Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT04289935
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04289935
Study Brief:
Protocol Section:
NCT04289935