nostra-feasibility study: a study looking at ultrasound guided biopsies for breast cancer

Conditions: Breast Cancer

Summary: a prospective non-randomised multi-centre feasibility study to assess if patients with residual cancer following dual-targeted neoadjuvant chemotherapy treatment for her2-positive, er-negative early breast cancer can be identified by multiple ultrasound (us)-guided tumour bed core biopsies

the nostra-feasibility study is designed to determine if it is safe to omit surgery after the planned neoadjuvant chemotherapy plus dual-targeted anti-her2 treatment. the study is needed to determine whether patients with residual cancer can be identified by histological examination of multiple ultrasound-guided tumour bed core biopsies following dual-targeted neoadjuvant treatment for her2-positive, er-negative early primary breast cancer and whether there is concordance between local pathology reporting and central pathology reporting by the trials expert pathologists.

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

Keywords: breast cancer her2 positive er negative tumour bed core biopsies