Status:
UNKNOWN
Neo-RT: A Study Investigating Whether Changing the Sequence of Treatments (Starting Radiotherapy Followed by Hormone Therapy Before Surgery) is Feasible
Lead Sponsor:
CCTU- Cancer Theme
Collaborating Sponsors:
Breast Cancer Now
CRUK Cambridge Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
Four in 10 women diagnosed with breast cancer undergo mastectomy with or without breast reconstruction and less than half are satisfied with how they look unclothed. Breast conservation (removing the ...
Eligibility Criteria
Inclusion
- Written informed consent to participate
- Female
- Aged 18 years and older
- ECOG performance status 0-2
- Histology confirmed invasive breast cancer
- ER positive (Allred score 6-8)
- HER2 negative
- Palpable size ≥20mm
- Grade I-II (or grade III if considered not suitable for neo-adjuvant chemotherapy)
- Considered that radiotherapy will make breast conserving surgery easier
- No evidence of non-breast malignancy if treated with curative intent unless the patient has been disease free ≥5 years
- Unifocal or multifocal disease, i.e. tumour in the same quadrant and breast conserving surgery still feasible
Exclusion
- Contraindications to breast radiotherapy or neo-adjuvant endocrine therapy
- Bilateral breast cancer
- Metastatic cancer
- Multicentric disease
- Concomitant medical/psychiatric problems preventing completion of study treatment or follow-up
- Pregnancy
- Breast feeding
Key Trial Info
Start Date :
March 26 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03818100
Start Date
March 26 2018
End Date
December 31 2022
Last Update
July 27 2021
Active Locations (1)
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1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ