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A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

Status
Closed
Cancer Type
Breast Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04539938
Protocol IDs
SGNTUC-025 (primary)
NCI-2020-08177
Study Sponsor
Seagen Inc.

Summary

This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan
(T-DXd). It will also look at what side effects happen when these drugs are given together. A
side effect is anything a drug does besides treating cancer.

Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to
other parts of the body (metastatic) or cannot be removed completely with surgery
(unresectable). All participants will get both tucatinib and T-DXd.

Eligibility

  1. Have confirmed HER2+ breast cancer, as defined by the current American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines, previously determined at a Clinical Laboratory Improvements Amendments (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory.
  2. History of prior treatment with a taxane and trastuzumab in the LA/M setting OR progressed within 6 months after neoadjuvant or adjuvant treatment, including a taxane and trastuzumab.
  3. Have progression of unresectable LA/M breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy
  4. Have measurable disease assessable by RECIST v1.1
  5. Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
  6. Have a life expectancy of at least 6 months, in the opinion of the investigator
  7. CNS Inclusion - Based on medical history and screening contrast brain magnetic resonance imaging (MRI), participants with a history of brain metastases must have one of the following:
  8. Untreated brain metastases not needing immediate local therapy. For participants with untreated central nervous system (CNS) lesions >2.0 cm on screening contrast brain MRI, discussion with and approval from the medical monitor is required prior to enrollment
  9. Previously treated brain metastases
  10. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator
  11. Participants treated with CNS local therapy for newly identified or previously treated progressing lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if all of the following criteria are met:
  12. Time since whole brain radiation therapy (WBRT) is =14 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is =7 days prior to first dose of study treatment, or time since surgical resection is =28 days
  13. Other sites of measurable disease by RECIST v1.1 are present
  14. Relevant records of any CNS treatment must be available
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.