Our study aim is to assess whether it is feasible to remove small breast cancers completely using VAB under US guidance.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is the frequency of successful complete tumour
excision by the VAB, where successful is defined as *having tumour free
margins, and no residual (in situ) cancer in the surgical specimen'.
Secondary outcome
- Whether we can predict successful complete resection of the tumor based on
imaging features other than size.
- Whether we can predict successful complete resection of the tumor based upon
histopathological features from the large core biopsy specimens.
- To analyze the characteristics of eventual residual tumor deposits in the
surgical specimens.
- To explore SN status following VAB of the primary tumor.
- Analyze the difference in quality-of-life and pain experience between VAB
excision and surgery.
Background summary
Breast cancer is the most frequently diagnosed cancer in women worldwide. Each
year more than 130000 women with breast cancer are treated in the Netherlands.
The national screening program has reduced the average size of breast cancers.
Small breast cancers are nowadays generally treated with lumpectomy. While this
approach works well it results in disfiguring scars to the breast, and nearly
always more tissue is removed than strictly necessary.
VAB, introduced in 1995, has been proven as a very reliable biopsy tool for the
assessment of breast lsions. The VAB system removes multiple larger tissue
samples through a very small skin incision under US guidance.
Study objective
Our study aim is to assess whether it is feasible to remove small breast
cancers completely using VAB under US guidance.
Study design
In 210 women with cancers <=15 mm based upon US and MRI measurements, and
without mammographic evidence of more extensive disease (e.g.
microcalcifications) the patient is eligible. Patients will be asked to fill
out a questionnaire for assessment of breast cancer risk, using the
Tyrer-Cuzick (or IBIS) model.
First, the tumor will be removed under local anesthesia using the VAB system
with US guidance, through a small skin incision (<0.5 cm). A localization
marker will be placed in the biopsy cavity, to help determine the cavity
location. After 3 weeks, the breast conserving surgery is performed, excising
the VAB excision cavity and a >=1 cm of surrounding tissue, as deemed
appropriate by the attending breast surgeon. A sentinel node biopsy will be
performed in the same procedure.
Study burden and risks
While there is no direct benefit nor detrimental effect from this study to the
patients participating, the study has large implications for many women, as
breast cancer remains the most common cancer in women, and due to screening,
most cancers are small. Further reduction of the impact of local treatment is
still desired as the psychosocial and somatic effects of breast deformation can
be substantial.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1. Female sex.
2. 18 years or older.
3. US visible breast cancer.
4. Histologically proven non-lobular invasive breast carcinoma with maximum
diameter of 15 mm as assessed by US.
5. Willing and able to undergo preoperative breast MRI
6. Able to fill out the questionnaire
7. Able to provide informed consent.
Exclusion criteria
1. Male sex.
2. 17 years or younger.
3. No proven invasive breast cancer.
4. Poor US visibility of the breast cancer.
5. Neoadjuvant therapy.
6. Contra-indications to breast MRI or intravenous contrast administration.
7. Unable to fill out the questionnaire
8. Unable to provide informed consent.
9. Patients with breast implants.
10. Pregnancy.
11. Presence of ipsilateral lesions on MRI.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68820.091.19 |