Recruiting
Phase 2

Gene Signatures

Sponsor:

Sonya Reid

Code:

NCT05693766

Conditions

Invasive Mammary Carcinoma

Metastatic Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Capecitabine

Endocrine-therapy

MammoPrint ® and BluePrint assays

Study Details

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

Study ID

NCT05693766

Start date

Sep 28, 2023

Status verified date

Jan, 2026

Completion date

Aug 31, 2037

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 Criteria:

  • 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.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Physician's Choice of Endocrine-based Therapy Non-Luminal A subtypes

experimental: Capecitabine Non-Luminal A subtypes

Interventions

Capecitabine

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

Endocrine-therapy

Endocrine therapy administered

MammoPrint ® and BluePrint assays

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

Primary outcome measure

  • Progression free survival [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Vanderbilt-Ingram Services for Timely Access

800-811-8480cip@vumc.org

Locations

University of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35249

Principal Investigator:

Nusrat Jahan

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Vanderbilt-Ingram Service for Timely Access

800-811-8480cip@vumc.org

Principal Investigator:

Sonya Reid, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Vanderbilt-Ingram Services for Timely Access

800-811-8480

Principal Investigator:

Heather McArthur, MD, PhD

More Information

Sponsor

Sonya Reid

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sonya Reid on 2026-01-20.