Actively Recruiting
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
Led by Dana-Farber Cancer Institute · Updated on 2025-06-26
72
Participants Needed
1
Research Sites
450 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
T
Translational Breast Cancer Research Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically or cytologically confirmed unresectable locally advanced or metastatic invasive breast carcinoma with stage IV at diagnosis and imaging evidence of metastasis.
- Diagnosis of HER2-positive invasive breast carcinoma with 3+ immunohistochemistry on breast and metastatic biopsies as defined by ASCO/CAP guidelines.
- No prior systemic therapy for invasive breast cancer except first-line trastuzumab, pertuzumab, taxane within 6 weeks.
- Age 18 years or older.
- ECOG performance status 0 or 1.
- Left ventricular ejection fraction of 50% or higher within 12 weeks before treatment.
- Adequate organ and marrow function within 28 days prior to registration, including specific blood count and liver function levels.
- Participants with HIV infection meeting specified immune and treatment criteria.
- Participants with active or chronic Hepatitis B or C meeting liver function criteria and treatment guidelines.
- Participants with brain metastases must have undergone or completed definitive local therapy and be clinically stable.
- Prior or concurrent malignancies with no interference with safety or efficacy assessment are allowed.
- Women of childbearing potential and men must agree to use adequate contraception before and during the study and for 7 months after treatment.
- Women of childbearing potential must have a negative pregnancy test within 14 days before registration.
- Ability and willingness to provide informed consent and comply with study procedures.
You will not qualify if you...
- Prior history of invasive breast carcinoma.
- Treatment with other investigational agents for this condition.
- Major surgery or significant traumatic injury within 28 days before study entry or planned during the study.
- Extracranial palliative radiotherapy within 7 days before enrollment.
- Allergic reactions to similar compounds as study drugs.
- History of myocardial infarction within 6 months or symptomatic congestive heart failure (NYHA Class II to IV).
- Untreated brain lesions unless approved by the Sponsor Investigator.
- Use of systemic corticosteroids for brain metastases symptoms exceeding 2 mg dexamethasone daily.
- Known or concurrent leptomeningeal disease or poorly controlled seizures.
- History of symptomatic or treatment-requiring arrhythmias or uncontrolled atrial fibrillation.
- History or current interstitial lung disease or pneumonitis requiring steroids or suspected but unexcluded at screening.
- Other lung diseases such as recent pulmonary emboli, severe asthma, COPD, restrictive lung disease, pleural effusion, or autoimmune disorders with pulmonary involvement.
- Prior pneumonectomy.
- Active or uncontrolled serious infections.
- Inability to swallow pills or gastrointestinal disease affecting oral medication absorption.
- Ongoing grade 2 or higher diarrhea.
- Use of medications that inhibit or induce CYP2C8 or CYP3A4 enzymes.
- Pregnant or breastfeeding women.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
N
Nancy Lin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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