Clinical trial for Breast Cancer
Official title Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies
ClinicalTrials.gov ID: NCT07340541
What this study is testing
What is SERD* + abemaciclib?
An investigational combination therapy being studied for advanced estrogen receptor‑positive or triple‑negative metastatic breast cancer. The selective estrogen receptor degrader is designed to bind and promote degradation of the estrogen receptor, while abemaciclib is designed to inhibit CDK4/6 enzymes that drive cell division.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to learn whether using tumor biomarkers to pick standard treatments changes how the cancer behaves.
- Who it's for
- Adults who have metastatic breast cancer that is either estrogen‑receptor‑positive/hormone‑receptor‑negative or triple‑negative.
- What's involved
- Participants will receive the usual care chosen based on their tumor biomarkers, give tumor and blood samples, and have a liquid biopsy (blood test) at the start and before each treatment cycle, plus imaging scans to check the cancer.
- Time commitment
- Treatment continues until the cancer grows, side effects require stopping, or the doctor decides, with doctor visits, blood draws and scans each cycle (about every 3‑4 weeks).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator.
- Age ≥ 18 years of age at the time of consent
- ECOG Performance Status of 0-2 (see APPENDIX A: ECOG Performance Status Scale).
- Patients must fulfill all eligibility criteria outlined in the LCCC2521 Parent Protocol and consented to LCCC2521 Parent Protocol
You likely can't join if
- Inaccessible metastatic lesion to research biopsy
- Subject has already initiated 2nd line therapy
- Concurrent disease or condition that in the opinion of the treating oncologist renders the patient inappropriate for study participation
The study team makes the final eligibility decision.
Where it is enrolling
- New Haven, Connecticut, United States
- Baltimore, Maryland, United States
- Chapel Hill, North Carolina, United States
- Philadelphia, Pennsylvania, United States
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, but 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New Haven, Connecticut, United States; Baltimore, Maryland, United States; Chapel Hill, North Carolina, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.