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A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy
EU CTIS ID: 2022-501024-20-00
What this study is testing
To demonstrate superiority of extended therapy with camizestrant over the standard endocrine therapy in preventing breast cancer recurrence
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 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)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Adequate organ and marrow function
You likely can't join if
- Inoperable locally advanced or metastatic breast cancer
- Any evidence of severe or uncontrolled systemic diseases which, in the investigator’s opinion precludes participation in the study or compliance
- Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.
- Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
- 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 or any of its excipients, that would preclude the patient from receiving any LHRH agonist
- Pathological complete response following treatment with neoadjuvant therapy
See the full eligibility 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 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)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Adequate organ and marrow function
- Inoperable locally advanced or metastatic breast cancer
- Any evidence of severe or uncontrolled systemic diseases which, in the investigator’s opinion precludes participation in the study or compliance
- Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.
- Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
- 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 or any of its excipients, 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
- Known LVEF <50% with heart failure NYHA Grade ≥2.
- Mean resting QTcF interval > 480 ms at screening congenital long QT syndrome, immediate family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
- Concurrent exogenous sex hormone therapy
- Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab)
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- Peru
- Thailand
- India
- Philippines
- Brazil
- Japan
- Korea, Republic of
- South Africa
- Chile
- Malaysia
- Georgia
- Argentina
- Turkey
- Singapore
- Vietnam
- Israel
- Australia
- Canada
- United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; Peru; Thailand; India; Philippines; Brazil and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.