ClinicalTrials.gg
Not yet recruitingNCT07840443CARAUpdated Sep 25, 2026

Phase II Study of CAmizestrant in Resectable Endometrial Adenocarcinoma

A Phase 2 interventional study of Camizestrant in Estrogen Receptor-positive and Early Stage Endometrial Cancer, sponsored by University Health Network, Toronto. Not yet recruiting at 6 sites in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 127 studies in Endometrial Neoplasms with a site in Canada — 36 open to participants now, 58 under way, 17 of them phase 3. Endometrial Neoplasms · Canada.

Planned enrollment
97th of 109
30 · median 156
Started
2026
with 5 others
Phase 2
34 of 127
8 open now
Primary completion
2028-10
later than 43 of 57 live
Registered
127th of 127
by date
Lead sponsor
9 of 127
University Health Network, Toronto

Among the 127 studies in Endometrial Neoplasms with a site in Canada, this one is the 97th largest by planned enrollment of the 109 interventional ones, is one of 6 that started in 2026, is one of 34 in phase 2, reaches primary completion later than 43 of the 57 other live ones, and was the 127th registered.

By phase

127 studies; the count open now beside each. This study's row is marked.

Phase 2this study34 · 8 open
Phase 328 · 8 open
Phase 120 · 2 open
No phase17 · 6 open
Phase 1/214 · 5 open
Observational11 · 6 open
Phase 2/32 · 1 open
Phase 41 · 0 open

By the year they started

First in 1988; this study’s year is marked. 6 started in 2026.

Size and results

Median enrollment 156 across the 109 interventional studies, 212 across the 11 observational. Of the 65 that completed or were terminated, 16 (25%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 127 studies in Endometrial Neoplasms with a site in Canada, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Estrogen Receptor-positive
  • Early Stage Endometrial Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must provide prior to undergoing any study-specific procedures.
  • Only female participants aged 18 years or older are eligible for inclusion.
  • Participants must have a confirmed, newly diagnosed, resectable endometrial adenocarcinoma with the following characteristics determined by local pathology:

    1. ER positivity equal or greater than 10%
    2. TP53 wildtype status by IHC.
    3. Proficient mismatch repair (pMMR) by IHC
    4. Any histology and grade is acceptable
    5. 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 (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:

    1. (Hb): > 80 g/L
    2. count: > 100 × 10⁹/L
    3. Creatinine \< 1.5 ×
    4. and ALT: \< 3 × Upper Limit of Normal (ULN)
    5. Total : \< 1.5 × ULN
  • Participants must be , 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 ) and tissue from the surgical procedure for biomarker analyses and blood samples for ctDNA analysis.

Exclusion criteria

Exclusion Criteria:

  • 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:

    1. 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).
    2. 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.
    3. Strong /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)
    4. Use of drugs known to prolong the and carry a known risk of torsades de pointes within the timeframe indicated in Table 5 (Appendix D) prior first dose of camizestrant.
    5. 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:

    1. Electrolyte Abnormalities: Untreated serum or plasma potassium, magnesium, or calcium levels outside the normal limit range that could prolong the QT interval. These are: electrolyte abnormalities with potential QT-prolonging effect including hypokalaemia, hyperkalaemia, hypo- and hyper-magnesaemia, hypo- and hyper-calcaemia.
    2. 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.

    c. 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.

    d. Patients with pacemakers or medically controlled atrial fibrillation are not excluded.

    e. Participants must not have a known less than 50% and/or heart failure classified as Grade greater than or equal to 2.

    f. 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.

    g. 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 .

  • Participants must not have 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 to any active or inactive 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
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Camizestrant

    Camizestrant 75mg QD for 4 weeks (+/- 2 weeks) prior to surgery

    Drug: Camizestrant

Interventions

  • Camizestrant is an oral selective ER antagonist and degrader

06

What researchers measure

Primary outcomes

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

    Time frame: 2 years

  2. Percentage change in ER expression by H-score

    Time frame: 2 year

Secondary outcomes

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

    Time frame: 2 years

  2. Percentage change in PR expression by H-score

    Time frame: 2 years

  3. Absolute change in Ki-67 by IHC scoring

    Time frame: 2 years

  4. Percentage change in Ki-67 by IHC scoring

    Time frame: 2 years

  5. Pathological response rate

    Time frame: 2 years

  6. Plasma concentration of camizestrant at the time of surgery

    Time frame: 2 years

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

    Time frame: 2 years

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

    Time frame: 2 years

07

Study locations

6 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.

Of 107 non-industry phase 2 interventional studies under Endometrial Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 115. This study's planned 24 months is below that.

Counting every sponsor, half of 139 studies reached it within 55 months; a quarter within 37 and three quarters within 115.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2026
First posted
Sep 25, 2026
StartEst.
Oct 26, 2026
Primary completionEst.
Oct 26, 2028
CompletionEst.
Oct 26, 2028
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07840443
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Oct 26, 2026 (estimated)
Primary completion
Oct 26, 2028 (estimated)
Completion
Oct 26, 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Stephanie Lheureux, MD, PhD
Contact
stephane.lheureux@uhn.ca
416-946-2818
Stephanie Lheureux, MD, PhD
principal investigator · Princess Margaret Cancer Centre/University Health Network

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: AZD9833

Start the discussion