Can patients with residual cancer after chemotherapy for early breast cancer be identified with multiple ultrasound-guided biopsies?
- Conditions
- Breast cancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN17170034
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 150
Current inclusion criteria as of 07/02/2022:
1. Patient with histological diagnosis of operable HER2-positive, ER-negative, early stage invasive breast cancer
2. Tumour size =1cm and visible on US (T1c to T4d)
3. Patient fit and willing to receive a NOSTRA-Feasibility Study approved treatment regimen in the opinion of the responsible clinician.
4. Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
5. 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
6. Female, 18 years or older
7. Able to provide written informed consent for the study
8. Availability of embedded paraffin tumour blocks from pre-chemotherapy biopsy
9. The radiology team are able and willing to perform the tumour bed core biopsies
Additional Inclusion Criteria for ctDNA Sub-Study
1. Patient has not yet started neoadjuvant treatment.
2. Patient is willing and able to give blood samples as per ctDNA Sub-Study Guidelines
_____
Previous inclusion criteria:
1. Patient with histological diagnosis of operable HER2-positive, ER-negative, early stage invasive breast cancer
2. Tumour size = 1cm and visible on US (T1c to T4d)
3. Patient fit and willing to receive one of the three planned NICE approved treatment regimens in the opinion of the responsible clinician
4. Eastern Co-operative Group (ECOG) performance status of 0 or 1
5. Women of childbearing potential, prepared to adopt highly effective contraceptive measures if sexually active for at least 6 months after completion of study medication
6. Female, aged = 18 years
7. Able to provide written informed consent for the study
8. Availability of embedded paraffin tumour blocks from pre-chemotherapy biopsy
Current exclusion criteria as of 07/02/2022:
1. Previous ipsilateral invasive breast cancer or Ductal Carcinoma in Situ (DCIS)
2. Unequivocal evidence of distant metastatic disease at registration
3. Multi-focal disease at diagnosis
4. Active malignancy
5. Previous chemotherapy
6. Prior extensive radiotherapy (as judged by the Investigator) to bone marrow
7. Risk factors precluding the safe administration of the intended cytotoxic chemotherapy regimen
8. Patient unsuitable for the planned dual-targeted anti-HER2 treatment in opinion of the Investigator
9. Prior diagnosis of cardiac failure
10. Uncontrolled hypertension, coronary heart disease or other significant cardiac abnormality
11. Bleeding diathesis
12. Any evidence of other disease which in the opinion of the Investigator places the patient at high risk of treatment related complications
13. 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)
14. Patient lactating
15. Patients who have received live vaccine within 4 weeks of the date of study entry
16. Any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment or follow-up
17. Patient unfit and/or unwilling to undergo surgery
18. Patient unwilling or unable to comply with scheduled visits, treatment plan and study procedures
19. Patient has started protocol non-compliant neoadjuvant chemotherapy
20. Patient has started approved neoadjuvant chemotherapy but insufficient data is available to complete relevant CRFs
21. Patient has already received more than five cycles of approved neoadjuvant chemotherapy
_____
Previous exclusion criteria:
1. Previous invasive breast cancer
2. Unequivocal evidence of distant metastatic disease at registration
3. Active malignancy of non-breast origin
4. Previous chemotherapy
5. Prior extensive radiotherapy (as judged by the Investigator) to bone marrow
6. Risk factors precluding the safe administration of the intended cytotoxic chemotherapy regimen
7. Patient unsuitable for the planned dual-targeted anti-HER2 treatment in opinion of the Investigator
8. Prior diagnosis of cardiac failure
9. Uncontrolled hypertension, coronary heart disease or other significant cardiac abnormality
10. Bleeding diathesis
11. Any evidence of other disease which in the opinion of the Investigator places the patient at high risk of treatment related complications
12. 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)
13. Patient lactating
14. Patients who have received live vaccine within 4 weeks of the date of study entry
15. Any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment or follow-up
16. Patient unfit and/or unwilling to undergo surgery
17. Patient unwilling or unable to comply with scheduled visits, treatment plan and study procedures
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method