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

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

NCT ID: NCT05693766

Condition: Invasive Mammary Carcinoma
Metastatic Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Capecitabine

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Capecitabine
Description: 2000 mg taken by mouth twice daily for 7 days on, 7 days off
Arm group label: Capecitabine_Non-Luminal A subtypes

Intervention type: Other
Intervention name: Endocrine-therapy
Description: Endocrine therapy administered
Arm group label: Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes

Intervention type: Other
Intervention name: MammoPrint ® and BluePrint assays
Description: Archival tissue will be analyzed using the MammoPrint ® and BluePrint assays
Arm group label: Capecitabine_Non-Luminal A subtypes
Arm group label: Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes

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)

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

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Vanderbilt University/Ingram Cancer Center

Address:
City: Nashville
Zip: 37232
Country: United States

Status: Recruiting

Contact:
Last name: Vanderbilt-Ingram Service for Timely Access

Phone: 800-811-8480
Email: cip@vumc.org

Investigator:
Last name: Sonya Reid, MD
Email: Principal Investigator

Facility:
Name: UT Southwestern Medical Center

Address:
City: Dallas
Zip: 75390
Country: United States

Status: Recruiting

Contact:
Last name: Vanderbilt-Ingram Services for Timely Access

Phone: 800-811-8480

Investigator:
Last name: Heather McArthur, MD, PhD
Email: Principal Investigator

Start date: September 11, 2023

Completion date: August 31, 2037

Lead sponsor:
Agency: Sonya Reid
Agency class: Other

Collaborator:
Agency: Agendia
Agency class: Industry

Collaborator:
Agency: Susan G. Komen Breast Cancer Foundation
Agency class: Other

Source: Vanderbilt-Ingram Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05693766