NCT05693766 · Sonya Reid
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
(INSIGHT)
What this study is about
This is an where both patients and doctors know the treatment given, conducted at multiple hospitals, two-treatment group$1 Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e.
View original scientific description
This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e.
Interventions
DRUG
Capecitabine
2000 mg taken by mouth twice daily for 7 days on, 7 days off
OTHER
Endocrine-therapy
Endocrine therapy administered
OTHER
MammoPrint ® and BluePrint assays
Archival tissue will be analyzed using the MammoPrint ® and BluePrint assays
Primary outcome measures
Progression free survival
Time frame: Up to 3 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Signed and dated written informed consent.
- Subjects ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is:
- ER (\>/=1%) and/or PR (\>/= 1%) by IHC and HER2 negative (by IHC or FISH)
- Previously exposed to an aromatase inhibitor (AI) or a selective estrogenreceptor modulator/ downregulator (SERM; SERD) + a CDK4/6 inhibitor.
- Prior radiation permitted (if completed at least 2 weeks prior to study entry. Patients who have received prior radiotherapy must have recovered from toxicity (≤ grade 1) induced by this treatment (except for alopecia)
- Patients with brain metastasis secondary to breast cancer and clinically stable for more than 4 weeks from completion of radiation treatment and off steroids
- Evaluable disease (measurable or non-measurable)
- Measurable disease, ie, at least 1 measurable l
Where
- Birmingham, Alabama
- Nashville, Tennessee
- Dallas, Texas
Collaborators
Agendia, Susan G. Komen Breast Cancer Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 20, 2026 · Source of record for eligibility and locations