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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Carlo
Palmieri
+44 (0)151 7949813
C.Palmieri@liverpool.ac.uk
Dr
Liverpool
Clinical Trials Centre
None provided
3-pillars@liverpool.ac.uk
Prof
Carlo
Palmieri
+44 (0)151 7949813
C.Palmieri@liverpool.ac.uk
ER-positive, PgR-positive and HER2-positive early breast cancer
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
This is a study where patients with early breast cancer will be given a combination of medications before they have their operation to remove the breast cancer. We want to look at whether this combination of drugs may be successful as a treatment for early breast cancer. We will be looking at post-menopausal women with early breast cancer that is ER-positive, PgR-positive and HER2-positive, and who are eligible for surgery. Breast cancer that has a significant number of receptors for either oestrogen (ER+) or progesterone (PgR+) is considered hormone-receptor positive and can be treated with either hormone therapy alone or chemotherapy followed by hormone therapy. ER+ breast cancers are routinely treated with hormone therapy that blocks the oestrogen receptor, this type of therapy is more effective when combined with another drug which blocks a molecule called CDK4/6. About 15% of all breast tumours have higher levels of a protein known as HER2, called HER2-positive (HER2+) breast cancers. These cancers tend to grow and spread faster than breast cancers that are HER2-negative, but are much more likely to respond to routine treatment with drugs that target the HER2 protein. 50% of HER2+ breast cancers are also ER+. Research has shown that the combination of HER2 therapy with hormone therapy is more active than hormone therapy alone.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Any patient meeting any of the criteria listed below will be excluded from study participation: 1. Inflammatory or inoperable breast cancer 2. Evidence of bilateral invasive breast cancer 3. Clinically or radiological evidence of metastatic disease (staging to be done in accordance with local guideline) 4. Concomitant use (defined as use within 12 weeks prior to entry) of Hormone Replacement Therapy (HRT) or any other oestrogen-containing medication or supplementation 5. Any prior treatment with any CDK 4/6 inhibitor 6. Use of a strong CYP3A4 or CYP2C8 inhibitor, or food or drugs that are known CYP3A4 inhibitors, within 2 weeks of starting study treatment and during study (See Appendix 3) 7. Use of a strong CYP3A4 or CYP2C8 inducer, or drugs known to be CYP3A4 inducers, within 5 days of starting study treatment and during study (See Appendix 2 and Appendix 3) 8. No plan to commence treatment with CYP3A substrates within 2 weeks of starting study treatment and during study (See Appendix 1) 9. Any prior treatment with HER2-directed therapy 10. Previous investigational medicinal products for any condition within 4 weeks of registration date 11. Any prior history of invasive malignancy within 5 years of starting treatment where there is a medium or high risk of reoccurrence (other than treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ or cancers treated with surgery alone). 12. QTc >480 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP) 13. Significant cardiovascular disease including but not limited to: 13.1. History of documented congestive cardiac failure 13.2. Angina pectoris requiring anti-anginal medication 13.3. Evidence of transmural infarction on ECG 13.4. Poorly controlled hypertension or uncontrolled asymptomatic hypertension as determined by the investigator 13.5. Clinically significant valvular heart disease 13.6. Ventricular significant arrhythmia requiring therapy 13.7. High-risk uncontrolled arrhythmias or sudden cardiac arrest 14. Has significant gastro-intestinal disease including but not limited to active inflammatory bowel disease, chronic diarrhoea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection which would preclude the adequate oral absorption of medications.15. Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging (e.g., hypocalcaemia, hypokalaemia, hypomagnesemia) 16. Evidence of bleeding diathesis 17. Active bacterial infection (as defined by the use of oral or IV antibiotics at the time of study registration or systemic fungal infection 18. Known human immunodeficiency virus (HIV) positivity (screening HIV is not required for study enrolment) 19. Known active or inactive hepatitis carrier, for example, hepatitis B surface antigen (HBsAg) positive (screening hepatitis B or C is not required for study enrolment) 20. Recent vaccination with a live virus defined as within 28 days of study registration 21. Known hypersensitivity to letrozole, palbociclib, trastuzumab or tucatinib, or to any of the excipients.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Carlo
Palmieri
+44 (0)151 7949813
C.Palmieri@liverpool.ac.uk
Prof
Carlo
Palmieri
+44 (0)151 7949813
C.Palmieri@liverpool.ac.uk
Dr
Liverpool
Clinical Trials Centre
None provided
3-pillars@liverpool.ac.uk
The study is sponsored by University of Liverpool and funded by Seagen.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 58079
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
