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Estrogen Receptor-positivePhase 2CARANCT07840443

Phase II Study of CAmizestrant in Resectable Endometrial Adenocarcinoma

A Phase 2 study testing Camizestrant in people with Estrogen Receptor-positive and Early Stage Endometrial Cancer, run by University Health Network, Toronto at 6 sites in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a window of opportunity study designed to provide short duration exposure to camizestrant prior to planned curative intent surgery, with the anticipated benefit of demonstrating target engagement and suppression of ER signalling in ER positive endometrial cancer without delaying standard surgical management. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Camizestrant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
6 sitesCanada
Study dates
26 Oct 2026to 26 Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must provide informed consent prior to undergoing any study-specific procedures.
  • Only female participants aged 18 years or older are eligible for inclusion.
  • Participants must have a histologically confirmed, newly diagnosed, resectable endometrial adenocarcinoma with the following characteristics determined by local pathology:
  • ER positivity equal or greater than 10%
  • TP53 wildtype status by IHC.
  • Proficient mismatch repair (pMMR) by IHC
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  • Any histology and grade is acceptable
  • FIGO stage I-III
  • Female participants must have a newly diagnosed primary endometrial cancer and be scheduled for radical surgery, regardless of their clinical node status.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
  • Participants must have adequate bone marrow reserve and organ function as demonstrated by the following laboratory values:
  • Hemoglobin (Hb): > 80 g/L
  • Platelet count: > 100 × 10⁹/L
  • Creatinine < 1.5 × ULN
  • AST and ALT: < 3 × Upper Limit of Normal (ULN)
  • Total Bilirubin: < 1.5 × ULN
  • Participants must be post-menopausal, which can be clinically defined as 12 consecutive months without a menstrual period as reported by the patient in the absence of endocrine therapies or patient with bilateral oophorectomy.
  • Participants must be willing to provide pre-treatment baseline tumor tissue (from diagnostic biopsy) and tissue from the surgical procedure for biomarker analyses and blood samples for ctDNA analysis.

Who cannot join

  • Participants must not have received any previous systemic or local treatment for the new primary endometrial cancer currently under investigation. This includes surgery, radiotherapy, cytotoxic treatments, and endocrine therapies.
  • Participants must not have had any of the following interventions:
  • Use of sex-hormone-containing drugs within one month prior to the first dose of study treatment and concurrent use of hormonal treatments (such as for menopausal symptoms).
  • Medicinal products that are sensitive substrates (e.g. omeprazole) or substrates with narrow therapeutic index of CYP2C9 and/or CYP2C19 (e.g. warfarin and phenytoin) should be stopped at least 2 weeks before the first dose of camizestrant.
  • Strong CYP3A4/5 inducers (e.g. carbamazepine ) should be should be stopped at least 2 weeks before the first dose of camizestrant (3 weeks for St John's Wort)
  • Use of drugs known to prolong the QT interval and carry a known risk of torsades de pointes within the timeframe indicated in Table 5 (Appendix D) prior first dose of camizestrant.
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  • Ivabradine or other drugs with a similar mechanism of action in sinoatrial cells.
  • Participants must not have any evidence of severe or uncontrolled systemic diseases that, in the investigator's opinion, would make participation in the study undesirable.
  • Participants must not meet any of the following cardiovascular criteria:
  • Electrolyte Abnormalities: Untreated serum or plasma potassium, magnesium, or calcium levels outside the normal limit range that could prolong the QT interval. These are: clinically significant electrolyte abnormalities with potential QT-prolonging effect including hypokalaemia, hyperkalaemia, hypo- and hyper-magnesaemia, hypo- and hyper-calcaemia.
  • ECG Abnormalities:
  • Mean resting QTcF interval > 460 milliseconds at screening
  • Bradycardia (heart rate < 60 bpm)
  • Clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG, such as second- or third-degree heart block, clinically significant sinus pause or sinoatrial block, other sinus node dysfunction, or bundle branch block. Patients with pacemakers or medically controlled atrial fibrillation are not excluded. Note: A digital triplicate ECG is mandated during screening
  • Any other condition that increase the risk of QTc prolongation or the risk of arrhythmic events such as symptomatic heart failure, congenital long QT syndrome, immediate family history of long QT syndrome and unexplained sudden death at <40 years of age, hypertrophic cardiomyopathy and clinically significant stenotic valve disease.
  • Participants must not have experienced unexplained syncope within the six months prior to randomization, ongoing symptomatic hypotension, or ongoing asymptomatic hypotension with systolic blood pressure less than 90 mmHg.
  • Patients with pacemakers or medically controlled atrial fibrillation are not excluded.
  • Participants must not have a known left ventricular ejection fraction less than 50% and/or heart failure classified as NYHA Grade greater than or equal to 2.
  • Participants must not have uncontrolled hypertension, defined as systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 90 mmHg despite optimal medical management. Hypertensive patients may be eligible if blood pressure is adequately controlled at baseline.
  • Participants must not have experienced any cardiovascular procedure or event within the last 6 months such as: Coronary artery bypass graft, angioplasty, vascular stent placement, other structural heart disease interventions (e.g., cardiac valve repair or replacement surgery or transcatheter valve treatment), severe aortic regurgitation (Grades 3 and 4), myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack.
  • Participants must not have refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, an inability to swallow the formulated product, or a history of significant bowel resection that would preclude adequate absorption of camizestrant.
  • Participants must not have a history of hypersensitivity to any active or inactive excipients of camizestran
  • Participants must not be enrolled if, in the investigator's judgment, they are unlikely to comply with study procedures, restrictions, and requirements.
  • Pregnant patients or breastfeeding

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stephanie Lheureux, MD, PhD contact

416-946-2818

stephane.lheureux@uhn.ca

6 sites in 1 country

Canada6 sites

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

    Rania Chehade, MD, FRCPC

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

    Lara De Guerke, MD

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Susie Lau, MD

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

    Johanne Weberpals, MD

  • Princess Margaret Cancer Centre/University Health Network

    Toronto, Ontario, M5G 2M9

    Stephanie Lheureux, MD, PhD

  • BC Cancer - Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Yvette Drew, FRCPC, MBBS, PhD

    Yvette Drew, FRCPC, MBBS, PhD

Other trials in Canada

About this study

Official title: Phase II Window-of-Opportunity Study Evaluating the Pharmacodynamic Effects of Camizestrant in Early-Stage Estrogen Receptor-Positive Endometrial Cancer

This is a window of opportunity study designed to provide short duration exposure to camizestrant prior to planned curative intent surgery, with the anticipated benefit of demonstrating target engagement and suppression of ER signalling in ER positive endometrial cancer without delaying standard surgical management.

Being tested
Camizestrant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CamizestrantDrug

    Camizestrant is an oral selective ER antagonist and degrader

Study groups in NCT07840443
Study groupRoleWhat they receive
CamizestrantExperimentalCamizestrant 75mg QD for 4 weeks (+/- 2 weeks) prior to surgery
Receives: Drug: Camizestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change in in ER expression by H-score

    Measured: 2 years

  2. Percentage change in ER expression by H-score

    Measured: 2 year

Secondary outcomes (8)

  1. Absolute change in in PR expression by H-score

    Measured: 2 years

  2. Percentage change in PR expression by H-score

    Measured: 2 years

  3. Absolute change in Ki-67 by IHC scoring

    Measured: 2 years

  4. Percentage change in Ki-67 by IHC scoring

    Measured: 2 years

  5. Pathological response rate

    Measured: 2 years

  6. Plasma concentration of camizestrant at the time of surgery

    Measured: 2 years

  7. Number of participants with any AE/SAE from first dose through safety follow-up

    Measured: 2 years

  8. Percentage of participants with any AE/SAE from first dose through safety follow-up

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2026
  2. Study start26 Oct 2026 (estimated)
  3. Primary completion26 Oct 2028 (estimated)
  4. Study completion26 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07840443
Sponsor's protocol ID
OZUHN-050
Acronym
CARA
Status last verified
Sep 2026
First submitted
18 Sep 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camizestrant in people with Estrogen Receptor-positive and Early Stage Endometrial Cancer, run by University Health Network, Toronto at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephanie Lheureux, MD, PhD (416-946-2818, stephane.lheureux@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change in in ER expression by H-score (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07840443.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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