Ask to take part

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.

Contact Information:

Ms Katie Goddard


Study Location:

Skip to Main Content

Keep up to date

Sign up for news and information about taking part and shaping research.

English | Cymraeg
Be Part of Research - Trial Details - Evaluating the biological and clinical effects of the combination of palbociclib with letrozole as neoadjuvant therapy in post-menopausal women with primary breast cancer

Evaluating the biological and clinical effects of the combination of palbociclib with letrozole as neoadjuvant therapy in post-menopausal women with primary breast cancer

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Post-menopausal patients with ER+ and HER2- primary 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.


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:

23 Feb 2015 08 Mar 2018

Publications

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30523750 results (added 26/02/2019)

Interventional

Intervention Type : Drug
Intervention Description : 1. Palbociclib is an unlicensed drug that is a 125-mg capsule that should be administered orally. The treatment schedule is 3 weeks on, 1 week off.2. Letrozole is a 2.5-mg tablet that will be administered orally on a daily basis. Both drugs will be taken for up to 14 weeks, depending on treatment arm. Patients will be followed up for 1 year after date of randomisation.




You can take part if:



You may not be able to take part if:


1. Premenopausal or perimenopausal women2. Inflammatory/inoperable breast cancer3. HER2 positive 4. Concurrent use (defined as use within 4 weeks prior to baseline tissue sample being taken) of HRT or any other oestrogen-containing medication (including vaginal oestrogens) 5. Prior endocrine therapy for breast cancer6. Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ) 7. Bilateral invasive disease (added 01/11/2016)8. Any severe coincident medical disease, including seizure disorder requiring medication 9. Diagnosis by FNA alone or excisional biopsy or lumpectomy performed prior to study entry10. Surgical axillary staging procedure prior to study procedure (with the exception of FNA or core biopsy)11. Definitive clinical or radiologic evidence of metastatic disease12. History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with radiotherapy or contralateral invasive breast cancer at any time13. New York Hearth Association classification of level III or IV heart disease14. Any treatment, including radiotherapy, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry15. Patients on established CYP3A inhibitors/inducers 16. QTc >480 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or know history of QTc prolongation, or Torsade de Pointes (TdP)17. Active Hepatitis B or Hepatitis C with abnormal liver function tests18. HIV positive patients receiving antivirals


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • ICR Clinical Trials and Statistics Unit
    15 Cotswold Road
    Sutton
    SM2 5NG

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Ms Katie Goddard



The study is sponsored by The Institute for Cancer Research and funded by Pfizer UK.




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: ISRCTN31243262
Last updated 16 January 2023

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.