Breast NeoplasmsPhase 2/3NCT05253066
Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
A Phase 2/3 study testing Chidamide combined with exemestane (+/- goserelin) and Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician) in people with Breast Neoplasms, run by Shengjing Hospital.
Trial summary
This is an open, multicenter, randomized controlled clinical study aimed to explore the efficacy and safety of chidamide combined with exemestane (+/- goserelin) versus chemotherapy in the neoadjuvant treatment of stage II-III HR +/HER2- breast cancer patients with poor response to previous chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Chidamide combined with exemestane (+/- goserelin) and Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2022to 31 Jan 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients aged greater than or equal to 18 years and less than or equal to 75 years, meet one of the following:
- previous oophorectomy, or age ≥ 60 years;
- age < 60 years, natural postmenopausal status (defined as at least 12 consecutive months of spontaneous cessation of regular menstruation, and no other pathological or physiological causes), E2 and FSH in postmenopausal levels;
- premenopausal or perimenopausal female patients, must be willing to receive LHRH agonist therapy during the study;
- all patients were confirmed by histopathology as estrogen receptor (ER) positive (> 10%), HER2 receptor negative.Follow the 2018 version of ASCO-CAP HER2-negative interpretation guideline criteria;
- tumor stage II-III meeting the AJCC 8th version criteria, patients who have previously received 2 cycles of TE regimen chemotherapy, with disease evaluation of SD or PD;
Show all 12Show fewer
- KPS score ≥ 70 points;
- organ function level must meet the following requirements:
- bone marrow function ANC ≥ 1.5 × 109/L (14 without growth factors); PLT ≥ 100 × 109/L (7 without corrective treatment); Hb ≥ 100 g/L (7) without corrective treatment;
- liver and kidney function TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);
- able to undergo needle biopsy;
- voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up
Who cannot join
- received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- received any other anti-tumor therapy at the same time;
- breast cancer, inflammatory breast cancer or occult breast cancer;
- stage IV breast cancer;
- breast cancer without histopathological diagnosis;
About this study
Official title: An Open, Multicenter, Randomized Controlled Clinical Study of Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
This is an open, multicenter, randomized controlled clinical study aimed to explore the efficacy and safety of chidamide combined with exemestane (+/- goserelin) versus chemotherapy in the neoadjuvant treatment of stage II-III HR +/HER2- breast cancer patients with poor response to previous chemotherapy.
- Conditions
- Breast Neoplasms
- Being tested
- Chidamide combined with exemestane (+/- goserelin), Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide combined with exemestane (+/- goserelin)Drug
Chidamide combined with exemestane (+/- goserelin)
Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)Drug
Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)
| Study group | Role | What they receive |
|---|---|---|
| Chidamide group | Experimental | Chidamide combined with exemestane (+/- goserelin) Receives: Drug: Chidamide combined with exemestane (+/- goserelin) |
| chemotherapy group | Active comparator | Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician) Receives: Drug: Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Measured: Up to approximately 48 months
Secondary outcomes (8)
pCR：Upon completion of neoadjuvant therapy and surgery, there was no residual invasive carcinoma present in the pathologic assessment of the resected breast cancer samples stained with hematoxylin and eosin and all ipsilateral lymph node samples.
Measured: Up to approximately 48 months
Residual tumor burden (RCB) classification
Measured: Up to approximately 48 months
Total breast pathological complete remission rate (bpCR)
Measured: Up to approximately 48 months
PEPI classification
Measured: Up to approximately 48 months
Breast-conserving rate
Measured: Up to approximately 48 months
patient-reported outcome（PRO）：evaluate daily functioning and health outcomes from the patient's perspective by HRQOL
Measured: Up to approximately 48 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Up to approximately 48 months
Number of participants with treatment-related serious adverse event as assessed by CTCAE v5.0
Measured: Up to approximately 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start25 Feb 2022 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caigang Liu, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253066
- Sponsor's protocol ID
- MUKDEN5
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2022
- Last updated
- 23 Feb 2022
- 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 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter, Randomized Controlled Clinical Study of Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05253066
- Acronym / sponsor ID
- MUKDEN5
- Conditions
- Breast Neoplasms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 25 Feb 2022 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 23 Feb 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.
This is an open, multicenter, randomized controlled clinical study aimed to explore the efficacy and safety of chidamide combined with exemestane (+/- goserelin) versus chemotherapy in the neoadjuvant treatment of stage II-III HR +/HER2- breast cancer patients with poor response to previous chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chidamide group | Experimental | Drug: Chidamide combined with exemestane (+/- goserelin)Chidamide combined with exemestane (+/- goserelin) |
| chemotherapy group | Active comparator | Drug: Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- female patients aged greater than or equal to 18 years and less than or equal to 75 years, meet one of the following:
- all patients were confirmed by histopathology as estrogen receptor (ER) positive (> 10%), HER2 receptor negative.Follow the 2018 version of ASCO-CAP HER2-negative interpretation guideline criteria;
- tumor stage II-III meeting the AJCC 8th version criteria, patients who have previously received 2 cycles of TE regimen chemotherapy, with disease evaluation of SD or PD;
- KPS score ≥ 70 points;
- organ function level must meet the following requirements:
Key exclusion criteria (5 listed)
- received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- received any other anti-tumor therapy at the same time;
- breast cancer, inflammatory breast cancer or occult breast cancer;
- stage IV breast cancer;
- breast cancer without histopathological diagnosis;
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 |
|---|---|---|
| Chidamide combined with exemestane (+/- goserelin)Chidamide combined with exemestane (+/- goserelin) | Drug | Chidamide group |
| Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician) | Drug | chemotherapy group |
Primary outcome
ORR
Time frame: Up to approximately 48 months
8 secondary outcomes
pCR：Upon completion of neoadjuvant therapy and surgery, there was no residual invasive carcinoma present in the pathologic assessment of the resected breast cancer samples stained with hematoxylin and eosin and all ipsilateral lymph node samples.
Time frame: Up to approximately 48 months
Residual tumor burden (RCB) classification
Time frame: Up to approximately 48 months
Total breast pathological complete remission rate (bpCR)
Time frame: Up to approximately 48 months
PEPI classification
Time frame: Up to approximately 48 months
Breast-conserving rate
Time frame: Up to approximately 48 months
patient-reported outcome（PRO）：evaluate daily functioning and health outcomes from the patient's perspective by HRQOL
Time frame: Up to approximately 48 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to approximately 48 months
Number of participants with treatment-related serious adverse event as assessed by CTCAE v5.0
Time frame: Up to approximately 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Chidamide combined with exemestane (+/- goserelin) and Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician) in people with Breast Neoplasms, run by Shengjing Hospital.
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 12 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
ORR (time frame: Up to approximately 48 months). 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 23 Feb 2022.