Trial · NCT05872204
Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer
NCT05872204, Phase 2, Recruiting, Universitaire Ziekenhuizen KU Leuven
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer. Trials, record NCT05872204. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05872204
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer
- NCT number
- NCT05872204
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Conditions
- Low Grade Serous Ovarian Carcinoma, Adult Type Granulosa Cell Tumor
- Interventions
- Abemaciclib, Letrozole
- First posted
- 2023-05-24
- Last updated
- 2026-05-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The overall response rate (ORR) of the combination of abemaciclib and letrozole, according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | Week 24 | RECIST is a standard system to measure how cancer responds to different treatments, including chemotherapy, immunotherapy, and radiation therapy. |
| Primary | The overall response rate (ORR) of the combination of abemaciclib and letrozole, according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | 3 years | RECIST is a standard system to measure how cancer responds to different treatments, including chemotherapy, immunotherapy, and radiation therapy. |
| Secondary | The duration of response (DOR) of the combination of abemaciclib and letrozole in the intention-to-treat (ITT) population at Week 24 and 3 years. | Week 24 and 3 years | The DOR is defined as the time from response until disease progression or death in patients who achieve complete or partial response. |
| Secondary | The clinical benefit rate (CBR) of the combination of abemaciclib and letrozole. | Week 24 and 3 years | The CBR is defined as the proportion of patients with a confirmed complete response (CR), partial response (PR) and stable disease (SD) maintained for at least 24 weeks. |
| Secondary | The incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0). | 3 years | Based on clinically relevant changes from baseline for vital signs and laboratory findings. CTCAE v5.0 uses a range of grades from 1 to 5: Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = life-threatening Grade 5 = death |
| Secondary | Progression-free survival (PFS). | 3 years | PFS is defined as the time from start of treatment until disease progression/relapse or death from any cause. If the specific event (disease progression/relapse, death, whatever comes first) does not occur, PFS will be censored at the date of last tumor assessment. In case no tumor assessment is available, patients will conservatively be censored at the date of first letrozole + abemaciclib dose. |
| Secondary | Overall survival (OS). | 3 years | OS is defined as the time from start of treatment until death from any cause. Patients who are still alive at the time of OS analysis will be censored at the last date they were known to be alive. |
| Secondary | Change from baseline in health-related quality of life using the EQ-5D-5L questionnaire. | Baseline and 3 years | The EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. |
| Secondary | Change from baseline in health-related quality of life using the EORTC QLQ-C30 questionnaire. | Baseline and 3 years | The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38453176 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05872204
GET https://conductscience.org/api/trials/v1/NCT05872204/registered