Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSonya Reid
About this trial
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)
Eligibility criteria
Qualifiers
Signed and dated written informed consent.
Subjects ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
ER (>/=1%) and/or PR (>/= 1%) by IHC and HER2 negative (by IHC or FISH)
Disqualifiers
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 design
Treatments tested in this trial
- Capecitabine
- Endocrine-therapy
- MammoPrint ® and BluePrint assays
Treatment groups
64 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sonya Reid
Lead sponsor
Vanderbilt-Ingram Cancer Center
Sponsor institution
Agendia
Collaborator
Susan G. Komen Breast Cancer Foundation
Collaborator
Source ClinicalTrials.gov