A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer

JRCT ID: jRCT2031230096

Registered date:26/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast Cancer, Early Breast Cancer
• Date of first enrollment: 31/07/2023
• Target sample size: 430
• Countries of recruitment: Czech Republic,Japan,France,Japan,Georgia,Japan,Germany,Japan,Hellenic Republic,Japan,Hungary,Japan,India,Japan,State of Israel,Japan,Italy,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,Peru,Japan,Philippines,Japan,Poland,Japan,Portuguese Republic,Japan,Romania,Japan,Republic of Serbia,Japan,Singapore,Japan,South Africa,Japan,Korea,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,United Kingdom,Japan,United states of America,Japan,Viet Nam,Japan
• Study type: Interventional

Intervention(s)

arm A: continue with SoC ET as directed by investigator until treatment discontinuation. Pre- or peri-menopausal female or male patients in the Arm A receiving standard ET (AI or tamoxifen) should receive concurrent LHRH agonist as medically applicable.

arm B: receive 150 mg oral, once daily until treatment discontinuation. All pre- or peri-menopausal female patients, and male patients, in Arm B (camizestrant) must receive a concurrent LHRH agonist (goserelin, leuprorelin, or triptorelin), per manufacturer's instructions.

Outcome(s)

Primary Outcome

Invasive breast cancer-free survival (IBCFS) [ Time Frame: Up to 10 years ]
IBCFS is defined as time from randomisation until date of first occurrence of:

- Invasive ipsilateral breast tumour recurrence (invasive IBTR)
- Locoregional invasive breast cancer recurrence
- Distant recurrence
- Invasive contralateral breast cancer
- Death attributable to any cause.

Key inclusion & exclusion criteria

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

Include criteria

- Women and Men, greater than or equal to 18 years at the time of screening (or per national guidelines)

- Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, 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

- Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)

- Prior adjuvant therapy with CDK4/6 inhibitors for 2 years is allowed

- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1

- Adequate organ and 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 at 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 greater than or equal to 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

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT05774951