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OncoMatch/Clinical Trials/NCT06833502

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

Is NCT06833502 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for breast cancer.

Phase 2RecruitingH. Lee Moffitt Cancer Center and Research InstituteNCT06833502Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 expression ≥ 10% (≥ 10%)

HR+ will be defined as ER and/or PR ≥ 10%

Required: PR (PGR) expression ≥ 10% (≥ 10%)

HR+ will be defined as ER and/or PR ≥ 10%

Required: HER2 (ERBB2) overexpression

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.

Required: ESR1 expression <10% (<10%)

Triple negative will be classified as ER and PR <10% and HER2-.

Required: PR (PGR) expression <10% (<10%)

Triple negative will be classified as ER and PR <10% and HER2-.

Required: HER2 (ERBB2) wild-type

Triple negative will be classified as ER and PR <10% and HER2-.

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: anthracycline — neoadjuvant

Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen.

Must have received: taxane — neoadjuvant

Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen.

Must have received: HER2-targeted therapy — neoadjuvant

To include HER2 directed therapy for HER2+ patients.

Lab requirements

Kidney function

chronic kidney disease stage iv or v or end stage renal disease (crcl <30 ml/min) [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Moffitt Cancer Center · Tampa, Florida

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