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-guided tumour bed core biopsies
A prospective multi-centre, non-randomised, single-arm feasibility study to inform a future phase III randomised trial.
To determine whether patients with residual cancer can be identified by histological examination of multiple ultra sound-guided tumour bed core biopsies following dual-targeted neoadjuvant treatment for HER2-positive, ER-negative early primary breast cancer.
Key inclusion criteria: Adult females with HER2 +ve, ER-ve, tumour size >1cm early breast cancer visible on ultrasound. Fit for chemotherapy, dual targeted anti HER2 therapy and surgery.
- 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 already started approved chemotherapy, has received five or fewer cycles, has had baseline investigations and this data can be collected retrospectively.
- Patient fit and willing to receive one of the approved treatment regimens in the opinion of the responsible clinician/OR patient already started approved chemotherapy, has received five or fewer cycles, has had baseline investigations
- 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, aged ≥ 18 years
- Able to provide written 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
- Previous invasive breast cancer
- Unequivocal evidence of distant metastatic disease at registration
- Active malignancy of non-breast origin
- 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)
- Lactating patients
- 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 non-protocol compliant neo-adjuvant chemotherapy
- Patient has started approved neo-adjuvant chemotherapy but retrospective data is not available
- Patient has received more than five cycles of approved neo-adjuvant chemotherapy
Planned sample size
150 Patients will be recruited over 18 months with a 12 month treatment period
Total number of sites planned
Recruitment end date May 2021.
Patients will followed-up at 12 months and at 5 years
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