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JOURNAL ONKOLOGIE – STUDIE
VISION I

Intelligent Vacuum Assisted Biopsy Immediately Before Surgery as an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer

Rekrutierend

NCT-Nummer:
NCT04289935

Studienbeginn:
August 2020

Letztes Update:
12.01.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Klinik Hirslanden, Zurich

Collaborator:
-

Studienleiter

Christoph Tausch, MD
Study Chair
Brust-Zentrum, Zürich

Kontakt

Studienlocations
(3 von 16)

Alle anzeigen

Studien-Informationen

Detailed Description:

Neoadjuvant chemotherapy (NAC), initially indicated to downstage tumors to achieve the option

of breast conserving surgery, has lately become common practice in the primary treatment of

breast cancer. The use of modern NAC regimens lead to a complete pathologic remission (pCR)

of the tumor in more than 50% in aggressive tumor types.

In general, it is difficult to predict pCR in the absence of invasive surgical techniques, as

it depends on several factors such as biological subtype, the used chemotherapy regimen and

anatomic stage. The most common imaging methods beside clinical examination are breast

ultrasound, mammography and breast magnetic resonance imaging (MRI). As NAC induces different

response patterns, radiologic imaging is not sufficiently accurate in predicting residual

disease. Because of this uncertainty, surgery (and the standardized assessment of resected

tissue) is so far the only valid option to either ascertain complete response or to remove

the complete residual disease.

Vacuum-assisted biopsy (VAB) with the possibility of obtaining tissue of the former tumor

center could contribute more reliably to detect any residual tumor or respectively, rule out

residual disease. Ultrasound (US) or mammographically (MG) guided VAB will be used in this

trial in order to detect residual tumor lesions in patients with radiological complete

response (rCR) after NAC. The investigators will evaluate the diagnostic accuracy of the

post-NAC VAB sample in comparison to the sample obtained in open surgery.

The main objective of the trial is to determine the diagnostic accuracy of I-VAB using the

full pathologic specimen evalutation obtained after open surgery to detect residual tissue.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Written informed consent according to ICH/GCP regulations before registration and

prior to any trial specific procedures

- unifocla, histologically confirmed invasive breast cancer with IHC luminal B (with or

without overexpression or amplification of the HER2 receptor) and all ER negative (ER

< 10%) breast cancers

- Initial tumor size larger than 1 and less than 5 cm (cT1c to cT2), any N, M0

- Clipping of the primary tumor center prior to the start of neo-adjuvant chemotherapy

- Neo-adjuvant chemotherapy resulting in a radiological complete response or near

complete response on MR-Imaging (confirmed within 28 days before or on registration)

as described in the trial specific MR-Imaging instructions (available on the welcome

page of the study specific SecuTrial link)

- Former tumor bed must be accessible for biopsy

- Female or male aged ≥ 18 years

- Adequate condition for breast cancer surgery

- Patients with a previously treated malignancy are eligible, when the risk of the prior

malignancy interfering with either safety or efficacy endpoints is very low

Exclusion criteria:

- Metastatic breast cancer

- Multifocal/Multicentric breast cancer

- Inflammatory breast cancer

- Luminal-A types of breast cancers (ER ≥ 10% and PgR ≥ 10 % and G1 or 2, and/or Ki-67 ≤

20%, HER2 negative) or low risk if assessed by a validated genomic prognostic test

(e.g. Mammaprint, Endopredict, Oncotype or Nanostring)

- Distinct radiological sign of residual disease in the breast after neo-adjuvant

chemotherapy in MRI

- Intra-/peritumoral microcalcifications larger than 2 cm at time of diagnosis

- Any local therapy (irradiation or surgery) to the currently treated breast prior to

the trial intervention

- Contraindication for MRI

- Any other serious underlying medical, psychiatric, psychological, familial or

geographical condition, which in the judgment of the investigator may interfere with

the planned staging, trial intervention and follow-up, affect patient compliance or

place the patient at high risk from trial intervention-related complications

Studien-Rationale

Primary outcome:

1. Sensitivity (Time Frame - max. 6 weeks after registration):
Sensitivity of I-VAB is defined as proportion of true positive patients (Both VAB and surgery showing non pCR) given patients with non pCR assessed using surgical specimen.



Secondary outcome:

1. Specificity (Time Frame - max. 6 weeks after registration):
Specificity of I-VAB is defined as proportion of true negative patients (Both VAB and surgery showing pCR) given patients with pCR assessed using surgical specimen.

2. Positive predictive value (PPV) (Time Frame - max. 6 weeks after registration):
PPV of I-VAB is defined as proportion of true positive patients given patients with non pCR assessed using VAB

3. Negative predictive value (NPV) (Time Frame - max. 6 weeks after registration):
NPV of I-VAB is defined as proportion of true negative patients given patients with pCR assessed using VAB

4. Accuracy (ACC) (Time Frame - max. 6 weeks after registration):
ACC of I-VAB is defined as the proportion of true positive and true negative patients.

5. Surgical lymph node status (Time Frame - max. 6 weeks after registration):
Surgical lymph node status (positive vs. negative) is categorized by the pathologist according to surgical specimen.

6. Adverse events (Time Frame - From US-guided VAB (max. 6 weeks after registration) until 2 weeks after breast surgery (max 1 day after VAB).):
Proportion of patients with bleeding/hematoma causing immediate surgical intervention and breast infection, which are related to VAB.

Geprüfte Regime

  • Vacuum assisted biopsy (VAB):
    The trial intervention consists of a diagnostic interventional procedure, US-guided or mammographically guided VAB post-NAC, prior to the standard breast surgery.

Quelle: ClinicalTrials.gov


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