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

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)

Conditions

• Breast Cancer Female
• Breast Cancer
• Breast Cancer Metastatic
• Estrogen Receptor-positive Breast Cancer
• HER2-positive Breast Cancer
• Stage 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.

Sponsors & Collaborators

• Translational Breast Cancer Research Consortium

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Dana-Farber Cancer Institute

  lead OTHER

Principal Investigators

• Nancy Lin, MD · Dana-Farber Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-08

Primary Completion

2030-03-30

Completion

2033-03-30

FDA Drug

Yes

Countries

• United States

Study Locations