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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT04437160
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically confirmed invasive adenocarcinoma of the breast.
* Triple negative breast cancer: hormone receptor negative (ER \< 10% and PgR \< 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory.
* Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.
* Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.
* Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.
* Residual invasive disease must be ≥1cm in the breast, and/or have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.
* ECOG Performance Status: 0-1.
* Patients without severe heart, lung, liver and kidney disease.
* Adequate hematologic and end-organ function.
* No more than 6 weeks may elapse between definitive breast surgery and randomization.
Exclusion Criteria:
* Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).
* Previous neoadjuvant chemotherapy with platinum or taxanes alone.
* Patients have received other adjuvant therapy.
* Comprehensive medical examinations have revealed distant metastases before randomization.
* Patients who are not suitable for anthracycline evaluated by investigators.
* Prior history of other malignancy (except carcinoma in situ).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04437160
Study Brief:
Protocol Section:
NCT04437160