Breast Cancer Clinical Trial
— NeoBCTOfficial title:
Safety of Breast Conserving Treatment in Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment
Verified date | October 2017 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study explores the safety of breast conserving treatment (BCT)(defined as complete removal of tumor deposits) after neoadjuvant treatment for locally advanced breast cancer.
Status | Terminated |
Enrollment | 18 |
Est. completion date | December 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - Patients with locally advanced breast cancer (cT3-4c, N0-3) with tumors > 5 cm, as determined by MRI, where the present guidelines include them for neoadjuvant systemic therapy - Written informed consent (informed consent document to be approved by the Independent Ethics Committee) prior to study-related procedures and examinations. - Female age > 18 years - Able to comply with the protocol - Histologically confirmed adenocarcinoma of the breast - American Society of Anesthesiologist's physical status category 1 or 2 before surgery. Category 1 and 2 includes healthy patients and patients with only mild systemic disease, whereas category 3 includes patients with more serious systemic diseases (but still operable). Exclusion criteria: - Inflammatory breast cancer or diffuse locoregional involvement of the skin - Stage IV - metastatic disease - Locoregional relapse of earlier breast cancer - Inability (irrespective of reason) to receive the recommended neoadjuvant treatment, - as decided by the treating physician. - American Society of Anesthesiologist's physical status category 4-5 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1 The presence of viable tumor cells at the margins and in the mastectomy specimen after conducted breast preserving resection followed by mastectomy in the same procedure | The surgical specimens will be analysed after surgery, and the results of these analyses will be the basis for the final end point measurements. | 24 weeks after start of neoadjuvant treatment (at surgery) | |
Secondary | Tumor molecular marker characteristics related to complete resection by BCT | Tumor molecular marker characteristics, MRI, mammography (Mx) and ultrasound (US) results and clinical parameters in patients with residual tumor cells in the mastectomy specimen compared to those with no tumor cells | 24 weeks after start of neoadjuvant treatment (at surgery) |
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