Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Accelerated Partial Breast Irradiation for Early Breast Cancer

Summary: Hypothesis:
  In selected women with node-negative invasive breast cancer treated with breast conserving surgery, postoperative accelerated partial breast irradiation (APBI) limited to the region of the tumour bed delivered by 3-dimensional conformal radiation therapy (3D CRT) is technically feasible and reproducible with acceptable treatment toxicity, cosmetic outcome, and local control rate in a multicentre trial.

Detailed description: This is a TROG multicentre feasibility study of APBI using 3D CRT in selected women with node-negative breast cancer treated by breast conserving surgery with negative margins.
  This is a one-arm feasibility study in which the primary endpoint is the feasibility rate for APBI using 3D CRT. This is defined as the proportion of eligible patients treated without a major protocol deviation. Secondary endpoints include radiation toxicity, cosmetic outcome, quality of life, time to ipsilateral breast recurrence, disease-free survival, and overall survival.
  Primary objectives: To evaluate the technical feasibility and reproducibility of APBI limited to the region of the tumour bed using 3D CRT following breast conserving surgery.
  Secondary objectives:
  -  To assess the acute and long term toxicity of APBI using 3D CRT.
  -  To examine the cosmetic outcome of women with breast cancer treated by breast conserving surgery and APBI using 3D CRT.
  -  To determine the time to ipsilateral breast recurrence, disease free survival and overall survival of women with node-negative breast cancer completely resected by breast conserving surgery followed by APBI using 3D CRT.
  -  To assess the quality of life of women with node-negative breast cancer treated by breast conserving surgery and APBI using 3D CRT.

Eligibility: Inclusion Criteria:
  Patients must fulfill all of the following criteria for admission to study:
  -  Women aged >= 50 years.
  -  Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.
  -  Bilateral mammograms performed within 6 months prior to registration.
  -  Treated with breast conserving surgery (primary excision or re-excision) with negative radial resection margins of >= 2 mm* for both the invasive and if present, associated intraductal tumour.
  *Patients with superficial or deep resection margin of < 2 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.
  -  Unifocal tumour measuring ≤ 20 mm in maximum microscopic dimension.
  -  Negative nodal status determined by sentinel node biopsy, axillary dissection, or for women > 70 years of age, clinical examination.
  -  No evidence of distant metastasis.
  -  Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy.
  -  Ability to tolerate protocol therapy.
  -  Protocol therapy must commence no later than 12 weeks from the last surgical procedure or 8 weeks from the last dose of chemotherapy.
  -  Availability for long-term follow-up.
  -  Women of child-bearing potential must use adequate contraception during RT.
  -  Written informed consent.
  Exclusion Criteria:
  Patients who fulfill any of the following criteria are not eligible for admission to study:
  -  Multifocal or multicentric tumours.
  -  Clinical or pathologic evidence of any of the following tumour features: extension to chest wall (excluding pectoralis muscle); oedema (including peau d'orange) or ulceration of skin; satellite skin nodules confined to the same breast; and inflammatory carcinoma.
  -  Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25% of the primary invasive tumour and present adjacent to the primary tumour).
  -  Node-positive breast cancer determined by sentinel node biopsy, axillary dissection, or in women > 70 years of age, clinical examination.
  -  Inability to localise surgical cavity on CT scans with no evidence of a surgical cavity, seroma or surgical clips delineating the tumour bed.
  -  Treatment target volume estimated to occupy > 25% of the ipsilateral whole breast volume.
  -  Synchronous or metachronous bilateral invasive or intraductal breast cancer.
  -  Locally recurrent breast cancer.
  -  Ipsilateral breast implant.
  -  Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).
  -  Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry.
  -  Women who are pregnant or lactating.
  -  Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol

Relevance to patient case: not relevant