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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

MammaPrint ® and BluePrint assays

Phase

Phase 2

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 (Open Label)
Primary Purpose : Treatment
Official Title : Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)
Actual Study Start Date : September 11, 2023
Estimated Primary Completion Date : August 31, 2027
Estimated Study Completion Date : August 31, 2037
Arm Intervention/treatment

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

Other: Endocrine-therapy

Other: MammoPrint ® and BluePrint assays

Experimental: Capecitabine_Non-Luminal A subtypes

Drug: Capecitabine

Other: MammoPrint ® and BluePrint assays
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

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

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Locations

Recruiting

United States, Tennessee

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37232