Invasive Mammary CarcinomaPhase 2INSIGHTNCT05693766
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
A Phase 2 study testing Capecitabine, Endocrine-therapy and MammoPrint ® and BluePrint assays in people with Invasive Mammary Carcinoma and Metastatic Breast Cancer, run by Sonya Reid at 4 sites in United States.
Trial summary
This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Mammary Carcinoma, Metastatic Breast Cancer
- What is being tested?
- Capecitabine, Endocrine-therapy and MammoPrint ® and BluePrint assays
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Sep 2023to 31 Aug 2037
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 19Show fewer
- 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 lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation)
- Patients with bone only disease allowed if possible to evaluate on radiological exams (eg.bone scan, PET/CT, CT, MRI) even if lesions are non-measurable according to RECIST1.1.
- Adequate organ function including:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
- Platelets ≥ 100 × 10^9/L
- Hemoglobin ≥ 8/g/dL (may have been transfused)
- Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present)
- Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50mL/min as calculated using the Cockcroft-Gault (CG) equation
- For randomized patients only: tumors must be diagnosed as non-Luminal A using the Blueprint® and Mammaprint® tests
Who cannot join
- Prior chemotherapy in the metastatic setting
- Previous malignant disease other than breast cancer within the last 2 years with associated competing risk, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk cancers considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of study drugs AND additional therapy not required while receiving study treatment).
- Persisting symptoms related to prior therapy that has not reduced to Grade 1 [National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0]; however, menopausal symptoms, alopecia, and sensory neuropathy Grade ≤ 2 is acceptable
- Pregnant or breastfeeding females.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Alabama Birmingham
Birmingham, Alabama, 35249
Kyndall Thomas
Nusrat Jahan
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Vanderbilt-Ingram Services for Timely Access, 800-811-8480
Heather McArthur, MD, PhD
- Recruiting
West Cancer Center (Margaret West Comprehensive Breast Center)
Memphis, Tennessee, 38138
Sonia Benn, MD, sbenn@westclinic.com
Sonia Benn
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Vanderbilt-Ingram Service for Timely Access, 800-811-8480, cip@vumc.org
Sonya Reid, MD
About this study
Official title: Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)
This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)
Read the detailed description
Primary Objective:
- Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer
Secondary Objectives:
- Compare the safety and tolerability of capecitabine versus endocrine therapy in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer
- Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer
Correlatives:
- Determine if the tumor mutations detected in cfDNA are early surrogates of response
- Determine if the cfDNA results at disease progression show new genomic alterations potentially associated with resistance to therapy
- Being tested
- Capecitabine, Endocrine-therapy, MammoPrint ® and BluePrint assays
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
2000 mg taken by mouth twice daily for 7 days on, 7 days off
Endocrine-therapyOther
Endocrine therapy administered
MammoPrint ® and BluePrint assaysOther
Archival tissue will be analyzed using the MammoPrint ® and BluePrint assays
| Study group | Role | What they receive |
|---|---|---|
| Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes | Active comparator | Not described Receives: Other: Endocrine-therapy; Other: MammoPrint ® and BluePrint assays |
| Capecitabine_Non-Luminal A subtypes | Experimental | Not described Receives: Drug: Capecitabine; Other: MammoPrint ® and BluePrint assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: Up to 3 years
Secondary outcomes (7)
Overall survival at 2 years
Measured: Up to 2 years
Overall survival at 5 years
Measured: Up to 5 years
Overall survival at 10 years
Measured: Up to 10 years
Clinical Benefit Rate
Percentage of patients without disease progression at 6 months
Measured: Approximately 6 months
Overall response rate
Measured: Up to 3 years
Incidence of adverse events
Measured: Up to 28 days post-treatment
Overall impact of treatment toxicity
Will be measured using Functional Assessment of Cancer Therapy (FACT)-G (5 point Likert-type scale from 1 ("none at all") to 5 ("very much")
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start28 Sep 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Mammary CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonya Reid
- Sponsor type
- University, hospital or other
- Collaborators
- Agendia, Susan G. Komen Breast Cancer Foundation
- Responsible party
- Sponsor-investigator, Sonya Reid, Vanderbilt-Ingram Cancer Center
- Investigators
- Sonya Reid, MD, Principal investigator, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693766
- Sponsor's protocol ID
- VICCBRE2256
- Acronym
- INSIGHT
- Status last verified
- Aug 2026
- First submitted
- 11 Jan 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)
- ClinicalTrials.gov ID
- NCT05693766
- Acronym / sponsor ID
- INSIGHT / VICCBRE2256
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Sonya ReidUniversity, hospital or other
- Collaborators
- Agendia, Susan G. Komen Breast Cancer Foundation
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2037 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)
Detailed description
Primary Objective:
- Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer
Secondary Objectives:
- Compare the safety and tolerability of capecitabine versus endocrine therapy in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer
- Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer
Correlatives:
- Determine if the tumor mutations detected in cfDNA are early surrogates of response
- Determine if the cfDNA results at disease progression show new genomic alterations potentially associated with resistance to therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes | Active comparator | Other: Endocrine-therapy, Other: MammoPrint ® and BluePrint assays |
| Capecitabine_Non-Luminal A subtypes | Experimental | Drug: Capecitabine, Other: MammoPrint ® and BluePrint assays |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
- Previously exposed to an aromatase inhibitor (AI) or a selective estrogenreceptor modulator/ downregulator (SERM; SERD) + a CDK4/6 inhibitor.
Key exclusion criteria (4 listed)
- Prior chemotherapy in the metastatic setting
- Previous malignant disease other than breast cancer within the last 2 years with associated competing risk, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk cancers considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of study drugs AND additional therapy not required while receiving study treatment).
- Persisting symptoms related to prior therapy that has not reduced to Grade 1 [National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0]; however, menopausal symptoms, alopecia, and sensory neuropathy Grade ≤ 2 is acceptable
- Pregnant or breastfeeding females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine2000 mg taken by mouth twice daily for 7 days on, 7 days off | Drug | Capecitabine_Non-Luminal A subtypes |
| Endocrine-therapyEndocrine therapy administered | Other | Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes |
| MammoPrint ® and BluePrint assaysArchival tissue will be analyzed using the MammoPrint ® and BluePrint assays | Other | Capecitabine_Non-Luminal A subtypes, Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes |
Primary outcome
Progression free survival
Time frame: Up to 3 years
7 secondary outcomes
Overall survival at 2 years
Time frame: Up to 2 years
Overall survival at 5 years
Time frame: Up to 5 years
Overall survival at 10 years
Time frame: Up to 10 years
Clinical Benefit Rate
Time frame: Approximately 6 months
Overall response rate
Time frame: Up to 3 years
Incidence of adverse events
Time frame: Up to 28 days post-treatment
Overall impact of treatment toxicity
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sonya Reid, MD principal investigator
Vanderbilt University/Ingram Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine, Endocrine-therapy and MammoPrint ® and BluePrint assays in people with Invasive Mammary Carcinoma and Metastatic Breast Cancer, run by Sonya Reid at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanderbilt-Ingram Services for Timely Access (800-811-8480, cip@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.