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A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

PHASE3RECRUITING

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

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Study details:

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria.

Prior use of CDK4/6 inhibitors is permitted. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion 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

Exclusion 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 ≥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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-03-31

Primary completion: 2027-04-19

Study completion finish: 2036-05-29

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05774951

Intervention or treatment

DRUG: Camizestrant

DRUG: Tamoxifen

DRUG: Anastrozole

DRUG: Letrozole

DRUG: Exemestane

Conditions

• Breast Cancer, Early Breast Cancer

Image related to Breast Cancer, Early Breast Cancer

Condition: Breast Cancer, Early Breast Cancer
DRUG: Camizestrant and other drugs
Concord, Not Specified, Australia and more
Sponsor: AstraZeneca

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Find a site

Closest Location:

Research Site

Research sites nearby

Select from list below to view details:

Research Site
Concord, Not Specified, Australia
Research Site
Nedlands, Not Specified, Australia
Research Site
Randwick, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Arm A: standard endocrine therapy of investigator´s choice Continue standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen)	DRUG: Tamoxifen Tamoxifen. Comparator. Administered per local approved label
EXPERIMENTAL: Arm B: camizestrant Camizestrant	DRUG: Camizestrant Camizestrant. Experimental. Administered orally

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Invasive breast cancer-free survival (IBCFS)	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.	Up to 10 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Invasive disease-free survival (IDFS)	IDFS is defined as time from randomisation until date of first occurrence of one of the following events: * Invasive ipsilateral breast tumor recurrence (invasive IBTR) * Locoregional invasive breast cancer recurrence * Distant recurrence * Invasive contralateral breast cancer * Second primary non-breast invasive cancer * Death attributable to any cause.	Up to 10 years
Distant relapse-free survival (DRFS)	DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.	Up to 10 years
Overall survival (OS)	OS is defined as time from randomisation until death from any cause.	Up to 10 years
Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)	Not Specified	Until 28 days after the final dose of study treatment (up to 5 years)
Absolute and percent change from baseline in Clinical Laboratory Parameters	Not Specified	Until 28 days after the final dose of study treatment (up to 5 years)
Absolute and percent change from baseline in Vital Sign Parameters	Not Specified	Until 28 days after the final dose of study treatment (up to 5 years)
Number of participants with abnormal physical examinations	Not Specified	Until 28 days after the final dose of study treatment (up to 5 years)
Change from baseline of arthralgia as measured by the EORTC-IL-194 (European Organisation for Research and Treatment of Cancer) item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)	Not Specified	Until 28 days after the final dose of study treatment (up to 5 years)
Change from baseline of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)	Not Specified	Until 28 days after the final dose of study treatment (up to 5 years)
Change from baseline of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)	Not Specified	Until 28 days after the final dose of study treatment (up to 5 years)
Proportion of patients experiencing each level of symptomatic AEs of arthralgia as measured by the EORTC-IL-194 item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)	Not Specified	Until 28 days after the final dose of study treatment (up to 5 years)
Proportion of patients experiencing each level of symptomatic AEs of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)	Not Specified	Until 28 days after the final dose of study treatment (up to 5 years)
Proportion of patients experiencing each level of symptomatic AEs of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)	Not Specified	Until 28 days after the final dose of study treatment (up to 5 years)
Change from baseline and TTD (time to deterioration ) of health-related QoL (quality of life) as measured by the 2 global QoL items from the EORTC-QLQ-C30 items 11 and 12. EORTC-QLQ-C30 uses 0 - 4 scale (higher score is worse)	Not Specified	Until 28 days after the final dose of study treatment (up to 5 years)
Pharmacokinetics (PK)	• Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration)	Until 6 months from treatment start

Frequently Asked Questions

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References

Clinical Trials Gov: A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy