OncoMatch/Clinical Trials/NCT06439693
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
Is NCT06439693 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast cancer female.
Treatment: Nab-Paclitaxel · Paclitaxel · Docetaxel · Phesgo · T-DM1 · Pertuzumab · Trastuzumab Deruxtecan · Trastuzumab Subcutaneous Subcutaneous · Tucatinib · Trastuzumab — The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants. The names of the study drugs involved in this study are: * Paclitaxel (a type of anti-microtubule agent) * Docetaxel (a type of anti-microtubule agent) * Nab-Paclitaxel (a type of anti-microtubule agent) * Trastuzumab (a type of IgG1 kappa monoclonal antibody) * Pertuzumab (a type of monoclonal antibody) * Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate) * Tucatinib (Tyrosine Kinase HER2 Inhibitor) * Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ on both breast and metastatic biopsies, per ASCO/CAP guidelines) (IHC 3+)
Diagnosis of HER2-positive invasive breast carcinoma and 3+ by immunohistochemistry on both breast and metastatic biopsies, as defined by the current American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: HER2-targeted therapy (trastuzumab, pertuzumab, taxane) — first-line for metastatic disease
No prior systemic therapy for invasive breast cancer, aside from first-line trastuzumab/pertuzumab/taxane (THP) within 6 weeks from treatment start
Cannot have received: systemic therapy
Exception: first-line trastuzumab/pertuzumab/taxane (THP) within 6 weeks from treatment start
No prior systemic therapy for invasive breast cancer, aside from first-line trastuzumab/pertuzumab/taxane (THP) within 6 weeks from treatment start
Cannot have received: investigational agent
Treatment with any other investigational agents for this condition
Lab requirements
Blood counts
Hgb ≥9.0 g/dL; Absolute Neutrophil Count ≥ 1,000 /mm3; Platelets ≥100,000/mm3
Kidney function
Serum creatinine ≤ 1.5 x ULN (institutional) OR calculated GFR ≥60mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN (institutional) or direct bilirubin within normal limits in patients with a history of Gilbert's syndrome. AST and ALT ≤ 2.5 x ULN (institutional) or ≤ 5 x ULN for participants with documented liver metastases
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50%, as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
Participants must meet the following organ and marrow function as defined below within 28 days prior to registration: Hgb ≥9.0 g/dL; Absolute Neutrophil Count ≥ 1,000 /mm3; Platelets ≥100,000/mm3; Total bilirubin ≤ 1.5 x ULN (institutional) or direct bilirubin within normal limits in patients with a history of Gilbert's syndrome. AST and ALT ≤ 2.5 x ULN (institutional) or ≤ 5 x ULN for participants with documented liver metastases; Serum creatinine ≤ 1.5 x ULN (institutional) OR calculated GFR ≥60mL/min; Left ventricular ejection fraction (LVEF) ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana-Farber Cancer Institute · Boston, Massachusetts
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