Phase II Clinical Trial of Hyper-Accelerated Partial Breast Radiotherapy in Women with Invasive Non-Lobular Breast Carcinoma

Not Applicable

Recruiting

• Conditions: Early stage breast cancer; Cancer - Breast

• Registration Number: ACTRN12621001410842
• Lead Sponsor: South Eastern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-20
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 640

Inclusion Criteria

a)Women, aged 40 years and above.
b)Performance status 0-2.
c)Unicentric, invasive breast carcinoma of non-lobular histology with a maximal microscopic dimension of less than or equal to 3cm.
d)Treated with breast conserving surgery.
e)Bilateral breast imaging with mammograms and ultrasound scans no longer than 3 months prior to surgery.
f)Negative radial resection margins either from primary excision or re-excision, defined as:
•no tumour at inked margin for the invasive tumour component and
•greater than or equal to 2mm from the inked margin for the associated intraductal tumour component.
Patients with positive resection margins at either superficial or deep margins are still eligible if the surgeon confirms that all intervening breast tissue has been removed from the subcutaneous tissue or the pectoralis fascia.
g)No extensive intraductal component (EIC), defined as intraductal component constituting greater than or equal to 25% of the primary tumour with intraductal foci and/or adjacent to the primary tumour.
h)No lymphovascular invasion (LVI), defined as carcinoma cells present within a definite, endothelial-lined space (lymphatic and/or blood vessel), in peri-tumoural tissues.
Possible or suspicious LVI, defined as carcinoma cells present within a space with the appearance of a vessel but without a recognisable endothelial lining, is allowed.
i)No cutaneous involvement, including Paget’s disease of the nipple, oedema (peau d’orange), satellite skin nodules, skin ulceration or inflammatory carcinoma.
j)Oestrogen receptor positive.
k)Human epidermal growth factor receptor 2 (HER-2) negative, as determined by immunohistochemistry (IHC) staining and/or dual in-situ hybridisation (D-ISH) techniques.
l)Negative axillary lymph node involvement on histopathology, classified as either:
•no tumour cells OR
•isolated tumour cells (ITC), defined by a single or cluster of tumour cells, no larger than 0.2mm in maximal dimension.
m)Clearly defined surgical excision cavity on both assessment ultrasound and computed tomography (CT) scans.
n)Ratio of excision cavity volume to the whole breast volume less than or equal to 25%, defined on the assessment CT scan.
o)Willingness to give written informed consent.
p)Willingness to participate and comply with the study protocol.

Exclusion Criteria

a)Multifocal or multicentric breast cancer.
b)Inability to determine microscopic resection margins of the primary breast cancer.
c)Locally recurrent breast cancer.
d)History of prior malignancies, except for non-melanomatous skin cancer, carcinoma in-situ of the uterine cervix or contralateral invasive non-lobular breast cancer.
e)Pre-existing connective tissue disorder, such as scleroderma, systemic lupus erythematosis and dermatomyositis.
f)Prior radiation treatment to the ipsilateral breast or thoracic region.
g)Women who are lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
h)Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
i)Patients who are unwilling to have their blood or tissue samples collected and stored for further genetic testing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compliance with dosimetric parameters assessed using 3-D treatment planning software (Oncentra Brachy)[Compliance with dosimetric parameters will be assessed at the time of treatment planning post catheters implantation.];Non-inferiority rate of ipsilateral breast tumour recurrence (IBTR) assessed by comparing to the control group of patients from the GEC-ESTRO trial. The IBTR data is collected by clinical follow-up with patients.[IBTR will be assessed at 5 years timepoint post-intervention completion.]