Breast CancerPhase 2NeoTEENCT04465097
Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer
A Phase 2 study testing Tucidinostat, Exemestane and Ovarian function suppression in people with Breast Cancer, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tucidinostat, Exemestane and Ovarian function suppression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2020to 1 Oct 2023
- 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
- Written informed consent must be signed；
- Eastern Cooperative Oncology Group Performance Status: 0~1;
- Histological confirmation of estrogen receptor (ER) positive and HER 2 negative invasive breast cancer;
- Age ≥18 years old；
- No distant metastatic disease；
- The disease condition is stage II or stage III;
- 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.
Who cannot join
- Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
- Patients who received organ transplantation (include bone marrow autologous transplantation and stem cell transplantation).
- Patients who have other malignant diseases within 5 years, except for cured skin basal cell carcinoma, flat cell carcinoma or cervical carcinoma in situ
- 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.
- Patients with sever hepatic, renal,cardiovascular, respiratory, digestive diseases or uncontrolled diabetes.
- Patients who had myocardial infarction in the past 12 months.
- Patients who participate in other clinical trail.
- Patients who allergy to goserelin, leuprorelin, tucidinostat or aromatase inhibitor.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Sun Yat-Sen university
Guangzhou, Guangdong, 510000
About this study
Official title: Neoadjuvant Tucidinostat and Exemestane in Estrogen Receptor-Positive Early Breast Cancer （NeoTEE）
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.
Read the detailed description
This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients.This study will recruit 30 patients. The 30 patients will receive 25 mg exemestane QD for 26 weeks. Tucidinostat will be prescribed 30 mg BIW from week 3 to week 26. During neoadjuvant treatment biopsy, CEUS and MRI will be perfomed according to protocol to evaluate the therapeutic results. Genetic testing will also be performed before and after neoadjuvant treatment to explore the predictive value. MRI evaluated ORR is primary end point. CEUS evaluated ORR, pCR, AE and RCB are secondary end point.
- Conditions
- Breast Cancer
- Being tested
- Tucidinostat, Exemestane, Ovarian function suppression
- Keywords
- Tucidinostat, Estrogen Receptor-Positive, Neoadjuvant endocrine therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucidinostatDrug
Also called Chidamide, Epidaza
Tucidinostat: 30 mg BIW (Monday and Thursday) from week 3 to week 26
ExemestaneDrug
Exemestane: 25 mg QD from week 1 to week 26.
Ovarian function suppressionDrug
If the patient is premenopausal, leuprorelin 3.75mg or goserelin 3.6 mg will be injected every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Tucidinostat and Exemestane | Experimental | 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. Receives: Drug: Tucidinostat; Drug: Exemestane; Drug: Ovarian function suppression |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR) evaluated by MRI
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)
Measured: Up to 31 weeks
Secondary outcomes (4)
objective response rate (ORR) evaluated by CEUS
Contrast-enhanced ultrasound will also be performed to assess ORR
Measured: Up to 31 weeks
pathologic complete response rate (pCR)
The percentage of participants with pathologically assessed ypT0 and ypTis of breast disease.
Measured: Up to 31 weeks
Adverse effect (AE)
All advese effect events related with Tucidinostat and Exemestane.
Measured: Up to 31 weeks
Residual Cancer Burden (RCB)
Pathologilly assessed residual cancer burden according to MD Anderson protocol.
Measured: Up to 31 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start8 Jul 2020
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Lin, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Ying Lin, MD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465097
- Sponsor's protocol ID
- 20200628GD
- Acronym
- NeoTEE
- Status last verified
- Oct 2023
- First submitted
- 30 Jun 2020
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang 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.
PubMed 31036468
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Tucidinostat and Exemestane in Estrogen Receptor-Positive Early Breast Cancer （NeoTEE）
- ClinicalTrials.gov ID
- NCT04465097
- Acronym / sponsor ID
- NeoTEE / 20200628GD
- Conditions
- Breast Cancer
- Keywords
- Tucidinostat, Estrogen Receptor-Positive, Neoadjuvant endocrine therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 9 Jul 2020 (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.
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.
Detailed description
This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients.This study will recruit 30 patients. The 30 patients will receive 25 mg exemestane QD for 26 weeks. Tucidinostat will be prescribed 30 mg BIW from week 3 to week 26. During neoadjuvant treatment biopsy, CEUS and MRI will be perfomed according to protocol to evaluate the therapeutic results. Genetic testing will also be performed before and after neoadjuvant treatment to explore the predictive value. MRI evaluated ORR is primary end point. CEUS evaluated ORR, pCR, AE and RCB are secondary end point.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucidinostat and Exemestane | Experimental | Drug: Tucidinostat, Drug: Exemestane, Drug: Ovarian function suppressionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent must be signed；
- Eastern Cooperative Oncology Group Performance Status: 0~1;
- Histological confirmation of estrogen receptor (ER) positive and HER 2 negative invasive breast cancer;
- Age ≥18 years old；
- No distant metastatic disease；
Key exclusion criteria (8 listed)
- Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
- Patients who received organ transplantation (include bone marrow autologous transplantation and stem cell transplantation).
- Patients who have other malignant diseases within 5 years, except for cured skin basal cell carcinoma, flat cell carcinoma or cervical carcinoma in situ
- 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.
- Patients with sever hepatic, renal,cardiovascular, respiratory, digestive diseases or uncontrolled diabetes.
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 |
|---|---|---|
| TucidinostatAlso: Chidamide, EpidazaTucidinostat: 30 mg BIW (Monday and Thursday) from week 3 to week 26 | Drug | Tucidinostat and Exemestane |
| ExemestaneExemestane: 25 mg QD from week 1 to week 26. | Drug | Tucidinostat and Exemestane |
| Ovarian function suppressionIf the patient is premenopausal, leuprorelin 3.75mg or goserelin 3.6 mg will be injected every 28 days. | Drug | Tucidinostat and Exemestane |
Primary outcome
objective response rate (ORR) evaluated by MRI
Time frame: Up to 31 weeks
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)
4 secondary outcomes
objective response rate (ORR) evaluated by CEUS
Time frame: Up to 31 weeks
pathologic complete response rate (pCR)
Time frame: Up to 31 weeks
Adverse effect (AE)
Time frame: Up to 31 weeks
Residual Cancer Burden (RCB)
Time frame: Up to 31 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 31036468Jiang 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.
- Individual participant dataSharing planned: No
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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.
Ying Lin, MD principal investigator
First Affiliated Hospital, Sun Yat-Sen 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 study testing Tucidinostat, Exemestane and Ovarian function suppression in people with Breast Cancer, run by First Affiliated Hospital, Sun Yat-Sen 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 7 inclusion and 8 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 17 Oct 2023. 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 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?
objective response rate (ORR) evaluated by MRI (time frame: Up to 31 weeks). 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 NCT04465097, 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 17 Oct 2023.