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NCT06439693 · ClinicalTrials.gov registry record · Phase 2
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
A Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT06439693: Recruiting Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by Dana-Farber Cancer Institute.
NCT06439693 is a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 72 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06439693, a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study 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)
Primary Outcome
DFS4 is the probability estimate 4 years based on Kaplan-Meier Method. DFS is defined the time from registration to disease progression (including death from any cause) or resumption of anti-cancer therapy (not including endocrine therapy). Participants that are alive, progression free and off all anti-cancer therapy are censored at the date of their last disease evaluation.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG Nab-Paclitaxel
- DRUG Phesgo
- DRUG T-DM1
Study Locations (1)
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2024-08-08 |
| Est. Completion | 2033-03-30 |
| Phase | Phase 2 |
What NCT06439693 shows while recruiting
NCT06439693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 6 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT06439693 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06439693 about?
NCT06439693 is a clinical study titled "The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer". 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+ Breas...
What is the current status of trial NCT06439693?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2024-08-08. Estimated completion is 2033-03-30.
What conditions does trial NCT06439693 study?
This clinical trial studies the following conditions: Breast Cancer, HER2-positive Breast Cancer, Breast Cancer Female, Stage IV Breast Cancer, Breast Cancer Metastatic.
What interventions are being tested in trial NCT06439693?
The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), Nab-Paclitaxel (DRUG), Phesgo (DRUG), T-DM1 (DRUG).
Who is sponsoring clinical trial NCT06439693?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06439693 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06439693's enrollment target sits among peer trials
72 685th of 1224 higher than 533 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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