In women with breast cancer, does Accelerated Partial Breast Irradiation (APBI) demonstrate acceptable general cosmesis with an improved quality of life?

Phase 2

Recruiting

• Conditions: Cancer - Breast; Breast cancer.

• Registration Number: ACTRN12613000551796
• Lead Sponsor: Dr Yaw Chin.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

a) Females more than 50 years of age.
b) Performance status 0-2.
c) Unicentric, invasive ductal carcinoma measuring 3cm in maximal diameter or less.
d) Negative surgical resection margins, defined as no tumour at the inked margins.
e) No extensive intraductal component, as defined by >25% of the invasive ductal tumour being comprised of intraductal carcinoma or ductal carcinoma in-situ being also present in the adjacent breast tissue.
f) No lymphovascular invasion.
g) No cutaneous involvement, including Paget’s disease of the nipple, oedema (peau d’orange) or inflammatory carcinoma.
h) No axillary nodal involvement on sentinel node biopsy or axillary nodal dissection.
i) No distant metastases.
j) A clearly defined surgical excision cavity and a planning target volume to whole breast volume ratio of >25%, based on the postoperative CT scan.
k) Provision of verbal and written consent, including willingness to comply with the specified treatment protocol, follow-up visits and examinations.

Exclusion Criteria

a) Locally recurrent breast cancer.
b) History of concurrent or previous malignancies (except for non-melanomatous skin cancer or carcinoma in-situ of the uterine cervix).
c) Her-2 receptor positive tumours.
d) Microscopic assessment of tumour resection margins cannot be defined accurately.
e) Women who are pregnant or lactating.
f) Pre-existing connective tissue disorder such as scleroderma, systemic lupus erythematosis and dermatomyositis.
g) Patients with ipsilateral breast implants.
h) Previous radiation treatment to the ipsilateral breast or thoracic region.
i) Psychiatric or addictive disorders that preclude patients from giving informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified