Clinical trial · Interventional
Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer
Neoadjuvant Tucidinostat and Exemestane in Estrogen Receptor-Positive Early Breast Cancer (NeoTEE)
NCT04465097CI-TRIAL-00070542NeoTEEcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients and explore the genetic model which can predict neoadjuvant endocrine therapeutic results.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exemestane | Drug | Exemestane | ALIAS |
| Ovarian function suppression | Drug | — | UNRESOLVED |
| Tucidinostat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tucidinostat and Exemestane
- description
- Patients receive exemestane from week 1 to week 26 and Tucidinostat BIW from week 3 to week 26. Courses continue in the absence of disease progression or unacceptable toxicity. If the patient is premenopausal, leuprorelin or goserelin will be prescribed.
- interventionNames
- Drug: Tucidinostat
- Drug: Exemestane
- Drug: Ovarian function suppression
Primary outcomes (1)
- measure
- objective response rate (ORR) evaluated by MRI
- timeFrame
- Up to 31 weeks
- description
- ORR is defined as percentage of participants with Complete Response and Partial Response, assessed by the investigators using MRI according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent must be signed; 2. Eastern Cooperative Oncology Group Performance Status: 0\~1; 3. Histological confirmation of estrogen receptor (ER) positive and HER 2 negative invasive breast cancer; 4. Age ≥18 years old; 5. No distant metastatic disease; 6. The disease condition is stage II or stage III; 7. Laboratory exam criteria for enrollment: HGB≥10g/dl, WBC≥4,000/mm3, PLT≥100,000/mm3, GOT, GPT, ALP≤2 times ULN, TBIL, CCr≤1.5 times ULN. Exclusion Criteria: 1. Patients who are pregnant or lactating at the time of randomization or refuse to contraception. 2. Patients who received organ transplantation (include bone marrow autologous transplantation and stem cell transplantation). 3. Patients who have other malignant diseases within 5 years, except for cured skin basal cell carcinoma, flat cell carcinoma or cervical carcinoma in situ 4. Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study. 5. Patients with sever hepatic, renal,cardiovascular, respiratory, digestive diseases or uncontrolled diabetes. 6. Patients who had myocardial infarction in the past 12 months. 7. Patients who participate in other clinical trail. 8. Patients who allergy to goserelin, leuprorelin, tucidinostat or aromatase inhibitor.
References
Publications (1)
- BACKGROUNDJiang Z, Li W, Hu X, Zhang Q, Sun T, Cui S, Wang S, Ouyang Q, Yin Y, Geng C, Tong Z, Cheng Y, Pan Y, Sun Y, Wang H, Ouyang T, Gu K, Feng J, Wang X, Wang S, Liu T, Gao J, Cristofanilli M, Ning Z, Lu X. Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):806-815. doi: 10.1016/S1470-2045(19)30164-0. Epub 2019 Apr 27. PMID 31036468