Gene-Guided chemo trial aims to improve survival in tough breast cancer
NCT ID NCT05693766
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether using gene tests (MammoPrint and BluePrint) to guide treatment can help people with a certain type of advanced breast cancer (HR+, HER2-negative) live longer. 64 participants will receive either chemotherapy (capecitabine) or hormone therapy based on their gene signature. The study focuses on a diverse group to make findings more widely applicable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Capecitabine (chemotherapy) and endocrine therapy
- What this could lead to
- If successful, this could show that using gene tests to pick treatments improves survival for people with a hard-to-treat type of breast cancer.
- What could go wrong
- This is a small, early-phase trial (64 people) with no control group, so results may not apply broadly. Chemotherapy has side effects like fatigue and nausea.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Aug 2037
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UT Southwestern Medical Center
RECRUITINGDallas, Texas, 75390, United States
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University of Alabama Birmingham
RECRUITINGBirmingham, Alabama, 35249, United States
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Vanderbilt University/Ingram Cancer Center
RECRUITINGNashville, Tennessee, 37232, United States
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Other studies related to the condition(s) this trial covers.
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- Can a Two-Drug combo outsmart resistant breast and ovarian cancers?
- Can a platform trial match the right drug combo to each tumor?
- Could a walking routine delay resistance to breast cancer therapy?