Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06833502
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • CT Scan — OTHER
    Participants will undergo a screening CT thorax, abdomen, pelvis at baseline prior to adjuvant radiation therapy and additional screening CT thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.

Study Details

The purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. Participants will be asked to spend about 6 months in this study. Participants will undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.

Key Dates

Start date
Feb 24, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Other: Triple negative
    Participants diagnosed with triple negative breast cancer.
  • Other: HER2+
    Participants diagnosed with HER2+ breast cancer.
  • Other: Hormone receptor (HR)+
    Participants diagnosed with hormone receptor (HR)+ breast cancer.

Primary Outcome Measure

Systemic Metastasis [ Time Frame: Baseline and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Kamran Ahmed, MD (PRINCIPAL_INVESTIGATOR)
Matthew Mills, MD (PRINCIPAL_INVESTIGATOR)
Avan Armaghani, MD (SUB_INVESTIGATOR)
Ricardo Costa, MD (SUB_INVESTIGATOR)
Roberto Diaz, MD, PhD (SUB_INVESTIGATOR)
Loretta Loftus, MD (SUB_INVESTIGATOR)
Tracey O'Connor, MD (SUB_INVESTIGATOR)
Hatem Soliman, MD (SUB_INVESTIGATOR)
Aixa Soyano Muller, MD (SUB_INVESTIGATOR)
Iman Washington, MD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Moffitt Cancer Center· Tampa, FL

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