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Clinical Trial Summary

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)


Clinical Trial Description

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 (± anastrozole) (Parts G and H), or in combination with capivasertib (Parts I and J), or in combination with ribociclib (± anastrozole) (Parts K and L), or in combination with anastrozole (Parts M and N) in women with endocrine-resistant ER+ HER2- breast cancer that is not amenable to treatment with curative intent. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03616587
Study type Interventional
Source AstraZeneca
Contact
Status Active, not recruiting
Phase Phase 1
Start date October 11, 2018
Completion date September 30, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04541433 - A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer Phase 1
Completed NCT02248090 - AZD9496 First Time in Patients Ascending Dose Study Phase 1
Terminated NCT03596658 - SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer Phase 1
Recruiting NCT06188520 - A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors Phase 1/Phase 2