RecruitingPhase 2NCT06439693

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

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study


Sponsor

Dana-Farber Cancer Institute

Enrollment

72 participants

Start Date

Aug 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (SAPPHO) tests a sequential treatment strategy aiming to cure de novo (newly diagnosed) HER2-positive metastatic breast cancer. After initial standard treatment, patients who respond well are given additional targeted therapies in sequence with the goal of achieving long-term remission or cure. **You may be eligible if...** - You are 18 or older with a new (de novo) diagnosis of metastatic breast cancer that is HER2-positive (3+ by IHC on both breast and metastatic biopsies) - You have not had prior treatment for metastatic breast cancer (or have just started standard first-line HER2 therapy — trastuzumab/pertuzumab/taxane — within 6 weeks) - Your heart pumping function (LVEF) is 50% or higher - You are in good general health (ECOG performance status 0–1) - You have adequate blood counts and organ function **You may NOT be eligible if...** - Your HER2 status is 1+ or 2+ (only truly HER2-positive 3+ patients qualify) - You have had prior systemic therapy for invasive breast cancer beyond what is specified above - You are under 18 years old - You have active brain metastases causing symptoms - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNab-Paclitaxel

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

DRUGPaclitaxel

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

DRUGDocetaxel

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

DRUGPhesgo

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

DRUGT-DM1

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

DRUGPertuzumab

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

DRUGTrastuzumab Deruxtecan

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

DRUGTrastuzumab Subcutaneous Subcutaneous

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

DRUGTucatinib

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

DRUGTrastuzumab

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


Locations(1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

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NCT06439693


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