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NCT05693766 | RECRUITING | Invasive Mammary Carcinoma

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

Sonya Reid

Information provided by (Responsible Party):

Sonya Reid

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)

Condition or disease

Invasive Mammary Carcinoma

Metastatic Breast Cancer

Intervention/treatment

Capecitabine

Endocrine-therapy

MammoPrint ® and BluePrint assays

Phase

PHASE2

Detailed Description:

Primary Objective: - Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer Secondary Objectives: * Compare the safety and tolerability of capecitabine versus endocrine therapy in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer * Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer Correlatives: * Determine if the tumor mutations detected in cfDNA are early surrogates of response * Determine if the cfDNA results at disease progression show new genomic alterations potentially associated with resistance to therapy

Study Type : INTERVENTIONAL
Estimated Enrollment : 64 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)
Actual Study Start Date : 2023-09-11
Estimated Primary Completion Date : 2027-08-31
Estimated Study Completion Date : 2037-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort

Location Details

NCT05693766

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How to Participate

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Locations

RECRUITING

United States, Tennessee

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37232

RECRUITING

United States, Texas

UT Southwestern Medical Center

Dallas, Texas, United States, 75390