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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT05747794
Eligibility Criteria:
Inclusion Criteria:
* Metastatic HR+ positive (estrogen receptor positive and/or progesterone receptor positive) or hormone receptor negative (HR˗), and HER2-neg breast adenocarcinoma, histologically proven by biopsy on the last available tumor tissue
* Participants with HR+ metastatic breast cancer (MBC) who progressed on or after ≥1 line of endocrine based therapy and are indicated to receive chemotherapy for metastatic disease
* Participants with HR- MBC (i.e. triple-negative breast cancer \[TNBC\]) who are indicated to receive paclitaxel chemotherapy without PD 1/PD-L1 therapy in the 1st line setting for metastatic disease
* ECOG performance status 0-1
* Expected survival longer than three months
Exclusion Criteria:
* Prior chemotherapy for metastatic breast adenocarcinoma
* Participants with HR+ MBC who have received \<1 line of ET based therapy in the metastatic setting
* Participants with HR+ MBC who are not primary or secondary resistant to ET-based therapy and would be candidates to ET based therapy as per applicable treatment guidelines
* TNBC participants who are candidates for PD-1/PD-L1 therapy in combination with chemotherapy
* Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05747794
Study Brief:
Protocol Section:
NCT05747794