Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort

NCT05693766 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: VICCBRE2256
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief 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)

Conditions

Invasive Mammary Carcinoma; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Up to 3 years

Secondary Outcomes (7)

• Overall survival at 2 years

  Up to 2 years

• Overall survival at 5 years

  Up to 5 years

• Overall survival at 10 years

  Up to 10 years

• Clinical Benefit Rate

  Approximately 6 months

• Overall response rate

  Up to 3 years

Study Arms (2)

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

Interventions

Capecitabine DRUG

2000 mg taken by mouth twice daily for 7 days on, 7 days off

Capecitabine_Non-Luminal A subtypes

Endocrine-therapy OTHER

Endocrine therapy administered

Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes

MammoPrint ® and BluePrint assays OTHER

Archival tissue will be analyzed using the MammoPrint ® and BluePrint assays

Capecitabine_Non-Luminal A subtypes; Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sonya Reid: lead
• Agendia: collaborator
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (3)

University of Alabama Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Sonya Reid, MD

  Vanderbilt University/Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanderbilt-Ingram Services for Timely Access

CONTACT

800-811-8480; cip@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 23, 2023
• Study Start: September 28, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2037
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (3)