than five cycles of approved neoadjuvant chemotherapy
Additional Inclusion Criteria for ctDNA Sub-Study
* Patient has not yet started neoadjuvant treatment
* Patient is willing and able to give blood samples as per ctDNA Sub-Study Guidelines
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04118192
Study Brief:
Protocol Section:
NCT04118192