NIPH Clinical Trials Search

JRCT ID: jRCT2031230096

Registered date:26/05/2023

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBreast Cancer, Early Breast Cancer
Date of first enrollment31/07/2023
Target sample size430
Countries of recruitmentCzech 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 typeInterventional
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.


Primary OutcomeInvasive 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.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
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


Public contact
Name Kazushige Hibi
Address 3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-0011
Telephone +81-6-4802-3533
Affiliation Astrazeneca K.K
Scientific contact
Name Kazushige Hibi
Address 3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-0011
Telephone +81-6-4802-3533
Affiliation Astrazeneca K.K