Clinical Trials Logo

Clinical Trial Summary

This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care. SECONDARY OBJECTIVES: I. To compare cumulative direct healthcare costs through 48 weeks among patients monitored with STMDDM versus those monitored with usual care in this patient population. II. To assess whether the patient-reported outcomes (PROs) of anxiety and quality of life (QOL) are different among patients who are monitored with STMDDM compared with patients who are monitored with usual care in this patient population. TERTIARY OBJECTIVES: I. To assess modality and frequency of disease monitoring testing in the usual care cohort. II. To assess the association of PROs and patient preferences for disease monitoring testing. III. To evaluate predictors of physician preferences for disease monitoring testing. OUTLINE: Patients are randomized into 1 of 2 arms. ARM I: Patients undergo imaging studies at a minimum frequency of every 12 weeks and continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression. ARM II: Patients undergo disease specific serum tumor marker (STM) evaluation every 4-8 weeks. Patients with elevated STM, undergo imaging evaluation. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03723928
Study type Interventional
Source SWOG Cancer Research Network
Contact
Status Recruiting
Phase N/A
Start date September 17, 2018
Completion date December 1, 2036

See also
  Status Clinical Trial Phase
Suspended NCT05673200 - Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer Phase 1
Active, not recruiting NCT03218826 - PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Recruiting NCT04521764 - A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer Phase 1
Suspended NCT03737695 - Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast Cancer
Active, not recruiting NCT04316117 - Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study Phase 2
Not yet recruiting NCT04529044 - 177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer Phase 2
Recruiting NCT04862585 - Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel Phase 2/Phase 3
Completed NCT00338728 - Letrozole and Imatinib Mesylate in Treating Postmenopausal Participants With Estrogen or Progesterone Positive Metastatic Breast Cancer Phase 2
Withdrawn NCT05967286 - Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial Phase 2
Recruiting NCT04673448 - Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Active, not recruiting NCT05081492 - CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer Phase 1
Recruiting NCT05318469 - Ivermectin and Balstilimab for the Treatment of Metastatic Triple Negative Breast Cancer Phase 1/Phase 2
Not yet recruiting NCT05539365 - Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer Phase 2
Terminated NCT05198843 - Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body Phase 1/Phase 2
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Recruiting NCT05751668 - Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel (Phase II) Phase 2
Suspended NCT04906369 - Optimizing Treatment of Stage IV Breast Cancer Through Real-Time Disease Monitoring
Completed NCT03291938 - IACS-010759 in Advanced Cancers Phase 1
Recruiting NCT04314401 - National Cancer Institute "Cancer Moonshot Biobank"
Withdrawn NCT04351230 - T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer Phase 2