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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06439693 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy, investigational agent disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression (IHC 3+ on both breast and metastatic biopsies, per ASCO/CAP guidelines) is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages