A Phase I Study in Women with ER Positive, HER2 Negative Breast Cancer
Research type
Research Study
Full title
A Phase I Dose Escalation and Expansion Study of AZD9833 Alone or in Combination with Palbociclib in Women with ER Positive, HER2 Negative Advanced Breast Cancer
IRAS ID
250367
Contact name
Richard Baird
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-000667-92
Duration of Study in the UK
1 years, 7 months, 25 days
Research summary
AstraZeneca is doing this research to find out if the medication called AZD9833 alone and with palbociclib is safe for the treatment of the advanced breast cancer.
AZD9833 is not approved by any health authority, except for use in research studies like this. Palbociclib is an approved treatment for advanced metastatic breast cancer.
The study is planned to go on for 2 years and 6 months. It will include around 240 Patients.
Eligible patients: Pre-menopausal and Post-menopausal women aged 18 years or more, with advanced positive oestrogen receptor status and HER-2 negative breast cancer.
Patients must have had no more than 2 lines of prior chemotherapy, recurrence or progression on at least one line of endocrine therapy. There’s no limit on the number of lines of prior endocrine therapies. Prior treatment with CDK4/6 inhibitors is permitted.
The study medication and study assessments will depend on which part of the study the patient takes part in. There are four parts; A, B, C and D. A treatment cycle will last 28 days. On the first day of cycle 1 the patient will be asked to stay overnight. For cycle 2 the patient will have to attend 2 visits. After this, the patient will have 1 visit at the beginning of each treatment cycle for as long as they take the study medication.
During the visits tests and examinations will be performed depending on the type of visit. These may include: Physical examination, how easily the patient can perform the activities of your daily life. Blood pressure, pulse and cardiac function will be monitored. A record of medications the patient is taking and changes in symptoms. Blood and urine samples for routine, and non-routine laboratory tests. An assessment and measurement of the patients tumour by CT, MRI or X-Ray.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0285
Date of REC Opinion
13 Nov 2018
REC opinion
Further Information Favourable Opinion