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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06439693
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nab-Paclitaxel — DRUG
    Anti-microtubule agent, via intravenous (into the vein) infusion per institutional guidelines.
  • Paclitaxel — DRUG
    Anti-microtubule agent, via intravenous infusion per institutional guidelines.
  • Docetaxel — DRUG
    Anti-microtubule agent, via intravenous infusion per institutional guidelines.
  • Phesgo — DRUG
    Pertuzumab plus trastuzumab plus hyaluronidase-zzxf, 10 or 15mL single-dose vial, via subcutaneous (under the skin) injection per protocol.
  • T-DM1 — DRUG
    HER2-targeted antibody-drug conjugate, 16 or 100 mg single-use vials, via intravenous infusion per institutional guidelines.
  • Pertuzumab — DRUG
    Recombinant humanized monoclonal antibody, 20mL single-use vial, via intravenous infusion per institutional guidelines.
  • Trastuzumab Deruxtecan — DRUG
    HER2-directed antibody drug conjugate, 100mg vial, via intravenous infusion per institutional guidelines.
  • Trastuzumab Subcutaneous Subcutaneous — DRUG
    Humanized IgG1 kappa monoclonal antibody, 6mL vial, via subcutaneous injection per institutional guidelines.
  • Tucatinib — DRUG
    Tyrosine Kinase HER2 Inhibitor, 50 or 150mg tablet taken orally per institutional guidelines.
  • Trastuzumab — DRUG
    Humanized IgG1 kappa monoclonal antibody, 150 mg single-dose vial, via intravenous infusion per institutional guidelines.

Study Details

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)

Key Dates

Start date
Aug 8, 2024
Status verified
Jun 2025
Primary completion
Mar 30, 2030
Completion
Mar 30, 2033

Study Design

Enrollment
72 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HER2+ Breast Cancer
    Participants will complete: * Screening visit with tumor biopsy and imaging. * Imaging on Day I of cycles for Parts A through D. * Part A: * Day 1 of 21 day cycle: Predetermined dose of Trastuzumab (or biosimilar) 1X daily * Day 1 of 21 day cycle: Predetermined dose of Pertuzumab 1X daily * Predetermined dose of Taxane (Paclitaxel, Docetaxel, or Nab-Paclitaxel) * Part B: --Day 1 of 21 day cycle: Predetermined dose of trastuzumab deruxtecan 1X daily * Part C: * Day 1 of 21 day cycle: Predetermined dose of T-DM1 1X daily * Days 1 through 21 of 21 day cycle: Predetermined dose of Tucatinib 2X daily * Part D: * Imaging every 9 weeks * Days 1 through 21 of 21 day cycle: Predetermined dose of Tucatinib 2X daily * Day 1 of 21 day cycle: Predetermined dose of Trastuzumab (biosimilar or SC) 1X daily * Day 1 of 21 day cycle: Predetermined dose of Pertuzumab (or PHESGO) 1X daily * Follow Up: visits every 12 weeks with imaging every 9 weeks.

Primary Outcome Measure

Disease Free Survival at 4 Years (DFS4) [ Time Frame: Up to 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Nancy Lin, MD
[email protected]
617-632-2335
Nancy Lin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dana-Farber Cancer Institute· Boston, MA

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