Clinical trial NCT03818100: Neo-RT: A Study Investigating Whether Changing the Sequence of Treatments (Starting Radiotherapy Followed by Hormone Therapy Before Surgery) is Feasible
Official title: Neo-RT: Pre-operative Breast Intensity Modulated Radiotherapy in Patients Receiving Neo-adjuvant Hormonal Treatment for Breast Cancer - a Feasibility Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Breast Cancer Now
name: CRUK Cambridge Institute
First posted: 2019-01-28
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with invasive breast cancer for planned treatment with neo-adjuvant endocrine therapy, where radiotherapy may make breast conserving surgery easier.

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 area with the lump only) can offer less extensive surgery and improved breast appearance, which can therefore increase well-being.

Intensity-modulated radiotherapy (IMRT) closely shapes the radiation beam to the cancer and is currently given after breast surgery. A new combination of IMRT followed by hormone treatment given before surgery, may increase the possibility of breast conservation.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: The proportion of patients successfully completing neo-adjuvant IMRT and endocrine treatment followed by beast surgery, as per study protocol.
timeFrame: 6 months
Secondary outcomes:
measure: Acute radiotherapy toxicity following IMRT, assessed by CTCAE v4.03
timeFrame: 3 weeks
measure: Mastectomy rate
timeFrame: 6 months
measure: Peri/post operative complications
timeFrame: 9 months
measure: Volume of residual tumour and response to treatment
timeFrame: 6 months
measure: Late normal tissue toxicity, as assessed by: 1) clinicians
timeFrame: Annually for 5 years
measure: Late normal tissue toxicity, as assessed by: 2) Patient Reported Outcome Measurements (PROMs)
timeFrame: Annually for 5 years
measure: Late normal tissue toxicity, as assessed by: 2) Patient Reported Outcome Measurements (PROMs)
timeFrame: Annually for 5 years
Other outcomes:
measure: Exploratory research will be carried out to identify possible molecular and radiological biomarkers of response
timeFrame: 6 months post last patient recruited
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: University of Cambridge
name: Charlotte E Coles, MB ChB, MRCP, FRCR, PhD
role: PRINCIPAL_INVESTIGATOR
References: