Trials / Recruiting
RecruitingNCT06439693
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- Sponsor
- Dana-Farber Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
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.
Conditions
- Breast Cancer Female
- Breast Cancer
- Breast Cancer Metastatic
- Estrogen Receptor-positive Breast Cancer
- HER2-positive Breast Cancer
- Stage IV Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-08-08
- Primary completion
- 2030-03-30
- Completion
- 2033-03-30
- First posted
- 2024-06-03
- Last updated
- 2025-06-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06439693. Inclusion in this directory is not an endorsement.