Status:
RECRUITING
Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer
Lead Sponsor:
Klinik Hirslanden, Zurich
Collaborating Sponsors:
Oncoplastic Breast Consortium (OPBC)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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. A...
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....
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- 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 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
Exclusion
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04289935
Start Date
August 17 2020
End Date
June 1 2025
Last Update
October 23 2024
Active Locations (26)
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1
Universitätsspital Salzburg
Salzburg, Austria, 5020
2
Brustzentrum Schwaz
Schwaz, Austria, 6130
3
St. Josef Krankenhaus Wien
Vienna, Austria, 1130
4
Agaplesion Markus Krankenhaus
Frankfurt, Germany, 60431