Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer
Recruiting
Phase 2
Interventional Study
Breast Cancer
Node-positive Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Screening
- Participants needed
- 120 (estimated)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Other
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About This Trial
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, abd…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status.
* HR+ will be defined as ER and/or PR ≥ 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines27. …
Contacts