* Basketstudy of tucatinib&trastuzumab for tumours w/t HER2 alterations
Research type
Research Study
Full title
A Phase 2 Basket Study of Tucatinib in Combination with Trastuzumab in Subjects with Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations
IRAS ID
292412
Contact name
Alicia Okines
Contact email
Sponsor organisation
Seagen Inc.
Eudract number
2020-004873-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 152278
Duration of Study in the UK
4 years, 0 months, 7 days
Research summary
This study will take place at multiple centers and internationally. The study uses an investigational (experimental) combination of anti-cancer drugs in patients with selected solid cancers with HER2 alterations. ‘HER2 alterations’ means that the patients’ cancer may grow more quickly or spread faster or may affect their response to standard treatments. The cancer in this study has spread to other parts of their body or cannot be removed by surgery.
The experimental drug is called tucatinib. It is approved in some countries (including USA, Singapore, Australia, Canada and Switzerland) for adults with HER2-positive breast cancer that is advanced or has spread through the body and cannot be removed with surgery. Tucatinib is currently only approved for use with two other anti-cancer drugs, trastuzumab and capecitabine. The brand name for tucatinib is TUKYSA™. It has not been approved for treatment of other cancers.
This study also uses another drug called trastuzumab. Trastuzumab (also known as Herceptin) has been approved to treat HER2 positive breast cancer and stomach cancer. Patients with hormone-receptor positive HER2-mutant breast cancer will receive tucatinib, trastuzumab, and another drug called fulvestrant in the study. Fulvestrant (also known as Faslodex) has been approved to treat certain types of breast cancer.
This study is being done to find out if Tucatinib works for cancers with HER2 alterations. This study also wants to find out what side effects are in different types of cancer. Learning about the side effects of tucatinib and how well it works will help understand if tucatinib is better or worse than other treatments for cancers with HER2 alterations.
Patients who give their consent and are eligible for the study will enter separate cohorts based on their cancer histology and HER2 alteration status. Approximately 162 to 270 subjects may be enrolled into the study.
Each treatment cycle lasts 21 days. Patients will swallow tucatinib tablets two times per day. Patients will also receive intravenous trastuzumab on the first day of each cycle. If the patient has hormone receptor positive breast cancer, the patient will also receive 2 intramuscular fulvestrant injections every 4 weeks, with an extra dose 2 weeks after the first dose.
While on study treatment, patients will be assessed for progression every 6 weeks for the first 6 months, and every 12 weeks thereafter. Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. After completion of study treatment and after occurrence of disease progression, patients will continue to be followed for survival until study closure, death or withdrawal of consent.
The study will be closed approximately 3 years after the last patient has entered the study or when no patients remain in long-term follow-up, whichever occurs first.REC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0194
Date of REC Opinion
1 Apr 2021
REC opinion
Further Information Favourable Opinion