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Neo-RT: A Study Investigating Whether Changing the Sequence of Treatments (Starting Radiotherapy Followed by Hormone Therapy Before Surgery) is Feasible (Neo-RT)

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ClinicalTrials.gov Identifier: NCT03818100
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : July 27, 2021
Sponsor:
Collaborators:
Breast Cancer Now
CRUK Cambridge Institute
Information provided by (Responsible Party):
CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment
Breast Cancer Radiation: Intensity modulated radiotherapy (IMRT) Drug: Endocrine therapy Procedure: Breast conserving surgery

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Study Type : Observational
Estimated Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neo-RT: Pre-operative Breast Intensity Modulated Radiotherapy in Patients Receiving Neo-adjuvant Hormonal Treatment for Breast Cancer - a Feasibility Study.
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Radiation: 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.
  • Drug: Endocrine therapy
    Endocrine therapy will commence following completion of radiotherapy, and will continue for 20 weeks.
  • Procedure: Breast conserving surgery
    Surgery carried out using local protocol following completion of endocrine therapy.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Acute radiotherapy toxicity following IMRT, assessed by CTCAE v4.03 [ Time Frame: 3 weeks ]
    Acute radiotherapy toxicity following IMRT, assessed by CTCAE v4.03

  2. Mastectomy rate [ Time Frame: 6 months ]
    Analysis will be descriptive, and in accordance to the statistical analysis plan.

  3. Peri/post operative complications [ Time Frame: 9 months ]

    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

  4. Volume of residual tumour and response to treatment [ Time Frame: 6 months ]
    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.

  5. Late normal tissue toxicity, as assessed by: 1) clinicians [ Time Frame: Annually for 5 years ]
    Clinician - post-radiotherapy questionnaire (with permission from IMPORT Trial Management Group and Dr Penny Hopwood)

  6. Late normal tissue toxicity, as assessed by: 2) Patient Reported Outcome Measurements (PROMs) [ Time Frame: Annually for 5 years ]
    Patient Reported Outcome Measure - Validated Breast-Q questionnaire

  7. Late normal tissue toxicity, as assessed by: 2) Patient Reported Outcome Measurements (PROMs) [ Time Frame: Annually for 5 years ]
    Patient Reported Outcome Measure - EORTC IL1 Modified BRECON23 PROM questionnaire.


Other Outcome Measures:
  1. Exploratory research will be carried out to identify possible molecular and radiological biomarkers of response [ Time Frame: 6 months post last patient recruited ]

    Exploratory investigation of potential biomarkers include:

    • ctDNA,
    • PBMCs,
    • Tumour molecular profiles,
    • Immunohistochemical/immunofluorescence markers of:

    Immune response (TILs) Tumour proliferation (Ki67, Geminin) DNA damage response and cell cycle checkpoint activation (including 53BP1, RAD51, ATM1, BRCA1, p53, p21 and p-chk-1) Tumour microenvironment (hypoxia)

    - Multiplexed single cell proteomics of both cellular suspensions (including whole blood) and intact tissues, to investigate the immune response and other novel markers

    Since the identification of new biomarkers correlating with disease activity and the efficacy or safety of treatment is rapidly evolving, the definitive list of biomarkers remains to be determined. However they will be detailed in an appropriate analysis plan prior to undertaking any sample analysis.



Biospecimen Retention:   Samples With DNA
Tumour tissue samples, blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818100


Contacts
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Contact: Victoria Ingleson, BSc 01223 349702 victoria.ingleson@addenbrookes.nhs.uk
Contact: Anne-Laure Vallier 01223 348086 anne-laure.vallier@addenbrookes.nhs.uk

Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Meena Murthy, BSc    01223 349702    meena.murthy@addenbrookes.nhs.uk   
Contact: Anne-Laure Vallier    01223 348086    anne-laure.vallier@addenbrookes.nhs.uk   
Principal Investigator: Charlotte Coles         
Sponsors and Collaborators
CCTU- Cancer Theme
Breast Cancer Now
CRUK Cambridge Institute
Investigators
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Principal Investigator: Charlotte E Coles, MB ChB, MRCP, FRCR, PhD University of Cambridge
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Responsible Party: CCTU- Cancer Theme, Dr Charlotte Coles, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03818100    
Other Study ID Numbers: Neo-RT
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases