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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-26

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type RADIATION

Endocrine therapy

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

Intervention Type DRUG

Breast conserving surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No