Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-04 @ 11:44 PM
Study NCT ID:
NCT06439693
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2024-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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)
Detailed Description:
This is an open-label phase II single-arm study to test the efficacy of a regimen of human epidermal growth factor receptor 2 (HER2)-targeted study drugs in participants with HER2-Positive metastatic Breast Cancer (HER2+ MBC).
The U.S. Food and Drug Administration (FDA) has approved all the study drugs as a treatment option for metastatic, HER2+ breast cancer. In this study, investigators are planning to give a series of treatments in a row without waiting for disease worsening and then stopping HER2 treatment.
The research study procedures include screening for eligibility, study treatment visits, blood tests, tumor biopsies, questionnaires, Computed Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, echocardiograms, and electrocardiograms.
Participation in this research study is expected to last about 93 weeks (12 weeks for Part A, 18 weeks for Part B, 12 weeks for Part C, and 51 weeks for Part D) for study treatment and approximately three months to ten years for follow up.
It is expected that about 72 people will take part in this research study.
Seagen Inc. is supporting this study by providing the study drug, tucatinib, and funding.
The U.S. Food and Drug Administration (FDA) has approved all the study drugs as a treatment option for metastatic, HER2+ breast cancer. In this study, investigators are planning to give a series of treatments in a row without waiting for disease worsening and then stopping HER2 treatment.
The research study procedures include screening for eligibility, study treatment visits, blood tests, tumor biopsies, questionnaires, Computed Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, echocardiograms, and electrocardiograms.
Participation in this research study is expected to last about 93 weeks (12 weeks for Part A, 18 weeks for Part B, 12 weeks for Part C, and 51 weeks for Part D) for study treatment and approximately three months to ten years for follow up.
It is expected that about 72 people will take part in this research study.
Seagen Inc. is supporting this study by providing the study drug, tucatinib, and funding.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TBCRC065 | OTHER | TBCRC | View |