SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Kathy Miller
Study ID
NCT05846789
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SOC Chemotherapy — DRUG
    SOC Chemotherapy will be given AUC 6 IV q3 weeks for a maximum of 9 infusions.
  • Tocilizumab — DRUG
    Tocilizimab 8 mg/ actual body weight in kg IV q4 weeks

Study Details

This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab in in Black and non-Black patients with metastatic triple negative or ER low breast cancer.

Key Dates

Start date
Jul 2, 2024
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Black Monotherapy
  • Experimental: Black Combination treatment
  • Active Comparator: Non-Black Monotherapy
  • Experimental: Non-Black Combination treatment

Primary Outcome Measure

Overall response rate [ Time Frame: through study completion (i.e. up to 2 years) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Carlos Aguilera, BA
[email protected]
404-778-1868
Shipra Gandhi, MD (PRINCIPAL_INVESTIGATOR)
IU Health Joe and Shelly Schwarz Cancer CenterCarmelIndiana46032
Xin Bryan, RN
[email protected]
317-274-5495
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Xin Bryan, RN
[email protected]
317-274-5495
Kathy Miller, MD (PRINCIPAL_INVESTIGATOR)
Sidney and Lois Eskenazi HospitalIndianapolisIndiana46202
Xin Bryan, RN
[email protected]
317-274-5495
Roswell Park Comprehensive Cancer CenterBuffaloNew York14203
Lindsay Moshides, MS
[email protected]
716-854-1300
Sheheryar Kabraji, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27708
Samantha Womack, BA
[email protected]
919-660-1278
Alexandra Thomas, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Emory University· Atlanta, GAIU Health Joe and Shelly Schwarz Cancer Center· Carmel, INIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INSidney and Lois Eskenazi Hospital· Indianapolis, INRoswell Park Comprehensive Cancer Center· Buffalo, NYDuke University· Durham, NC

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