ACTRN12613000551796
Recruiting
Phase 2
In women diagnosed with localised breast cancer, does Accelerated Partial Breast Irradiation (APBI) demonstrate acceptable general cosmesis with an improved quality of life?
Dr Yaw Chin.0 sites60 target enrollmentMay 16, 2013
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr Yaw Chin.
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Too much, too soon? The impact of treatment-focused genetic testing in patients newly diagnosed with breast cancer.early or locally advanced breast cancerWomen at increased risk for carrying a faulty gene for breast and/or ovarian cancerCancer - BreastHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersACTRN12610000502033Prince of Wales Hospital120
Completed
Phase 3
Clinically node negative breast cancer patients undergoing breast conserving therapy: Sentinel lymph node procedure versus follow-up. A Dutch randomized controlled multicentre trial.breast cancersentinel lymph node metastasessentinel lymph nodes1000629110006295NL-OMON54499Medisch Universitair Ziekenhuis Maastricht1,730
Recruiting
Not Applicable
Clinically node negative breast cancer patients undergoing breast conserving therapy: Sentinel lymph node procedure versus follow-up (BOOG 2013-08).breast neoplasmsbreast cancersentinel lymph node biopsybreast conserving therapy.NL-OMON28389KWF, CZ, ZonMw1,644
Active, not recruiting
Phase 1
Pivotal study in breast cancer patients investigating efficacy and safety of LA-EP2006 and Neulasta®Breast CancerTherapeutic area: Diseases [C] - Cancer [C04]EUCTR2012-002039-28-ESSandoz GmbH308
Completed
Phase 3
A study to evaluate the Efficacy and Safety of LA-EP2006 and Neulasta® in patients with breast cancer.CTRI/2012/10/003065Sandoz GmbH302