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

NCT03818100 | Unknown DMC

• 1 other identifier: Neo-RT
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (7)

• Acute radiotherapy toxicity following IMRT, assessed by CTCAE v4.03

  3 weeks

• Mastectomy rate

  6 months

• Peri/post operative complications

  9 months

• Volume of residual tumour and response to treatment

  6 months

• Late normal tissue toxicity, as assessed by: 1) clinicians

  Annually for 5 years

Other Outcomes (1)

• Exploratory research will be carried out to identify possible molecular and radiological biomarkers of response

  6 months post last patient recruited

Interventions

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 therapy DRUG

Endocrine therapy will commence following completion of radiotherapy, and will continue for 20 weeks.

Breast conserving surgery PROCEDURE

Surgery carried out using local protocol following completion of endocrine therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CCTU- Cancer Theme: lead
• Breast Cancer Now: collaborator
• CRUK Cambridge Institute: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumour tissue samples, blood samples

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Mastectomy; Surgical Procedures, Operative

Study Officials

• Charlotte E Coles, MB ChB, MRCP, FRCR, PhD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Ingleson, BSc

CONTACT

01223 349702; victoria.ingleson@addenbrookes.nhs.uk

Anne-Laure Vallier

CONTACT

01223 348086; anne-laure.vallier@addenbrookes.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Charlotte Coles

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: January 28, 2019
• Study Start: March 26, 2018
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

GB (1)