Status:
ACTIVE_NOT_RECRUITING
NOSTRA-Feasibility Study: A Study Looking at Ultrasound Guided Biopsies for Breast Cancer
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Roche Pharma AG
Cancer Research UK
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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 b...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04118192
Start Date
May 22 2019
End Date
December 31 2025
Last Update
January 24 2025
Active Locations (24)
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1
Basildon Hospital
Basildon, Essex, United Kingdom, SS16 5NL
2
Belfast City Hospital
Belfast, United Kingdom
3
City Hospital
Birmingham, United Kingdom, B18 7QH
4
Queen Elizabeth Hospital
Birmingham, United Kingdom