Breast CancerNeo-RTNCT03818100
Neo-RT: A Study Investigating Whether Changing the Sequence of Treatments (Starting Radiotherapy Followed by Hormone Therapy Before Surgery) is Feasible
An observational study of Breast Cancer, run by CCTU- Cancer Theme at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intensity modulated radiotherapy (IMRT), Endocrine therapy and Breast conserving surgery
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Mar 2018to 15 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with invasive breast cancer for planned treatment with neo-adjuvant endocrine therapy, where radiotherapy may make breast conserving surgery easier.
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: Neo-RT: Pre-operative Breast Intensity Modulated Radiotherapy in Patients Receiving Neo-adjuvant Hormonal Treatment for Breast Cancer - a Feasibility Study.
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.
- Conditions
- Breast Cancer
- Being tested
- Intensity modulated radiotherapy (IMRT), Endocrine therapy, Breast conserving surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity modulated radiotherapy (IMRT)Radiation
Simultaneous integrated boost technique using IMRT: 48 Gray (Gy) and 40 Gy will treat tumour and breast tissue respectively, in 15 fractions over 3 weeks.
Endocrine therapyDrug
Endocrine therapy will commence following completion of radiotherapy, and will continue for 20 weeks.
Breast conserving surgeryProcedure or surgery
Surgery carried out using local protocol following completion of endocrine therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients successfully completing neo-adjuvant IMRT and endocrine treatment followed by beast surgery, as per study protocol.
Successful completion of IMRT is defined as:
- Treatment received was either 48 Gy/15# or 40 Gy/15# with sequential boost
- Treatment received was 'other', but the reason for different schedule was not due to toxicity related from the radiotherapy
- Radiotherapy treatment was not delayed by 5 days or more
- Radiotherapy treatment was delayed by 5 days or more, but the reason was not due to toxicity related from the radiotherapy
Successful completion of endocrine treatment is defined as:
- Patient received at least 80% of endocrine treatment received
- Patient did not receive 80% of endocrine treatment, but the reason was not due to toxicity or toxicity related from radiotherapy or endocrine
Successful surgery is defined as:
- Planned date of surgery is not delayed
- Planned date of surgery is delayed, but the reason was not due to toxicity or toxicity related to radiotherapy or endocrine treatment.
Measured: 6 months
Secondary outcomes (7)
Acute radiotherapy toxicity following IMRT, assessed by CTCAE v4.03
Acute radiotherapy toxicity following IMRT, assessed by CTCAE v4.03
Measured: 3 weeks
Mastectomy rate
Analysis will be descriptive, and in accordance to the statistical analysis plan.
Measured: 6 months
Peri/post operative complications
Including:
- Length of stay
- Unplanned return to theatre (and reason)
- Use of antibiotics for wound related issues
- Number of clinic attendances for wound related problems
Measured: 9 months
Volume of residual tumour and response to treatment
There will be a central review (2 readers) of all primary surgery histopathology reports for the secondary endpoint of pathological complete response (pCR). The histopathology slides from the surgical resection will be requested for central assessment of residual disease for all cases where there has not been a pCR. The variables that will be recorded include residual invasive tumour size in two dimensions, residual invasive tumour cellularity, number of lymph node metastases and size of the largest metastasis. A representative tumour tissue block will be selected and requested from the laboratory. Sections from the block will be taken for staining with ER and Ki67 to allow calculation of the histological assessment of residual tumour burden, and cores taken as per the protocol.
Measured: 6 months
Late normal tissue toxicity, as assessed by: 1) clinicians
Clinician - post-radiotherapy questionnaire (with permission from IMPORT Trial Management Group and Dr Penny Hopwood)
Measured: Annually for 5 years
Late normal tissue toxicity, as assessed by: 2) Patient Reported Outcome Measurements (PROMs)
Patient Reported Outcome Measure - Validated Breast-Q questionnaire
Measured: Annually for 5 years
Late normal tissue toxicity, as assessed by: 2) Patient Reported Outcome Measurements (PROMs)
Patient Reported Outcome Measure - EORTC IL1 Modified BRECON23 PROM questionnaire.
Measured: Annually for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start26 Mar 2018
- Primary completion29 Sep 2021
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCTU- Cancer Theme
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Now, CRUK Cambridge Institute
- Responsible party
- Sponsor-investigator, CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Charlotte E Coles, MB ChB, MRCP, FRCR, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818100
- Sponsor's protocol ID
- Neo-RT
- Acronym
- Neo-RT
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2018
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo-RT: Pre-operative Breast Intensity Modulated Radiotherapy in Patients Receiving Neo-adjuvant Hormonal Treatment for Breast Cancer - a Feasibility Study.
- ClinicalTrials.gov ID
- NCT03818100
- Acronym / sponsor ID
- Neo-RT / Neo-RT
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- CCTU- Cancer ThemeUniversity, hospital or other
- Collaborators
- Breast Cancer Now, CRUK Cambridge Institute
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with invasive breast cancer for planned treatment with neo-adjuvant endocrine therapy, where radiotherapy may make breast conserving surgery easier.
Key inclusion criteria (12 listed)
- Written informed consent to participate
- Female
- Aged 18 years and older
- ECOG performance status 0-2
- Histology confirmed invasive breast cancer
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity modulated radiotherapy (IMRT)Simultaneous integrated boost technique using IMRT: 48 Gray (Gy) and 40 Gy will treat tumour and breast tissue respectively, in 15 fractions over 3 weeks. | Radiation | – |
| Endocrine therapyEndocrine therapy will commence following completion of radiotherapy, and will continue for 20 weeks. | Drug | – |
| Breast conserving surgerySurgery carried out using local protocol following completion of endocrine therapy. | Procedure or surgery | – |
Primary outcome
The proportion of patients successfully completing neo-adjuvant IMRT and endocrine treatment followed by beast surgery, as per study protocol.
Time frame: 6 months
Successful completion of IMRT is defined as: * Treatment received was either 48 Gy/15# or 40 Gy/15# with sequential boost * Treatment received was 'other', but the reason for different schedule was not due to toxicity related from the radiotherapy * Radiotherapy treatment was not delayed by 5 days or more * Radiotherapy treatment was delayed by 5 days or more, but the reason was not due to toxicity related from the radiotherapy Successful completion of endocrine treatment is defined as: * Patient received at least 80% of endocrine treatment received * Patient did not receive 80% of endocrine treatment, but the reason was not due to toxicity or toxicity related from radiotherapy or endocrine Successful surgery is defined as: * Planned date of surgery is not delayed * Planned date of surgery is delayed, but the reason was not due to toxicity or toxicity related to radiotherapy or endocrine treatment.
7 secondary outcomes
Acute radiotherapy toxicity following IMRT, assessed by CTCAE v4.03
Time frame: 3 weeks
Mastectomy rate
Time frame: 6 months
Peri/post operative complications
Time frame: 9 months
Volume of residual tumour and response to treatment
Time frame: 6 months
Late normal tissue toxicity, as assessed by: 1) clinicians
Time frame: Annually for 5 years
Late normal tissue toxicity, as assessed by: 2) Patient Reported Outcome Measurements (PROMs)
Time frame: Annually for 5 years
Late normal tissue toxicity, as assessed by: 2) Patient Reported Outcome Measurements (PROMs)
Time frame: Annually for 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte E Coles, MB ChB, MRCP, FRCR, PhD principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by CCTU- Cancer Theme at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients successfully completing neo-adjuvant IMRT and endocrine treatment followed by beast surgery, as per study protocol. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.