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Endometrial CancerPhase 2NCT02730429

Trial of Letrozole + Palbociclib/Placebo in Metastatic Endometrial Cancer

A Phase 2 study testing Letrozole in people with Endometrial Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized double-blind, placebo-controlled phase 2 trial is evaluating superiority of Letrozole-palbociclib combination versus letrozole-placebo combination in ER positive endometrioid adenocarcinoma of endometrium Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Letrozole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 siteDenmark
Study dates
15 Feb 2017to 15 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histological confirmed endometrial cancer of endometrioid type. Mixed tumor histology is allowed if the non-endometrioid component is less than 5%. Tumor must be estrogen receptor positive.
  • Patients may have received adjuvant chemotherapy for stage 1 or 2.
  • Patients may have received any lines of chemotherapy for primary advanced (stage 3-4) or relapsed disease.
  • Patients may have received external beam radiotherapy, brachytherapy, and surgery.
  • Patient may have received maximum one line of endocrine therapy containing MPA/Megace only.
  • Patients must have measureable disease or evaluable disease on CT scan according to RECIST 1.1 outside irradiated field.
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  • Patients must give informed consent
  • Patients must have a WHO performance status of 0-1
  • Patients must have an adequate bone-marrow, renal and hepatic function
  • Life expectancy of at least 12 weeks
  • Patients must be fit to receive combination therapy
  • Patient's age >18 years
  • Patient is post-menopausal. Patients under the age of 55 with intact ovaries shall undergo hormonal verification.
  • Patients with preserved reproductive capacity must have a negative pregnancy test (β-HCG test in urine or serum) prior to commencing study treatment

Who cannot join

  • Non-endometrioid adenocarcinomas, sarcomas, small cell carcinoma with neuroendocrine differentiation or non-epithelial cancers.
  • Previous anti-cancer endocrine therapy other than MPA/Megace. This means that eg. tamoxifen is not allowed prior to study entry.
  • Concurrent cancer therapy
  • Previous treatment with Palbociclib or other CDK inhibitors.
  • Concurrent treatment with an investigational anticancer agent or participation in another anticancer clinical trial within 21 days before entering into study.
  • Treatment within 21 days prior to randomization with any investigational drug, radiotherapy,
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  • Major injuries or surgery within the past 21 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period.
  • Previous malignant disease, except patients with other malignant disease, for which the patient has been disease-free for at least three years. Concurrent other malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
  • Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed.
  • Evidence of significant medical illness, abnormal laboratory finding or psychiatric illness/social situation that would, in the Investigator's judgment, makes the patient inappropriate for this study.
  • Known uncontrolled hypersensitivity to the investigational drugs.
  • History of major thromboembolic event defined as:
  • History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 3 months.
  • History of clinically significant hemorrhage in the past 3 months.
  • Uncontrolled and/or symptomatic CNS metastasis or leptomeningeal carcinomatosis (dexamethasone/prednisone therapy will be allowed if administered as stable dose for at least one month prior randomization).
  • Significant cardiovascular diseases, including uncontrolled hypertension, uncontrolled clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months prior to randomization, congestive heart failure > NYHA III, severe peripheral vascular disease, clinically significant pericardial effusion.
  • Pregnancy or breastfeeding. Patients with preserved reproductive capacity, unwilling to use a medically acceptable method of contraception for the duration of the trial and for 3 months afterwards.
  • Active or chronic hepatitis C and/or B infection
  • Persistence of clinically relevant grade 3-4 therapy related toxicity from previous chemo and/or radiotherapy
  • Known hypersensitivity to the trial drugs, or to their excipients.
  • Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
  • Unable or unwilling to swallow tablets/capsules

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • NSGO-CTU

    Copenhagen, Region Sjælland, 2100

Other trials in Denmark

About this study

Official title: ENGOT-EN3-NSGO/PALEO: A Randomized, Double-blind, Placebo-controlled, Phase II Trial of Palbociclib in Combination With Letrozole Versus Placebo in Combination With Letrozole for Patients With Estrogen Receptor Positive Advanced or Recurrent Endometrial Cancer.

This randomized double-blind, placebo-controlled phase 2 trial is evaluating superiority of Letrozole-palbociclib combination versus letrozole-placebo combination in ER positive endometrioid adenocarcinoma of endometrium

Read the detailed description

This multicenter, prospective, randomized, double-blind, placebo-controlled phase 2 study is evaluating the efficacy of letrozole-palbociclib combination against letrozole-placebo combination in women with ER+ advanced or relapsed endometrial cancer.

Stratification

Patients are stratified according to:

  1. Number of prior lines of therapy (primary advanced disease vs. 1st relapse vs. ≥2 relapses)
  2. Measurable vs. evaluable disease
  3. Prior use of MPA/Megace

Randomization 1:1 randomization The patients with prior MPA/Megace treatment will be capped to a maximum of 50%.

Study arms

Patients are randomized to one of the two treatment arms:

  • Arm A: (comparator) letrozole-placebo combination therapy until progression.
  • Arm B: (experimental arm): Letrozole- palbociclib combination therapy until progression
Being tested
Palbociclib/placebo, Letrozole
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • Palbociclib/placeboDrug

    Palbociclib or a placebo is administered together with standard of care letrozole

  • LetrozoleDrug

    Letrozole is standard of care in both arms

Study groups in NCT02730429
Study groupRoleWhat they receive
Letrozole + placeboPlacebo comparatorletrozole 2.5mg once daily days 1-28 every 28 days shall be administered until progression of disease or unacceptable toxicity. Letrozole is administered as standard of care in both study arms. Placebo for palbociclib once daily days 1-21 every 28 days shall be administered until progression of disease or unacceptable toxicity.
Receives: Drug: Letrozole
Letrozole + palbociclibExperimentalPalbociclib 125mg once daily days 1-21 every 28 days shall be administered until progression of disease or unacceptable toxicity. letrozole 2.5mg once daily days 1-28 every 28 days shall be administered until progression of disease or unacceptable toxicity. Letrozole is administered as standard of care in both study arms.
Receives: Drug: Palbociclib/placebo; Drug: Letrozole

What is being measured

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

  1. Progression-Free Survival (PFS). Increase in median PFS in experimental arm versus comparator arm

    To be measured (in months) and reported

    Measured: 26 months

Secondary outcomes (10)

  1. PFS of patients in the sub-populations as described under stratification factors. Increase in median PFS in experimental arm versus comparator arm

    To be measured (in months) and reported

    Measured: 26 months

  2. Overall Response Rate (ORR) according to RECIST

    To be measured (in %) and reported

    Measured: 26 months

  3. Disease Control Rate (DCR) for at least 12 weeks

    To be measured (in %) and reported

    Measured: 26 months

  4. Time to First Subsequent Therapy (TFST)

    TFST: time from randomization to first subsequent therapy or death. To be measured (in months) and reported

    Measured: 36 months

  5. Progression-Free Survival 2 (PFS2)

    PFS2: time from randomization to second objective disease progression or death. To be measured (in months) and reported

    Measured: 48 months

  6. Time to Second Subsequent Therapy (TSST)

    TSST: time from randomization to second subsequent therapy or death.To be measured (in months) and reported

    Measured: 48 months

  7. Patient Reported Outcomes (PROs) like Quality of Life questionnaire EORTC-QLQ-C30 & EORTC-QLQ-EN24

    These are the validated questionnaires to be answered by patients. Results to be reported as descriptive and on a scale of 1-10

    Measured: 48 months

  8. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    To be reported on %

    Measured: 48 months

  9. Compliance in the two treatment arms.

    Missed dosages in both arm will be reported.

    Measured: 48 months

  10. Dose reductions/interruptions in the two treatment arms

    To be reported on %

    Measured: 48 months

Timeline

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

  1. First posted6 Apr 2016 (estimated)
  2. Study start15 Feb 2017
  3. Primary completion15 Dec 2020
  4. Study completion15 Dec 2021

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
Randomised
Intervention model
Parallel groups
Model description
randomized, double-blind, placebo-controlled
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02730429
Sponsor's protocol ID
ENGOT-EN3-NSGO/PALEO
Status last verified
Jul 2025
First submitted
14 Jan 2016
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: As all endpoints are matured, the individual participant data will be shared.

Publications

  • Mirza MR, Bjorge L, Marme F, Christensen RD, Gil-Martin M, Auranen A, Ataseven B, Rubio MJ, Salutari V, Luczak AA, Runnebaum IB, Redondo A, Lindemann K, Trillsch F, Ginesta MPB, Roed H, Kurtz JE, Petersson KS, Nyvang GB, Sehouli J. Palbociclib plus letrozole in estrogen receptor-positive advanced/recurrent endometrial cancer: Double-blind placebo-controlled randomized phase II ENGOT-EN3/PALEO trial. Gynecol Oncol. 2025 Jan;192:128-136. doi: 10.1016/j.ygyno.2024.12.003. Epub 2024 Dec 9.

    PubMed 39657575

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Letrozole in people with Endometrial Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 1 site in Denmark.

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 14 inclusion and 22 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: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS). Increase in median PFS in experimental arm versus comparator arm (time frame: 26 months). 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 NCT02730429, which also lists 1 linked publication.

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 31 Jul 2025.

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