TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)
Biomarker-driven breast cancer trial testing new therapies
Plain English Summary
Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies is a Phase 2 clinical trial sponsored by UNC Lineberger Comprehensive Cancer Center studying Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-positive Breast Cancer, Hormone Receptor Negative Breast Carcinoma. This trial tests new treatments for advanced breast cancer based on specific tumor biomarkers. It is for patients with estrogen receptor-positive/hormone receptor-negative or triple-negative metastatic breast cancer. Participation involves providing tumor tissue and blood samples, and receiving standard of care therapy guided by biomarkers. Alternatives include other standard breast cancer treatments not part of this specific trial. The trial aims to enroll 700 participants.
Official Summary
This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive/hormone receptor-negative (ER+/HR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients aged 18 or older with metastatic breast cancer who have not started second-line therapy. Must have a tumor that can be biopsied for biomarker testing. Patients with other serious health conditions that could interfere with treatment may not be eligible. This trial is studying Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-positive Breast Cancer, Hormone Receptor Negative Breast Carcinoma, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how long patients live without their cancer getting worse, helping to understand how effective the new biomarker-directed therapies are. The specific primary outcome measures are: Intra-Individual Progression-Free Survival (PFS) (Up to 5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial aims to fill a treatment gap by personalizing advanced breast cancer therapy based on individual tumor biomarkers, potentially leading to more effective treatments. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-positive Breast Cancer, Hormone Receptor Negative Breast Carcinoma, where improved treatment options are needed.
Investor Insight
This trial explores biomarker-driven approaches in a large cancer market, with potential for improved outcomes and competitive advantage if successful. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval. The large enrollment target of 700 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if your specific breast cancer type and biomarkers make you eligible for this trial. Be prepared for regular clinic visits for treatment, imaging scans, and blood draws. Understand that treatment will continue until your cancer progresses, you experience severe side effects, or your doctor decides to stop. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 700 participants
Interventions
- DRUG: SERD* + abemaciclib — Investigators choice Selective Estrogen Receptor Degrader + abemaciclib therapy.
- DRUG: SERD* + everolimus — Investigators choice Selective Estrogen Receptor Degrader + everolimus therapy.
- DRUG: SERD* + everolimus or capecitabine — Investigators choice Selective Estrogen Receptor Degrader + everolimus or capecitabine therapy.
- DRUG: SOC — standard-of-care (SOC) chemotherapy in breast cancer
- DRUG: Antiandrogen — Antiandrogen therapy
Primary Outcomes
- Intra-Individual Progression-Free Survival (PFS) (Up to 5 years)
Secondary Outcomes
- Progression free survival (PFS) - Between-Arm Evaluation (Up to 3 months)
- Tissue- and blood-based biomarkers on response rate (Up to 3 months)
- Overall survival (OS) (Up to 12 months)
- Objective response rate (ORR) (Up to 3 months)
- Duration of response (DoR) (Up to 12 months)
Full Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Trial Locations
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Frequently Asked Questions
What is clinical trial NCT07340541?
NCT07340541 is a Phase 2 INTERVENTIONAL study titled "Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies." It is currently not yet recruiting and is sponsored by UNC Lineberger Comprehensive Cancer Center. The trial targets enrollment of 700 participants.
What conditions does NCT07340541 study?
This trial investigates treatments for Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-positive Breast Cancer, Hormone Receptor Negative Breast Carcinoma. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT07340541?
The interventions being studied include: SERD* + abemaciclib (DRUG), SERD* + everolimus (DRUG), SERD* + everolimus or capecitabine (DRUG), SOC (DRUG), Antiandrogen (DRUG). Investigators choice Selective Estrogen Receptor Degrader + abemaciclib therapy.
What does Phase 2 mean for NCT07340541?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07340541?
This trial is currently "Not Yet Recruiting." It started on 2026-02. The estimated completion date is 2031-06-02.
Who is sponsoring NCT07340541?
NCT07340541 is sponsored by UNC Lineberger Comprehensive Cancer Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07340541?
The trial aims to enroll 700 participants. The trial has not yet started recruiting.
How is NCT07340541 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07340541?
The primary outcome measures are: Intra-Individual Progression-Free Survival (PFS) (Up to 5 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07340541 being conducted?
This trial is being conducted at 1 site, including Chapel Hill, North Carolina (United States).
Where can I find official information about NCT07340541?
The official record for NCT07340541 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07340541. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07340541 testing in simple terms?
This trial tests new treatments for advanced breast cancer based on specific tumor biomarkers. It is for patients with estrogen receptor-positive/hormone receptor-negative or triple-negative metastatic breast cancer.
Why is this trial significant?
This trial aims to fill a treatment gap by personalizing advanced breast cancer therapy based on individual tumor biomarkers, potentially leading to more effective treatments.
What are the potential risks of participating in NCT07340541?
Potential side effects depend on the specific treatments received but can include fatigue, nausea, and changes in blood counts. There is a risk that the tumor may not be accessible for the required biopsy. The chosen therapies may not be effective for everyone, and cancer progression is a possibility. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07340541?
Ask your doctor if your specific breast cancer type and biomarkers make you eligible for this trial. Be prepared for regular clinic visits for treatment, imaging scans, and blood draws. Understand that treatment will continue until your cancer progresses, you experience severe side effects, or your doctor decides to stop. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07340541 signal from an investment perspective?
This trial explores biomarker-driven approaches in a large cancer market, with potential for improved outcomes and competitive advantage if successful. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participation involves providing tumor tissue and blood samples, and receiving standard of care therapy guided by biomarkers. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.