AZ, D8535C00001, Ph 3, Rand, Breast cancer, AZD9833 vs SOC

What is the Purpose of this Study?

Primary Objective: To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of invasive breast cancer-free survival (IBCFS). Secondary Objectives: To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of invasive disease-free survival (IDFS). To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of distant relapse-free survival (DRFS). To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of overall survival (OS). To demonstrate superior tolerability of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of the proportion of time on study treatment with high side-effect burden. To assess patient-reported treatment-associated symptoms of arthralgia, hot flush, and vaginal dryness of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib. To assess patient-reported health-related QoL in patients treated with camizestrant ± abemaciclib as compared to standard ET ± abemaciclib. To assess the steady-state PK of camizestrant in patients who received at least 1 dose of camizestrant per the protocol, for whom there is at least 1 reportable PK concentration.

Eligibility

* Women and Men; ≥18 years at the time of screening (or per national guidelines)
* Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.
* Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.
* Patients must be randomised within 12 months of definitive breast surgery.

Inclusion Criteria:

* Women and Men; ≥18 years at the time of screening (or per national guidelines)
* Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.
* Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.
* Patients must be randomised within 12 months of definitive breast surgery.
* Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Adequate organ and bone marrow function

Exclusion Criteria:

* Inoperable locally advanced or metastatic breast cancer
* Pathological complete response following treatment with neoadjuvant therapy
* History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
* Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance "
* Known LVEF \<50% with heart failure NYHA Grade ≥2.
* Mean resting QTcF interval \> 480 ms at screening
* Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
* Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)
* Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
* Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.
* Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.

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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Nikki Kem-Bernard

More about this Clinical Trial

What is the full name of this clinical trial?

D8535C00001 CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant Versus Standard Endocrine Therapy as Adjuvant Treatment for Patients with ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

Study Details

Disease Type/Condition

Breast

Principal Investigator

Bitar, Jin Sun

Co-Investigators

Alice Chung, Amin Mirhadi, Andrew Horodner, Armando Giuliano, Catherine Dang, David Chan, Farin Amersi, Hugo Hool, Justin Wayne Tiulim, Michele Burnison, Scott Karlan, Stephen Shiao, Swati Sikaria, Syed Jilani, Thomas Lowe, Vanessa Dickey, Yuan Yuan

Age Group

Adult

Phase

III

IRB Number

STUDY00003145

ClinicalTrials.gov ID

NCT05952557

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Nikki Kem-Bernard

Nikki.Bernard@cshs.org