To assess whether core biopsies of the breast after neoadjuvant chemotherapy can reliably predict a pathologic complete response. We will therefore calculate the sensitivity, specificity, positive predictive value and negative predictive value of…
ID
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is specificity of post-NST biopsies of the breast in
assessing the presence of pCR after NST. Secondary endpoints are the
false-negative rate, negative and positive predictive value and sensitivity of
the biopsies.
Secondary outcome
- A secondary endpoint is to identify patient groups in which presence or
absence of a pathologic complete response can be reliably predicted following
neoadjuvant chemotherapy by imaging methods and/or post-NAC biopsies.
- Another secondary endpoint is to evaluate how many biopsies would be required
to correctly assess the presence of a pathologic complete response.
Background summary
Over 60% of the women who are diagnosed with breast cancer in the Netherlands
are treated with chemotherapy, which may be administered before (neoadjuvant
chemotherapy or NAC) or after (adjuvant) locoregional treatment. Depending on
the subtype, 10-75% of patients will have a pathologic complete response (pCR)
after NAC. In this target group, surgery of the breast could be omitted, if
post-NAC-biopsies, combined with data on imaging and pathology, can reliably
predict a pCR. Consequently, overtreatment of the breast is prevented and
morbidity is minimized.
Study objective
To assess whether core biopsies of the breast after neoadjuvant chemotherapy
can reliably predict a pathologic complete response. We will therefore
calculate the sensitivity, specificity, positive predictive value and negative
predictive value of post-NAC biopsies of the breast in assessing the presence
of a pCR.
We aim to develop a decision tree to guide clinical decisions on local
treatment in breast cancer patients treated with NAC.
For treatment of the breast this decision tree will define two patient groups:
- Presence or residual disease (no-pCR) can be reliably predicted without
performing core biopsies and conventional breast surgery is indicated
- Presence of pCR needs to be assesses by core biopsies, and surgery may be
omitted if biopsies show no residual tumour
Study design
A marker is placed in the centre of the tumor in all patients. After completion
of NST, a total of eight 14G core biopsies are obtained at various distances
form the iodine seed (4 central and 4 peripheral). Preferably, biopsies are
obtained (ultra-sound guided) in the operating room while the patient is under
general anaesthesia, just before surgery. Immediately hereafter, the
pre-planned surgical resection of the area surrounding the marker is performed.
In participating hospitals where it is not possible to obtain biopsies in the
operating room due to logistic reasons, biopsies may be obtained in the
outpatient clinic under ultrasound or stereotactic guidance.
Pathology results of biopsy material and surgical specimen will be compared.
This allows us to establish the biopsy location and minimum number of biopsies
per patient required to accurately assess pCR. Pathology results of the
biopsies will be compared with data on imaging, patient and tumour
characteristics. A pCR is defined as no residual tumour cells seen at
microscopy.
Study burden and risks
Participation in this study will involve 8 extra biopsies. When biopsies are
obtained in the operating room while the patients is already under anaesthesia,
we do not expect any burden or risks. Operation time will be prolonged with
approximately 20 minutes.
When the extra biopsies are obtained in the outpatient clinic, extra burden for
the patient may consist of discomfort during and following the biopsy
procedure. Biopsies obtained in the outpatient clinic will be obtained under
local anaesthesia If possible, a pre-existing biopsy scar will be used in order
to minimize the number of biopsy scars.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- Age * 18 years
- Primary breast cancer, any T-stage, any N-stage
- Invasive carcinoma of the breast
- Tumour histology and receptor status established by pre-NST core biopsy
- Neoadjuvant systemic therapy (with at least 1 regime of chemotherapy)
- MRI performed prior to NST
- MRI scan after NST showed radiologic complete or partial response (0.1 * 2.0 cm contrast enhancement, *30% decrease in tumor size, according to RECIST 1.1 criteria) on MRI*
- Correct position of the marker at the center of the original tumour bed
- Written and signed informed consent;* NB: When a patient showed radiologic complete response on MRI before the last course of NST and the patient does not wish to undergo an additional MRI after NST, the patient may be included in the MICRA trial. When a patient showed partial response on MRI before the last course of NST and the patient does not wish to undergo additional MRI after NST, the patient may NOT be included in the MICRA trial.
Exclusion criteria
- Contra-indications for MR imaging
- Ductal carcinoma in situ as shown by core biopsy pre-NST
- Distant metastatic disease
- Prior radiotherapy or surgery of the ipsilateral breast
Design
Recruitment
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 | NL56181.031.15 |