Testing gene signatures to guide hormone-positive metastatic breast cancer treatment
Tests capecitabine chemotherapy in adults with hormone-positive metastatic breast cancer not Luminal A.
Plain-language title generated from the registry record
Registry title: Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Key facts
- Where
- Birmingham, Dallas, Memphis, and Nashville, United StatesSee the 4 sites
- Phase
- Phase 2
Where in United States
- University of Alabama BirminghamBirmingham, United StatesTaking people
- UT Southwestern Medical CenterDallas, United StatesTaking people
- West Cancer Center (Margaret West Comprehensive Breast Center)Memphis, United StatesTaking people
- Vanderbilt University/Ingram Cancer CenterNashville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sonya Reid
- Trial code
- NCT05693766
- Record updated
- 6 November 2026
- Original description
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 full original descriptionShow less
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)
Inclusion: 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 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.
Exclusion: Prior chemotherapy in the metastatic setting; 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; 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); Pregnant or breastfeeding females.