NCT06439693View on ClinicalTrials.gov

The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

August 8, 2024

Primary Completion Date

March 30, 2030

Study Completion Date

March 30, 2033

Conditions
Breast Cancer FemaleBreast CancerBreast Cancer MetastaticEstrogen Receptor-positive Breast CancerHER2-positive Breast CancerStage IV Breast Cancer
Interventions
DRUG

Nab-Paclitaxel

Anti-microtubule agent, via intravenous (into the vein) infusion per institutional guidelines.

DRUG

Paclitaxel

Anti-microtubule agent, via intravenous infusion per institutional guidelines.

DRUG

Docetaxel

Anti-microtubule agent, via intravenous infusion per institutional guidelines.

DRUG

Phesgo

Pertuzumab plus trastuzumab plus hyaluronidase-zzxf, 10 or 15mL single-dose vial, via subcutaneous (under the skin) injection per protocol.

DRUG

T-DM1

HER2-targeted antibody-drug conjugate, 16 or 100 mg single-use vials, via intravenous infusion per institutional guidelines.

DRUG

Pertuzumab

Recombinant humanized monoclonal antibody, 20mL single-use vial, via intravenous infusion per institutional guidelines.

DRUG

Trastuzumab Deruxtecan

HER2-directed antibody drug conjugate, 100mg vial, via intravenous infusion per institutional guidelines.

DRUG

Trastuzumab Subcutaneous Subcutaneous

Humanized IgG1 kappa monoclonal antibody, 6mL vial, via subcutaneous injection per institutional guidelines.

DRUG

Tucatinib

Tyrosine Kinase HER2 Inhibitor, 50 or 150mg tablet taken orally per institutional guidelines.

DRUG

Trastuzumab

Humanized IgG1 kappa monoclonal antibody, 150 mg single-dose vial, via intravenous infusion per institutional guidelines.

Trial Locations (1)

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

All Listed Sponsors
collaborator

Translational Breast Cancer Research Consortium

OTHER

collaborator

Johns Hopkins University

OTHER

lead

Dana-Farber Cancer Institute

OTHER