Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer

Sponsor
UNICANCER
Study ID
NCT07151586
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • HER 2 Low-expressing Breast Cancer
  • Neoplasm Metastasis
  • Triple Negative Breast Neoplasms

Eligibility Criteria

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

Interventions

  • Sacituzumab Govitecan / Trastuzumab Deruxtecan — DRUG
    Sacituzumab govitecan is administered intravenously at a dose of 10 mg/kg on Day 1 and Day 8 of each 3-week cycle. In this study, patients receive two cycles of sacituzumab govitecan followed by two cycles of trastuzumab deruxtecan, alternating throughout the study. Trastuzumab deruxtecan is administered intravenously at a dose of 5.4 mg/kg on Day 1 of each 3-week cycle. In this study, patients receive two cycles of trastuzumab deruxtecan followed by two cycles of sacituzumab govitecan, alternating throughout the study. Both Treatment are continued until disease progression as defined by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or the end of the study.

Study Details

This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or metastatic triple-negative breast cancer. The goal is to answer the question: Does alternating sacituzumab goveitecan (SG) and trastuzumab deruxtecan (T-DXd) improve survival in patients with HER2-low metastatic triple-negative breast cancer compared to continuing treatment with SG alone?

Key Dates

Start date
Oct 31, 2025
Status verified
Aug 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab-Govitecan and Trastuzumab-deruxtecan in alternating shema
    Patients will receive either SG and T-DXd in an upfront alternating schema: two cycles of SG, followed by two cycles of T-DXd, then two cycles of SG, and so on, until RECIST 1.1-defined disease progression, unless there is unacceptable toxicity, withdrawal of consent or end of study.
  • Active Comparator: Sacituzumab-Govitecan alone
    Patient will receive Sacituzumab-Govitecan 1(monotherapy) until RECIST 1.1-defined disease progression, unless there is unacceptable toxicity, withdrawal of consent or end of study

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From randomization to death from any cause, up to 4 years. ]

Central Contacts

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