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Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer

Trial Status: Active

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER Positive, HER2 Negative Advanced Breast Cancer (SERENA-1)

Inclusion Criteria

  • Inclusion 1. Signed written informed consent 2. >= 18 years 3. Any menopausal status: 1. Pre-menopausal women must have commenced treatment with an LHRH agonist at least 4 weeks prior to starting IMP (AZD9833 ± palbociclib, everolimus or abemaciclib) and must be willing to continue to receive LHRH agonist therapy for the duration of the study 2. Post-menopausal defined according to standard criteria in the protocol 4. Histological or cytological confirmation of adenocarcinoma of the breast 5. Documented positive oestrogen receptor status of primary or metastatic tumour tissue, according to the local laboratory parameters. HER-2 negative. 6. Metastatic disease or locoregionally recurrent disease which is refractory or intolerant to existing therapy(ies) known to provide clinical benefit 7. Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting IMP 8. Prior chemotherapy, endocrine therapy and other therapy as follows: 1. No more than 2 lines of chemotherapy for advanced disease 2. Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting 3. There is no limit on the number of lines of prior endocrine therapies 4. Prior treatment with CDK4/6 inhibitors is permitted 9. Women of childbearing potential must agree to use a highly effective contraceptive measure, must not be breast feeding, and must have a negative pregnancy test prior to the start of dosing 10. At least one lesion (measurable and/or non-measurable, as per RECIST 1.1 that can be accurately assessed at baseline and is suitable for repeated assessment by CT, MRI, or plain X-ray; or clinical examination. Blastic-only lesions in bone are not considered assessable 11. ECOG/ WHO performance status 0 to 1, with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks Inclusion criteria for the paired tumour biopsy research: 12. Disease suitable for paired baseline and on-study tumour biopsies 13. Washout from prior fulvestrant: 6 months 14. Washout from prior tamoxifen: 4 months 15. Signed written informed consent for tumour biopsies

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: systems coordinator
Phone: 215-214-1558

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

This is a multicentre dose escalation and expansion, first-in-human study designed to

evaluate the safety and tolerability of AZD9833, alone (Parts A and B) or in combination with

palbociclib (Parts C and D) or in combination with everolimus (Parts E and F) or in

combination with abemaciclib (Parts G and H), in women with endocrine-resistant ER+ HER2-

breast cancer that is not amenable to treatment with curative intent.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D8530C00001
  • Secondary IDs NCI-2019-03052, 2018-000667-92, 138396
  • Clinicaltrials.gov ID NCT03616587