An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
Trial Status: closed to accrual
This trial studies how well tucatinib works for solid tumors that make either more HER2
or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in
this trial have either spread to other parts of the body (metastatic) or cannot be
removed completely with surgery (unresectable).
All participants will get both tucatinib and trastuzumab. People with hormone-receptor
positive breast cancer will also get a drug called fulvestrant.
The trial will also look at what side effects happen. A side effect is anything a drug
does besides treating cancer.
Inclusion Criteria
Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic solid tumor, including primary brain tumors
Participants with non-squamous NSCLC must have progressed during or after standard treatment or for which no standard treatment is available
Participants with other disease types must have progressed during or after ≥1 prior line of systemic therapy for locally-advanced unresectable or metastatic disease
Disease progression during or after, or intolerance of, the most recent line of systemic therapy
Disease demonstrating HER2 alterations (overexpression/amplification or HER2 activating mutations), as determined by local or central testing processed in a Clinical Laboratory Improvement Amendments (CLIA)- or International Organization for Standardization (ISO) accredited laboratory, according to one of the following:
HER2 overexpression/amplification from fresh or archival tumor tissue or blood
Known activating HER2 mutations detected in fresh or archival tumor tissue or blood
Have measurable disease per RECIST v1.1 criteria according to investigator assessment
Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
Participants with breast cancer, gastric or gastroesophageal junction adenocarcinoma, or CRC whose disease shows HER2 amplification/overexpression.
Previous treatment with HER2-directed therapy; participants with uterine serous carcinoma or HER2-mutated gastric or gastroesophageal junction adenocarcinoma without HER2-overexpression/amplification may have received prior trastuzumab
Known hypersensitivity to any component of the drug formulation of tucatinib or trastuzumab (drug substance, excipients, murine proteins), or any component of the drug formulation of fulvestrant in participants with HR+ HER2-mutated breast cancer
History of exposure to a 360 mg/m² doxorubicin-equivalent or >720 mg/m^2 epirubicin-equivalent cumulative dose of anthracyclines
Treatment with any systemic anti-cancer therapy, radiation therapy, major surgery, or experimental agent within ≤3 weeks of first dose of study treatment or are currently participating in another interventional clinical trial. There are additional inclusion and exclusion criteria. The study center will determine if
criteria for participation are met.
Additional locations may be listed on ClinicalTrials.gov for NCT04579380.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
There are multiple cohorts in this trial:
- 5 tumor specific cohorts with HER2 overexpression/amplification (cervical cancer,
uterine cancer, biliary tract cancer, urothelial cancer, and non-squamous non-small
cell lung cancer [NSCLC])
- 2 tumor specific cohorts with HER2 mutations (non-squamous NSCLC and breast cancer)
- 2 cohorts which will enroll all other HER2 amplified/overexpressed solid tumor types
(except breast cancer, gastric or gastroesophageal junction adenocarcinoma [GEC],
and colorectal cancer [CRC]) or HER2-mutated solid tumor types.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationSeagen, a wholly owned subsidiary of Pfizer
