OncoMatch/Clinical Trials/NCT06172127
PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer
Is NCT06172127 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trastuzumab deruxtecan and Phesgo 1,200 MG / 600 MG / 30,000 UNT Per 15 ML for her2-positive breast cancer.
Treatment: Trastuzumab deruxtecan · Phesgo 1,200 MG / 600 MG / 30,000 UNT Per 15 ML · Phesgo 600 MG / 600 MG / 20,000 UNT in 10 mL — DEMETHER is a phase II trial exploring the maintenance of trastuzumab and pertuzumab fixed dose combination (FDC) for subcutaneous administration (SC, PHESGO) following trastuzumab deruxtecan (T-DXd) as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer (MBC) patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
Evidence of HER2-overexpressing tumor status confirmed by any MEDSIR's designated central lab or patient has a pathology report confirming HER2-overexpression by local testing
Required: ESR1 expression
Must have known estrogen receptor (ER) ... status locally determined prior to study entry.
Required: PR (PGR) expression
Must have known ... progesterone receptor (PgR) status locally determined prior to study entry.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: adjuvant or neoadjuvant chemotherapy allowed if DFI ≥ 12 months
No prior chemotherapy ... for advanced disease (one prior line of endocrine therapy is allowed for MBC). May have received adjuvant or neoadjuvant chemotherapy ... with a disease-free interval (DFI) from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of at least 12 months.
Cannot have received: HER2-targeted therapy
Exception: adjuvant or neoadjuvant HER2-targeted therapy allowed if DFI ≥ 12 months
No prior ... HER2-targeted therapy for advanced disease ... May have received adjuvant or neoadjuvant ... HER2-targeted therapy ... with a disease-free interval (DFI) from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of at least 12 months.
Cannot have received: HER2-targeted therapy (trastuzumab deruxtecan)
Has previously been treated with T-DXd in the adjuvant or neoadjuvant setting.
Lab requirements
Blood counts
WBC > 3.0 x 10^9/L, ANC ≥ 1.5 x 10^9/L, platelet count ≥ 100.0 x 10^9/L, hemoglobin (Hb) ≥ 9.0 g/dL
Kidney function
Creatinine clearance ≥ 50 mL/min as determined by Cockcroft Gault (using actual body weight)
Liver function
Serum albumin ≥ 2.5 g/dL; total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN in patients with Gilbert's disease); ALP ≤ 2.5 x ULN (≤ 5 × ULN in patients with liver and/or bone metastases); AST and ALT ≤ 1.5 x ULN (≤ 3 x ULN in patients with liver metastases)
Cardiac function
LVEF ≥ 55% by MUGA or ECHO; no unstable angina, MI, or symptomatic CHF (NYHA II-IV) within 6 months; no poorly controlled hypertension (SBP ≥ 180 mmHg or DBP ≥ 100 mmHg); no symptomatic pericarditis; no significant arrhythmias; QTcF ≤ 470 ms (females) or ≤ 450 ms (males); no history of QT prolongation requiring discontinuation of medication; no congenital long QT syndrome or family history of long QT syndrome or unexplained sudden death under 40 years in first-degree relatives.
Adequate hematologic and organ function, defined by the following: ... Hematological ... Hepatic ... Renal ... Coagulation ... Cardiac exclusion criteria detailed in exclusion 9.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Northwell Health · New York, New York
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