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

NCT04289935 | Recruiting DMC

• 1 other identifier: HIRSLANDEN 01 OPBC SAKK 23/18
• Study Type: interventional
• Target: 420
• Locations: 4 countries
• Sites: 26

Brief Summary

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  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.

  max. 6 weeks after registration

Secondary Outcomes (6)

• Specificity

  max. 6 weeks after registration

• Positive predictive value (PPV)

  max. 6 weeks after registration

• Negative predictive value (NPV)

  max. 6 weeks after registration

• Accuracy (ACC)

  max. 6 weeks after registration

• Surgical lymph node status

  max. 6 weeks after registration

Study Arms (1)

single arm

EXPERIMENTAL

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

Procedure: Vacuum assisted biopsy (VAB)

Interventions

Vacuum assisted biopsy (VAB) PROCEDURE

The trial intervention consists of a diagnostic interventional procedure, US-guided or mammographically guided VAB post-NAC, prior to the standard breast surgery.

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
• unifocal, 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). MRI is strongly recommended, alternative ultrasound
• 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

You may not qualify if:

• 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 by imaging
• 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
• 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

Sponsors & Collaborators

• Klinik Hirslanden, Zurich: lead
• Oncoplastic Breast Consortium (OPBC): collaborator

Study Sites (26)

Universitätsspital Salzburg

Salzburg, 5020, Austria

NOT YET RECRUITING

Brustzentrum Schwaz

Schwaz, 6130, Austria

RECRUITING

St. Josef Krankenhaus Wien

Vienna, 1130, Austria

RECRUITING

Agaplesion Markus Krankenhaus

Frankfurt, 60431, Germany

RECRUITING

Brustzentrum Heidelberg

Heidelberg, 69121, Germany

RECRUITING

UFK Klinikum Südstadt Rostock

Rostock, 18059, Germany

RECRUITING

Helios Universitätsklinikum Wuppertal

Wuppertal, 42283, Germany

RECRUITING

Tumor Zentrum Aarau

Aarau, 5000, Switzerland

RECRUITING

Kantonsspital Baden

Baden, 5404, Switzerland

RECRUITING

Universitätsspital Basel

Basel, 4031, Switzerland

RECRUITING

Bethesda Spital

Basel, 4052, Switzerland

RECRUITING

St. Claraspital

Basel, Switzerland

RECRUITING

Hirslanden Brustzentrum Bern Biel

Bern, 3013, Switzerland

RECRUITING

Kantonsspital Graubünden

Chur, 7000, Switzerland

RECRUITING

Spital Thurgau AG Frauenfeld und Münsterlingen

Frauenfeld, 8501, Switzerland

RECRUITING

Clinique de Genolier

Genolier, 1272, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

RECRUITING

Hirslanden Klinik St. Anna

Lucerne, 6006, Switzerland

RECRUITING

Ente Ospedaliero Cantonale, Dipartimento di ginecologia e ostretricia

Lugano, 6962, Switzerland

RECRUITING

Brustzentrum Rheinfelden

Rheinfelden, 4310, Switzerland

RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Tumor- und BrustZentrum Ostschweiz

Sankt Gallen, 9016, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

RECRUITING

Brust-Zentrum Seefeld

Zurich, 8008, Switzerland

RECRUITING

Universitäts Spital Zürich

Zurich, 8091, Switzerland

RECRUITING

Mediclinic City Hospital Dubai

Dubai, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christoph Tausch, MD

  Brust-Zentrum, Zürich

  STUDY CHAIR

Central Study Contacts

Daniel Tschopp

CONTACT

+41 44 387 9545; daniel.tschopp@hirslanden.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: multicenter, prospective, single arm, feasibility trial

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 28, 2020
• Study Start: August 17, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

AU (3); CH (18); DE (4); AE (1)