A phase II randomised study evaluating the biological and clinical effects of the combination of palbociclib with letrozole as neoadjuvant therapy in post-menopausal women with ER+ primary breast cancer

The Institute for Cancer Research0 sites306 target enrollmentJanuary 9, 2015

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Post-menopausal patients with ER+ and HER2- primary breast cancer
Sponsor: The Institute for Cancer Research
Enrollment: 306
Status: Completed
Last Updated: 3 years ago

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

Registry

who.int

Start Date

January 9, 2015

End Date

March 3, 2020

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Postmenopausal women defined as:
•1\.1\. Age 56 or older with no spontaneous menses for at least 12 months prior to study entry
•1\.2\. Age 55 or younger with no menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented oestradiol level in the postmenopausal range according to local institutional/laboratory standard
•1\.3\. Age \=16 with documented bilateral oophorectomy
•2\. Operable ER\+ HER2\- invasive early breast cancer suitable for neoadjuvant AI treatment. ER positivity is defined as an Allred score of 3 (or equivalent) \[sentence added 01/11/2016]. HER2 negativity will be defined as per the 2013 ASCO/CAP guidelines as follows:
•2\.1\. IHC 1\+ as defined by incomplete membrane staining that is faint/barely perceptible and within \>10% of the invasive tumour cells
•2\.2\. IHC 0 as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within \=10% of the invasive tumour cells
•2\.3\. ISH negative based on:
•2\.3\.1\. Single\-probe average HER2 copy number \<4\.0 signals/cell
•2\.3\.2\. Dual\-probe HER2/CEP17 ratio \<2\.0 with an average HER2 copy number \<4\.0 signals/cell

•1\. Premenopausal or perimenopausal women
•2\. Inflammatory/inoperable breast cancer
•3\. 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 cancer
•6\. 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 entry
•10\. Surgical axillary staging procedure prior to study procedure (with the exception of FNA or core biopsy)