Diagnosis of Pathological Complete Response by Vacuum-assisted Biopsy After Neoadjuvant Chemotherapy in Breast Cancer
- Conditions
- Breast Neoplasms
- Interventions
- Device: Vacuum-Assisted Biopsy
- Registration Number
- NCT02948764
- Lead Sponsor
- Heidelberg University
- Brief Summary
The main purpose of the study is to evaluate the potential of a minimal invasive, vacuum-assisted biopsy (VAB) to reliably diagnose a pathological complete response (pCR) in the breast after neoadjuvant chemotherapy (NACT) in breast cancer patients.
The study is designed as a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial, in which we aim to confirm the applicability of preoperative VAB in patients after NACT. Furthermore, we aspire to quantify the rate of concordant pathological findings (pCR yes / no) in biopsy and surgical specimen.
- Detailed Description
In clinical routine surgical treatment follows the pre-operative chemotherapy (NACT). However, recent studies have demonstrated that shrinking tumors need less surgical treatment indicating that patients with pCR could potentially be spared of surgery in the future. However, up to now, prediction of pCR after NACT is only moderately accurate. This prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (MIB) might overcome this diagnostic challenge.
Ultrasound guided VAB will be performed on 600 breast cancer patients after NACT and directly prior to surgery.
There are only two trial visits that are specific to the trial. All other visits will be routine visits.
1. The first trial visit will take place in order to provide the patient with detailed information on the study, its' aims, the VAB procedure, and its risks. The patient will be asked to sign a form of informed consent.
2. At the second trial visit the performance of the VAB (=index test) will take place. This trial visit may vary by patient, tumor, and trial site characteristics and may either be:
1. An ultrasound guided VAB or
2. A stereotactically / mammographically guided VAB. All possible VAB procedures and settings (in outpatient clinic, or in operating room directly before the surgery) are equally accepted. We will allow every trial site to choose the adequate setting to the trial site´s and to their patients' needs.
A visit for a follow up will not be necessary in this setting. Possible complications of the VAB procedure may occur while the biopsy is taken.
The pathological results of the VAB specimen will be generally categorized as follows:
1. Residual tumor cells in VAB specimen (=non-pCR)
2. No residual tumor cells in the VAB specimen and VAB representative of former tumor region (="pCR in VAB")
3. No residual tumor cells in the VAB specimen but VAB unclear or not representative of former tumor region (=possible sampling error). These VABs are categorized as uninformative for the primary endpoint of the clinical trial.
The results will be compared to those of the pathological examination of surgical specimen.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 452
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single-arm study Vacuum-Assisted Biopsy This project is designed as a one-armed diagnostic study. Every patient included in the study will undergo the same diagnostic test, the vacuum-assisted biopsy, after NACT and before surgery according to guidelines.
- Primary Outcome Measures
Name Time Method false negative VAB results, reported as the false negative rate (= FNR) after breast surgery, up to 6 weeks after VAB non-detected residual tumor by VAB (=index test) compared to breast surgery (=reference test): FNR = rate of patients with non-detected residual tumor by VAB compared to breast surgery Residual tumor is defined as a positive result; in surgical specimen as well as in VAB.
- Secondary Outcome Measures
Name Time Method negative predictive value (NPV) after breast surgery, up to 6 weeks after VAB The negative predictive value (NPV) will be calculated as the quotient of the number of cases with pCR in VAB and in surgical specimen (= true negative result), divided by the total number of cases with pCR in VAB.
Residual tumor is defined as a positive result; in surgical specimen as well as in VAB.false positive rate (FPR) after breast surgery, up to 6 weeks after VAB FNR = rate of patients with falsely diagnosed residual tumor by VAB compared to breast surgery Residual tumor is defined as a positive result; in surgical specimen as well as in VAB.
positive predictive value (PPV) after breast surgery, up to 6 weeks after VAB The positive predictive value (PPV) will be calculated as the number of biopsies with detected residual tumor cells in VAB and surgery (= true positive results) divided by the number of all cases with residual tumor cells in the VAB.
Residual tumor is defined as a positive result; in surgical specimen as well as in VAB.
Trial Locations
- Locations (1)
University Breast Unit, Department of Gynecology, University of Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany