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

NCT04289935

Description:

Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery 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.

Related Conditions:
  • Invasive Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT04289935

Trial Eligibility

Document

Title

  • Brief Title: Vacuum Assisted Biopsy Immediately Before Surgery as an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer
  • Official Title: Vacuum Assisted Biopsy Immediately Before Surgery as an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer (VISION I): A Multicenter Prospective Feasibility Trial

Clinical Trial IDs

  • ORG STUDY ID: SAKK 23/18
  • NCT ID: NCT04289935

Conditions

  • Breast Cancer

Purpose

Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery 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.

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 the post-NAC VAB
      in determining pCR compared to open surgery.

Trial Arms

NameTypeDescriptionInterventions
single armExperimentalUnicentric histologically confirmed invasive luminal B, HER2- enriched, triple negative breast cancer + Clipping + Neoadjuvant chemotherapy rCR / near-rCR in MRI Registration US-guided VAB Breast conserving surgery / mastectomy Pathology examination 1. Preoperative VAB, 2. Surgical specimen

    Eligibility Criteria

            Inclusion Criteria:

          -  Written informed consent according to ICH/GCP regulations before registration and
             prior to any trial specific procedures

          -  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 SAKK
             portal

          -  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
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Sensitivity
    Time Frame:max. 6 weeks after registration
    Safety Issue:
    Description:Sensitivity 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 Measures

    Measure:Specificity
    Time Frame:max. 6 weeks after registration
    Safety Issue:
    Description:Specificity is defined as proportion of true negative patients (Both VAB and surgery showing pCR) given patients with pCR assessed using surgical specimen.
    Measure:Positive predictive value (PPV)
    Time Frame:max. 6 weeks after registration
    Safety Issue:
    Description:PPV is defined as proportion of true positive patients given patients with non pCR assessed using VAB
    Measure:Negative predictive value (NPV)
    Time Frame:max. 6 weeks after registration
    Safety Issue:
    Description:NPV is defined as proportion of true negative patients given patients with pCR assessed using VAB
    Measure:Accuracy (ACC)
    Time Frame:max. 6 weeks after registration
    Safety Issue:
    Description:ACC is defined as the proportion of true positive and true negative patients.
    Measure:Surgical lymph node status
    Time Frame:max. 6 weeks after registration
    Safety Issue:
    Description:Surgical lymph node status (positive vs. negative) is categorized by the pathologist according to surgical specimen.
    Measure:Adverse events
    Time Frame:From US-guided VAB (max. 6 weeks after registration) until 2 weeks after breast surgery (max 1 day after VAB).
    Safety Issue:
    Description:Proportion of patients with bleeding/hematoma causing immediate surgical intervention and breast infection, which are related to VAB.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Active, not recruiting
    Lead Sponsor:Swiss Group for Clinical Cancer Research

    Trial Keywords

    • Neoadjuvant chemotherapy
    • VISION I
    • breast cancer
    • Vacuum assisted biopsy

    Last Updated

    May 26, 2021