2023-504031-41-00招募中3 期
CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) 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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,049
- 试验地点
- 246
- 主要终点
- Primary efficacy IBCFS (invasive breast cancer free-survival) as defined by STEEP 2.0 criteria
研究概览
简要总结
To demonstrate superiority of camizestrant ± abemaciclib as compared to standard endocrine therapy ± abemaciclib in preventing breast cancer recurrence
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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 either in the adjuvant orneoadjuvant setting prior to randomisation
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- •Adequate organ and marrow function
排除标准
- •Inoperable locally advanced or metastatic breast cancer
- •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
- •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
- •SUB-STUDY ONLY: Initiation of restricted medications prior to randomisation in main study. Patients assessed as not able to comply with study procedures, restrictions, and requirements
- •SUB-STUDY ONLY: Comorbidities or concomitant medications; ongoing skin conditions, bleeding of unknown aetiology that might impact assessment of sub-study objectives.
- •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
- •For PORTUGAL ONLY: Patients with known germline or somatic BRCA1/2 mutations.
研究组 & 干预措施
GOSERELIN
Auxiliary
干预措施: GOSERELIN (Drug)
EXEMESTANE
Comparator
干预措施: EXEMESTANE (Drug)
Camizestrant
Test
干预措施: Camizestrant (Drug)
TRIPTORELIN
Auxiliary
干预措施: TRIPTORELIN (Drug)
LEUPRORELIN ACETATE
Auxiliary
干预措施: LEUPRORELIN ACETATE (Drug)
Nolvadex® 20 mg Filmtabletten
Comparator
干预措施: Nolvadex® 20 mg Filmtabletten (Drug)
Arimidex® 1 mg Filmtabletten
Comparator
干预措施: Arimidex® 1 mg Filmtabletten (Drug)
ABEMACICLIB
Test
干预措施: ABEMACICLIB (Drug)
LETROZOLE
Comparator
干预措施: LETROZOLE (Drug)
结局指标
主要结局
Primary efficacy IBCFS (invasive breast cancer free-survival) as defined by STEEP 2.0 criteria
Primary efficacy IBCFS (invasive breast cancer free-survival) as defined by STEEP 2.0 criteria
次要结局
- Secondary efficacy IDFS(invasive disease-free survival) as defined by STEEP 2.0 criteria DRFS(distant relapse-free survival) as defined by STEEP 2.0 criteria OS(overall survival)
- Secondary safety Safety endpoints including: • TEAEs(treatment-emergent adverse event), SAEs(serious adverse event) • Clinical laboratory tests and vital signs
- Secondary COAs(clinical outcome assessment): Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT
- Secondary COAs (clinical outcome assessment) Change from baseline and TTD(time to deterioration ) of health-related QoL(quality of life) as measured by the 2 global QoL (quality of life) items from the EORTC IL-311 (European Organisation for Research and Treatment of Cancer)
- Secondary PK(pharmacokinetic(s) Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration)
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (246)
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