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

JRCT ID: jRCT2061230074

Registered date:11/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast Cancer, Early Breast Cancer
• Date of first enrollment: 06/03/2024
• Target sample size: 550
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Croatia,Japan,Colombia,Japan,Czech Republic,Japan,Estonia,Japan,France,Japan,State of Israel,Japan,Georgia,Japan,Germany,Japan,Hellenic Republic,Japan,Hungary,Japan,India,Japan,Ireland,Japan,Italy,Japan,Malaysia,Japan,Mexico,Japan,New Zealand,Japan,Peru,Japan,Philippines,Japan,Poland,Japan,Portuguese Republic,Japan,Romania,Japan
• Study type: Interventional

Intervention(s)

arm A: continue with SoC ET as directed by investigator +- abemaciclib until treatment discontinuation. Pre- and peri-menopausal women and men will be treated with either an AI or tamoxifen per investigator's preference. In pre- and perimenopausal women, concurrent use of an LHRH agonist with either AI or tamoxifen is mandatory. In men, an LHRH agonist is mandatory with AI.

arm B: receive 75 mg AZD9833, oral, once daily +- abemaciclib until treatment discontinuation.Pre- and peri-menopausal women and men will require concurrent use of an LHRH agonist.

Outcome(s)

Primary Outcome

Invasive breast cancer-free survival (IBCFS) [ Time Frame: Up to 14 years ]
IBCFS is defined as time from randomisation until date of first occurrence of:

Invasive ipsilateral breast tumour recurrence
Locoregional invasive breast cancer recurrence
Distant recurrence
Contralateral invasive breast cancer
Death attributable to any cause.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

- Women and Men; 18 years or more 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 or less

- Adequate organ and bone marrow function

Exclude 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 or more.

- 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.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT05952557