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A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.


N/A
50 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility rate of APBI using 3D conformal radiation therapy

Outcome Time Frame:

First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial)

Safety Issue:

No

Principal Investigator

Boon Chua

Investigator Role:

Study Chair

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia

Authority:

Australia: Human Research Ethics Committee

Study ID:

TROG 06.02

NCT ID:

NCT00418210

Start Date:

August 2007

Completion Date:

June 2019

Related Keywords:

  • Breast Cancer
  • Accelerated Partial Breast Irradiation
  • Conformal Radiation Therapy
  • Feasibility
  • Early breast cancer
  • Breast Neoplasms

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