Endometrial CancerPhase 2/3NCT05454358
Letrozole as Maintenance Therapy for Post-surgical Endometrial Cancer Patients With NSMP
A Phase 2/3 study testing Letrozole 2.5mg in people with Endometrial Cancer, run by Fudan University at 1 site in China.
Trial summary
Aim to investigate the effect of Letrozole as maintenance after adjuvant treatment on the prognosis of post-operative endometrial cancer patients with non-specific molecular profile. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Letrozole 2.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2022to 1 Dec 2025
- Phase
- Phase 2/3
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years old;
- Initial diagnosed with stage I-IV(FIGO2009) endometrial epithelial cancer, regardless of pathological types;
- Surgery must have included a hysterectomy, bilateral salpingo-oophorectomy and sentinel node biopsy; pelvic lymph node sampling and para-aortic lymph node sampling are optional;
- Life expectancy of 2 or more years.
- Confirmed NSMP with intermediate or higher prognostic risk according to post-operative clinical pathological assessment and molecular classification;
- Intermediate prognostic risk group:
Show all 30Show fewer
- Stage lB endometrioid + Iow-grade* + LVSI negative or focal
- Stage IA endometrioid + high-grade*+ LVSI negative or focal
- Stage IA non-endometrioid (serous, clear cell, undifferentiated carcinoma, carcinosarcoma, mixed) without myometrial invasion
- High-intermediate prognostic risk group:
- Stage I endometrioid + substantial LVSI, regardless of grade and depth of invasion
- Stage lB endometrioid high-grade*, regardless of LVSI status
- Stage II
- High prognostic risk group:
- Stage Ill-IVA with no residual disease
- Stage I-IVA non-endometrioid (serous, clear cell, undifferentiated carcinoma, carcinosarcoma, mixed) with myometrial invasion, and with no residual disease
- Advanced Metastatic:
- Stage III-IVA with residual disease
- Stage IVB Low grade: G1-2; High grade:G3;
- Received conventional adjuvant therapy after surgery according to the latest version of NCCN or ESGO/ESTRO/ESP guidelines;
- Patients with residual tumor after surgery (any single site) must have achieved complete response or partial response after post-operative adjuvant therapy;
- Expected start of letrozole maintenance within 3 months after adjuvant therapy;
- Adequate organ function as defined by the following criteria:
- White blood cell (WBC) ≥ 3000/μL or Absolute neutrophil count (ANC) ≥1500/μL
- Platelets ≥100,000/μL
- Serum Aspartate transaminase (AST) and/or serum alanine transaminase (ALT) ≤ 2 times upper limit of normal (ULN)
- Serum creatinine ≤2 times ULN
- Karnofsky score ≥60;
- Eastern Cooperative Oncology Group (ECOG) Performance status ≤2;
- Ability to take anti-thyroid drugs, calcium, vitamin D or bisphosphonates together.
Who cannot join
- Endometrial stromal tumor;
- Recurrent endometrial cancers;
- Patients with low prognostic risk according to post-operative clinical pathological assessment ( Stage IA endometrioid + low-grade* +LVSI negative or focal);
- Patients require no adjuvant therapy after surgery;
- Negative expression in estrogen receptor or progesterone receptor according to post-operative Immunohistochemistry;
- Received other adjuvant therapy within 6 months before surgery: including neoadjuvant therapy, hormone therapy, targeted therapy, immunotherapy and biotherapy, etc;
Show all 14Show fewer
- Patients with contraindications for letrozole;
- Patients with other malignant tumors;
- History of vital organ transplantation;
- History of immune disease and need to take immunosuppressor;
- Uncontrolled psychiatric illness or other situations that would limit compliance with study requirements;
- History of drug abuse;
- Participated in other clinical trials;
- No ability or intention to receive letrozole maintenance/sign the consent/obey the study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Letrozole as Maintenance Therapy Versus Observation After Adjuvant Treatment on the Prognosis for Post-surgical Endometrial Cancer Patients With Non-specific Molecular Profile: a Superiority Randomized Controlled Trial
Aim to investigate the effect of Letrozole as maintenance after adjuvant treatment on the prognosis of post-operative endometrial cancer patients with non-specific molecular profile.
Read the detailed description
This is an open label multi-center superiority randomized controlled trial, aimed to investigate the effect of Letrozole as maintenance therapy on the prognosis of post-operative endometrial cancer patients with non-specific molecular profile.
The molecular classification of non-specific molecular profile (NSMP) is the most common type of endometrial cancer. Reducing the recurrence rate and improving the survival rate in patients with NSMP can effectively improve the overall prognosis of endometrial cancer.
NSMP endometrial cancers are featured as high sensitivity to hormones, which could be a potential target to improve the prognosis. Antiestrogenic therapy might be an effective treatment to improve the prognosis of NSMP endometrial cancer with high risk of recurrence and metastasis.
Letrozole, an oral non-steroidal aromatase inhibitor, might have positive impact on those patients as maintenance therapy after first-line postoperative adjuvant treatments. The current standardized treatment for intermediate-high risk endometrial cancer patients after chemotherapy and radiotherapy includes none but observation alone. However, with little adverse effects, low cost and easy availability, the practice of letrozole in hormonally-responsive breast cancer after surgery added to evidence to have an improvement in the prognosis in intermediate-high risk endometrial cancer. Thus, it is necessary to carry out a randomized trial to investigate the role of letrozole as maintenance therapy after postoperative adjuvant treatment in the prognosis of intermediate-high risk endometrial cancer.
This study were approved by the Ethics Committees of Obstetrics and Gynecology Hospital of Fudan University and all other institutes. Before initiation of study procedures, written informed consent will be obtained from each patient regarding risks of treatments and agreement of using their clinical data for research purpose.
This is a multicentered, open-label, randomized clinical trial. Randomization will be carried out in each center. A computer-based procedure of simple randomization (SPSS for Mac, version 22.0; IBM ) will be used for participant enrollment and randomization. Before an individual is successfully enrolled, her treatment assignment will remain concealed. This trial will be open label: patients and study physicians were aware of treatment assignment.
Patients will be stratified into 3 groups by operative staging (FIGO 2009), pre- and post- operative imaging assessment and residual tumor condition after surgery: stage I/II without early postoperative residues, stage III/IV without late postoperative residues and patients with postoperative residues. Eligible patients in each stratification of each center will be randomly assigned (1:1) to receive:
Arm 1. Letrozole 0.5mg qd po for 2 years after postoperative adjuvant therapy, or Arm 2. Observation alone without any other therapy after postoperative adjuvant therapy.
A definitive surgery should be performed after the latest NCCN guidelines, including a hysterectomy with/without bilateral salpingo-oophorectomy plus sentinel node biopsy or pelvic lymph node sampling with para-aortic lymph node sampling.
All the patients must meet the criteria to have postoperative adjuvant treatments, excluding patients with low prognostic risk: stage IA endometrioid + low-grade* +lymphovascular space invasion (LVSI) negative or focal, or those requiring no adjuvant therapy after surgery. Postoperative adjuvant treatments are carried out following the latest NCCN or ESGO guidelines according to doctors' choice.
Molecular classification must be performed and proved be to non-specific molecular profile (NSMP) according to diagnostic algorithm for the integrated histomolecular endometrial carcinoma classification (WHO classification of tumors, 5th edition, female genital tumours).
Statistical analyses On the basis of data from previous studies (Molecular Classification of PORTEC-3 Trial；GOG-249；GOG-99), the 3-year PFS is expected to be 80% in the observation group. Letrozole as maintenance therapy would improve 3-year PFS to 90%, which is considered as superior to observation alone. An accrual of 299 patients in 3 years will provide the study with adequate power (90%) to detect a clinically relevant absolute difference of 10% in 3-year PFS (90% vs 80%) between both groups (one-sided test, a=0.05), with a lost follow up rate ≤10%. Analyses will be done firstly by intention to treat.
- Conditions
- Endometrial Cancer
- Being tested
- Letrozole 2.5mg
- Keywords
- endometrial cancer, letrozole, maintenance therapy, molecular classification, non-specific molecular profile
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole 2.5mgDrug
Also called Letrozole 2.5mg qd po for 2 years
Letrozole 0.5mg qd po for 2 years after postoperative adjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | Letrozole 0.5mg qd po for 2 years after postoperative adjuvant therapy Receives: Drug: Letrozole 2.5mg |
| Observation | No intervention | Observation alone without any other therapy after postoperative adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 3-year Progression-Free-Survival(PFS)
The percentage of patients who have first relapse within 3 years after surgery
Measured: 3 years
Secondary outcomes (5)
the 3-year Overall survival(OS)
The percentage of patients who died within 3 years after surgery.
Measured: 3 years
the 5-year PFS and OS
The percentage of patients who have first relapse within 5 years after surgery. The percentage of patients who died within 5 years after surgery.
Measured: 5 years
Incidence of adverse events
Adverse events related with intervention. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be recorded, as well as incidence of adverse events.
Measured: From date of recruitment, assessed up to 5 years
Quality of life change
Collect the questionnaire EORTC QLQ-C30 V3.0-EN24 and questionnaire MENQOL, and count scores change through intervention (Letrozole or Observation).
Measured: baseline, 1 year, and 2 years
Site of recurrence
The frequency of recurrence site in different groups.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start2 Aug 2022
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Why it stopped: No enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Obstetrics & Gynecology Hospital of Fudan University
- Responsible party
- Principal investigator, Xiaojun Chen, Fudan University
- Investigators
- Xiaojun Chen, Ph.D, M.D, Principal investigator, Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454358
- Sponsor's protocol ID
- 2022-54
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2022
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole as Maintenance Therapy Versus Observation After Adjuvant Treatment on the Prognosis for Post-surgical Endometrial Cancer Patients With Non-specific Molecular Profile: a Superiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05454358
- Acronym / sponsor ID
- 2022-54
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, letrozole, maintenance therapy, molecular classification, non-specific molecular profile
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No enough participants
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Obstetrics & Gynecology Hospital of Fudan University
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim to investigate the effect of Letrozole as maintenance after adjuvant treatment on the prognosis of post-operative endometrial cancer patients with non-specific molecular profile.
Detailed description
This is an open label multi-center superiority randomized controlled trial, aimed to investigate the effect of Letrozole as maintenance therapy on the prognosis of post-operative endometrial cancer patients with non-specific molecular profile.
The molecular classification of non-specific molecular profile (NSMP) is the most common type of endometrial cancer. Reducing the recurrence rate and improving the survival rate in patients with NSMP can effectively improve the overall prognosis of endometrial cancer.
NSMP endometrial cancers are featured as high sensitivity to hormones, which could be a potential target to improve the prognosis. Antiestrogenic therapy might be an effective treatment to improve the prognosis of NSMP endometrial cancer with high risk of recurrence and metastasis.
Letrozole, an oral non-steroidal aromatase inhibitor, might have positive impact on those patients as maintenance therapy after first-line postoperative adjuvant treatments. The current standardized treatment for intermediate-high risk endometrial cancer patients after chemotherapy and radiotherapy includes none but observation alone. However, with little adverse effects, low cost and easy availability, the practice of letrozole in hormonally-responsive breast cancer after surgery added to evidence to have an improvement in the prognosis in intermediate-high risk endometrial cancer. Thus, it is necessary to carry out a randomized trial to investigate the role of letrozole as maintenance therapy after postoperative adjuvant treatment in the prognosis of intermediate-high risk endometrial cancer.
This study were approved by the Ethics Committees of Obstetrics and Gynecology Hospital of Fudan University and all other institutes. Before initiation of study procedures, written informed consent will be obtained from each patient regarding risks of treatments and agreement of using their clinical data for research purpose.
This is a multicentered, open-label, randomized clinical trial. Randomization will be carried out in each center. A computer-based procedure of simple randomization (SPSS for Mac, version 22.0; IBM ) will be used for participant enrollment and randomization. Before an individual is successfully enrolled, her treatment assignment will remain concealed. This trial will be open label: patients and study physicians were aware of treatment assignment.
Patients will be stratified into 3 groups by operative staging (FIGO 2009), pre- and post- operative imaging assessment and residual tumor condition after surgery: stage I/II without early postoperative residues, stage III/IV without late postoperative residues and patients with postoperative residues. Eligible patients in each stratification of each center will be randomly assigned (1:1) to receive:
Arm 1. Letrozole 0.5mg qd po for 2 years after postoperative adjuvant therapy, or Arm 2. Observation alone without any other therapy after postoperative adjuvant therapy.
A definitive surgery should be performed after the latest NCCN guidelines, including a hysterectomy with/without bilateral salpingo-oophorectomy plus sentinel node biopsy or pelvic lymph node sampling with para-aortic lymph node sampling.
All the patients must meet the criteria to have postoperative adjuvant treatments, excluding patients with low prognostic risk: stage IA endometrioid + low-grade* +lymphovascular space invasion (LVSI) negative or focal, or those requiring no adjuvant therapy after surgery. Postoperative adjuvant treatments are carried out following the latest NCCN or ESGO guidelines according to doctors' choice.
Molecular classification must be performed and proved be to non-specific molecular profile (NSMP) according to diagnostic algorithm for the integrated histomolecular endometrial carcinoma classification (WHO classification of tumors, 5th edition, female genital tumours).
Statistical analyses On the basis of data from previous studies (Molecular Classification of PORTEC-3 Trial；GOG-249；GOG-99), the 3-year PFS is expected to be 80% in the observation group. Letrozole as maintenance therapy would improve 3-year PFS to 90%, which is considered as superior to observation alone. An accrual of 299 patients in 3 years will provide the study with adequate power (90%) to detect a clinically relevant absolute difference of 10% in 3-year PFS (90% vs 80%) between both groups (one-sided test, a=0.05), with a lost follow up rate ≤10%. Analyses will be done firstly by intention to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: Letrozole 2.5mgLetrozole 0.5mg qd po for 2 years after postoperative adjuvant therapy |
| Observation | No intervention | –Observation alone without any other therapy after postoperative adjuvant therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Older than 18 years old;
- Initial diagnosed with stage I-IV(FIGO2009) endometrial epithelial cancer, regardless of pathological types;
- Surgery must have included a hysterectomy, bilateral salpingo-oophorectomy and sentinel node biopsy; pelvic lymph node sampling and para-aortic lymph node sampling are optional;
- Life expectancy of 2 or more years.
- Confirmed NSMP with intermediate or higher prognostic risk according to post-operative clinical pathological assessment and molecular classification;
Key exclusion criteria (14 listed)
- Endometrial stromal tumor;
- Recurrent endometrial cancers;
- Patients with low prognostic risk according to post-operative clinical pathological assessment ( Stage IA endometrioid + low-grade* +LVSI negative or focal);
- Patients require no adjuvant therapy after surgery;
- Negative expression in estrogen receptor or progesterone receptor according to post-operative Immunohistochemistry;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole 2.5mgAlso: Letrozole 2.5mg qd po for 2 yearsLetrozole 0.5mg qd po for 2 years after postoperative adjuvant therapy | Drug | Letrozole |
Primary outcome
the 3-year Progression-Free-Survival(PFS)
Time frame: 3 years
The percentage of patients who have first relapse within 3 years after surgery
5 secondary outcomes
the 3-year Overall survival(OS)
Time frame: 3 years
the 5-year PFS and OS
Time frame: 5 years
Incidence of adverse events
Time frame: From date of recruitment, assessed up to 5 years
Quality of life change
Time frame: baseline, 1 year, and 2 years
Site of recurrence
Time frame: 8 years
Results and safety
The study was stopped early (reason given: No enough participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojun Chen, Ph.D, M.D principal investigator
Obstetrics & Gynecology Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Letrozole 2.5mg in people with Endometrial Cancer, run by Fudan University at 1 site in China.
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 30 inclusion and 14 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: stopped early, as of the sponsor's last update on 15 Dec 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 China. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: No enough participants). Results are not available in the source record.
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?
the 3-year Progression-Free-Survival(PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2025.