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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT05179304
Eligibility Criteria:
Inclusion Criteria:
* Signed the informed consent.
* Female aged between 18 and 70 years.
* Pathologically diagnosed operable breast cancer.
* WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Cancer located in the upper inner quadrant; Single tumor or multiple tumors in the same quadrant.
* The important organ functions meet the following criteria:
* WBC \>=3.0 x 10\^9/L; Neutrophilic granulocytes \>=1.5×10\^9/L; Platelet \>=100 x 10\^9/L; Hb \>=9 g/dL;
* Total bilirubin no more than 1.5 times the normal upper limit (ULN); AST and ALT no more than 1.5 times ULN; AKP no more than 2.5 times ULN;
* Serum creatinine no more than 1.5 times ULN or Clearance rate of creatinine \>= 60ml/min;
* Thyroid stimulating hormone (TSH) \<= ULN (T3, T4 levels need to be detected simultaneously if abnormalities, the patient can be included if T3, T4 levels is normal);
* LVEF basement \>= 50%.
* Adjust to the criteria of breast conserving surgery.
Exclusion Criteria:
* Multifocal or multicentric disease.
* Tumor localized in the central quadrant or the distance to the nipple \< 2 cm；
* Diffused calcifications with fine plemorphic or fine linear or fine-linear branching morphology.
* The ratio of tumor to breast \> 20%;
* The diameter of tumor is up to 4 cm;
* Women in the early or intermediate stage of pregnancy;
* Prior history of breast radiation;
* Any severe comorbidities, inability to give informed consent or unavailability for follow-up.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05179304
Study Brief:
Protocol Section:
NCT05179304