Brief Summary
This is a substudy of the Cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs Molecular Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of combination of tucatinib and trastuzumab in a population of participants with advancedat a late stage, far along tumours harbouring HER2 amplification or mutations.
Intervention/Treatment
- Drug: Trastuzumab.
- Drug: Tucatinib.
Inclusion Criteria
- Adults, aged 18 years and older, with pathologically confirmed advanced and/or metastatic solid cancer of any histologic type or an earlier diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of a poor prognosisto predict how a disease/condition may progress and what the outcome might be cancer.
- Tumours harbouring somatic HER2 amplification (in the absence of a HER2 mutation) or mutations (with or without concomitant amplification).
- At least one measurable site of disease according to RECIST Version 1.1 or by RANO criteria if primary brain tumours.
- Left ventricular ejection fraction >/= 50%.
- Confirmation of molecular eligibility by the molecular tumoura tissue mass that forms from groups of unhealthy cells board.
- ECOG 0 – 2.
- Received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy, if standard therapy exists.
- Clinical or radiological progression on or following last anticancer therapy unless such anticancer therapy stopped due to toxicity / treatment intolerance.
- Adequate organ system function as assessed by the following minimal laboratory requirements (within 7 days prior to first administration of study drug):
- bone marrowsoft, spongy tissue found in bones that makes blood cells function; plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding >/= 100 x 109/L, ANC >/= 1.5 x 109/L, and haemoglobin >/= 9g/dL (5.6mmol/L);
- liver function; ALT/AST < /= 3 x ULN (in the absence of liver metastases, < /= 5 x ULN for patients with liver involvement) and total bilirubin < /= 1.5xULN;
- renal function; serum creatinine < /= 1.5xULN.
- For non central nervous system (CNS) cancers if brain metastases are present, patients must have either:
- untreated brain metastases < /= 2.0 cm in size not needing immediate local therapy (at the discretion of the treating physician and adjudicated by the Principal Investigator).
- previously treated brain metastases not needing immediate local therapy (at the discretion of the treating physician).
- newly diagnosed brain metastases which require treatment with whole brain radiotherapy given >/= 21 days, stereotactic radiosurgery given >/= 7 days or surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence performed >/= 28 days prior to the first dosethe amount of medication taken of treatment.
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- Signed, written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. to participation in the specific treatment substudy.