Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
The SAPPHO Study A Single-Arm Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2 Metastatic Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 US 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 US 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TBCRC065 | OTHER | TBCRC | None |