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

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Enrolling; Phase 2

Conditions: Node-positive Breast Cancer; Breast Cancer

Treatments: Other: CT Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT06833502

MCC-23433

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. Triple negative will be classified as ER and PR <10% and HER2-.
• Node positive HER2+ and triple negative breast cancer (ypN+) following receipt of neoadjuvant chemotherapy. HR+/HER2- patients should have ypN2 or ypN3 disease following receipt of neoadjuvant chemotherapy and surgery.
• Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen. To include HER2 directed therapy for HER2+ patients.
• Age ≥ 18.
• Life expectancy ≥ 6 months.
• Eastern Cooperative Oncology Group performance status 0 to 2.
• Patients must be able to understand and the willingness to sign an informed consent for study procedures.
• Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion criteria

• Prior diagnosis of systemic metastases.
• Patients with prior history of non-breast cancer malignancies should have NED ≥ 2 years excluding adequately treated non-melanoma skin cancer, in situ cancer of the cervix or bladder.
• Contraindication towards CT IV contrast.
• Chronic kidney disease stage IV or V or end stage renal disease (CrCl <30 ml/min).

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Triple negative

Other group

Description:

Participants diagnosed with triple negative breast cancer.

Treatment:

Other: CT Scan

HER2+

Other group

Description:

Participants diagnosed with HER2+ breast cancer.

Treatment:

Other: CT Scan

Hormone receptor (HR)+

Other group

Description:

Participants diagnosed with hormone receptor (HR)+ breast cancer.

Treatment:

Other: CT Scan