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

CCTU- Cancer Theme

Status: Unknown

Conditions: Breast Cancer

Treatments: Radiation: Intensity modulated radiotherapy (IMRT); Procedure: Breast conserving surgery; Drug: Endocrine therapy

Study type: Observational

Funder types: Other

Identifiers

NCT03818100

Neo-RT

Details and patient eligibility

About

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.

Enrollment: 43 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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