SERENA-4: A Randomised, Double-Blind, Phase III Study of AZD9833 plus Palbociclib versus Anastrozole plus Palbociclib in Patients with ER-Positive HER2-Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

About this Study

The study is intended to show how safe and effective the combination of AZD 0933 with palbociclib is in treating advanced/metastatic breast cancer in comparison to alternative, Standard or Care treatment (anastrozole in combination with palbociclib).

Sponsor Protocol ID:D8532C00001
IRB Number:2021V0786
Actively Enrolling
Interventional
Phase 3
March 30, 2022
Eligibility Criteria
18 years old
Both Male and Female
Yes
No
Yes

Inclusion Criteria
  • Female or male, 18 years or older
  • Diagnosis of ER positive, HER2 negative breast cancer who cancer can not be cured by surgery or radiation therapy
  • Previously untreated with any systemic cancer therapy for locoregionally recurrent or metastatic ER positive disease
  • Must have (a) at least on lesion, not previously irradiated (b) OR in absence of measurable disease
  • New stage 4 disease or recurrent from early stage disease after adjuvant endocrine therapy
  • Willingness to use 2 non-hormonal based methods of contraception throughout the study

Exclusion Criteria
  • Have advance, symptomatic, visceral spread, that are at risk of life-threatening complication
  • Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
  • History of another cancer
  • Active known primary immunodeficiency, known HIV infection, or active hepatitis B or C infection
  • Previous neoadjuvant or adjuvant treatment with an AI treatment with disease recurrence while on or within 12 months of completing treatment
  • Any concurrent anti-cancer treatment
  • Palliative radiotherapy with a limited field of radiation within 2 weeks
  • Major surgical procedure or significant traumatic injury within 4 weeks of the first does of study treatment or an anticipated need for major surgery and/or any surgery requiring general anesthesia during the study
  • Participation in another clinical study with study treatment or investigational medicinal device administered in the last 4 weeks prior to randomization or concurrent enrollment in another clinical study
  • Known hypersensitivity to anastrozole

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Cancer
Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Jessica Solise
Phone Number: 601-984-1963
Email: jsolise@umc.edu
Principal Investigator:Tang, Shou-Ching, M.D.Ph.D., M.D., Ph.D.
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