BridgeMD
Improved breast cancer therapy (I-BCT-1) in the neoadjuvant and metastatic setting: A phase 2 clinical trial protocol studying biological rationale for the optimal selection of treatment regimens
EU CTIS ID: 2024-515087-31-00
What this study is testing
To determine the genomic (DNA) state and changes over time in the tumors; the genetic characteristics and changes in the tumors will be evaluated by analyses of tumor samples taken before, under (if possible) and after the scheduled treatment period using DNA analyses (including whole genome SNP and methylation analyses or whole genome sequencing).
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically or cytologically confirmed, HER2-negative, men or women with breast adenocarcinoma with radiologic measureable disease (>20 mm) and Ki67 labeling index ≥ 20% in patients with T2 tumor and ≥ 15% in patients with T3 or T4 tumors.
- WHO performance status ≤ 2
- Adequate hematological function : Absolute neutrophil count (ANC) ≥1.0 x 109/L and Platelet count ≥100 x 109/L and Hemoglobin ≥10 g/dL (may be transfused to maintain or exceed this level)
- Adequate liver function: Total bilirubin <1.5 x upper limit of normal (ULN) and AST, ALT <2.5 x ULN (in cohort I) and AST, ALT <5 x ULN (in cohort II)
- Adequate renal function: Serum creatinine ≤1.25 x ULN (and if measured: Creatinine clearance within normal reference values).
You likely can't join if
- Previous chemotherapy treatment for localized breast cancer less than 24 months before inclusion into study (cohort I) or metastatic breast cancer treated with taxane (cohort II).
- Other earlier or concomitant carcinoma less than five years prior to the breast cancer diagnosis, except for BCC, in situ cervix cancer or breast cancer.
- Treatment with any other investigational agent, or participation in another clinical intervention trial within 21 days prior to enrolment.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.