HR+/HER2- Breast CancerPhase 2NCT05633914
Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer
A Phase 2 study testing Tucidinostat and nab-paclitaxel in people with HR+/HER2- Breast Cancer, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
This study is looking to see whether the combination of Tucidinostat and nab-paclitaxel is safe and effective in participants with advanced HR+/HER2- breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HR+/HER2- Breast Cancer
- What is being tested?
- Tucidinostat and nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2023to 1 Dec 2025
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years, ≤75, female;
- Histologically confirmed HR positive and HER2 negative postmenopausal metastatic breast cancer patients [HER2 negative is defined as immunohistochemistry(IHC) 0 or IHC 1+, and if the score of IHC is 2+, fluorescence in situ hybridization technology (FISH) test must be negative, HR positve is defined as ER or PR ≥1%];
- Primary endocrine resistance or at least experienced one line of endocrine therapy for recurrent or metastatic disease;
- No more than 1 prior line of chemothrapy for recurrent or metastatic disease;
- Patients who have been exposed to taxanes in neoadjuvant or adjuvant setting will be allowed to enroll, if they have obtained benifits from neoadjuvant treatment or have progressed ≥ 12 months from completion of adjuvant treatment;
- ECOG performance status ≤ 1;
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- At least one measurable disease based on RECIST v1.1
- Adequate organ function;
- Life expectancy is more than 3 months;
- Willing and able to provide written informed consent.
Who cannot join
- Prior exposed to histone deacetylase inhibitors, or received taxanes for metastatic disease;
- Known hypersensitivity to any formulation component of the study drug;
- Received chemotherapy, targeted therapy, Chinese herbal medicine with anti-tumor indications, or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 4 weeks before enrollment, or still within 5 half-lives of such drugs;
- Toxicities that did not recover to National Cancer Institute Common Adverse Event Terminology Version 5.0 (NCICTCAEv5.0) grade 0 or 1 toxicity from prior antineoplastic therapy prior to the first dose of study treatment(alopecia, grade 2 fatigue, grade 2 anemia, non-clinically critical and asymptomatic laboratory abnormalities can be enrolled);
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Pregnant or lactating female.
- Any other conditions deemed inappropriate by the investigator to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
quchang ouyang, 0731-89762160, oyqc1969@126.com
About this study
Official title: A Phase II Study of Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer
This study is looking to see whether the combination of Tucidinostat and nab-paclitaxel is safe and effective in participants with advanced HR+/HER2- breast cancer.
- Conditions
- HR+/HER2- Breast Cancer
- Being tested
- Tucidinostat, nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucidinostatDrug
Also called Chidamide
20mg, po., biw, q3w
nab-paclitaxelDrug
Also called ABRAXANE
125mg/m2, d1, iv.drip, q7d
| Study group | Role | What they receive |
|---|---|---|
| Tucidinostat and nab-paclitaxel | Experimental | Not described Receives: Drug: Tucidinostat; Drug: nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
ORR by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
Measured: 2 years
Secondary outcomes (3)
Progression-free survival(PFS)
Time from treatment until disease progression or death
Measured: 2 years
Disease Control Rate （DCR）
the total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD）
Measured: 2 years
Disease Control Rate （DCR）
Time from treatment until death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start7 Feb 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Breast CancerStudies of the same condition, open and under way.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633914
- Sponsor's protocol ID
- CSIIT-C34
- Status last verified
- Feb 2023
- First submitted
- 21 Nov 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer
- ClinicalTrials.gov ID
- NCT05633914
- Acronym / sponsor ID
- CSIIT-C34
- Conditions
- HR+/HER2- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 1 Dec 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 study is looking to see whether the combination of Tucidinostat and nab-paclitaxel is safe and effective in participants with advanced HR+/HER2- breast cancer.
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 nab-paclitaxel | Experimental | Drug: Tucidinostat, Drug: nab-paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age≥18 years, ≤75, female;
- Histologically confirmed HR positive and HER2 negative postmenopausal metastatic breast cancer patients [HER2 negative is defined as immunohistochemistry(IHC) 0 or IHC 1+, and if the score of IHC is 2+, fluorescence in situ hybridization technology (FISH) test must be negative, HR positve is defined as ER or PR ≥1%];
- Primary endocrine resistance or at least experienced one line of endocrine therapy for recurrent or metastatic disease;
- No more than 1 prior line of chemothrapy for recurrent or metastatic disease;
- Patients who have been exposed to taxanes in neoadjuvant or adjuvant setting will be allowed to enroll, if they have obtained benifits from neoadjuvant treatment or have progressed ≥ 12 months from completion of adjuvant treatment;
Key exclusion criteria (7 listed)
- Prior exposed to histone deacetylase inhibitors, or received taxanes for metastatic disease;
- Known hypersensitivity to any formulation component of the study drug;
- Received chemotherapy, targeted therapy, Chinese herbal medicine with anti-tumor indications, or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 4 weeks before enrollment, or still within 5 half-lives of such drugs;
- Toxicities that did not recover to National Cancer Institute Common Adverse Event Terminology Version 5.0 (NCICTCAEv5.0) grade 0 or 1 toxicity from prior antineoplastic therapy prior to the first dose of study treatment(alopecia, grade 2 fatigue, grade 2 anemia, non-clinically critical and asymptomatic laboratory abnormalities can be enrolled);
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
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: Chidamide20mg, po., biw, q3w | Drug | Tucidinostat and nab-paclitaxel |
| nab-paclitaxelAlso: ABRAXANE125mg/m2, d1, iv.drip, q7d | Drug | Tucidinostat and nab-paclitaxel |
Primary outcome
Objective Response Rate（ORR）
Time frame: 2 years
ORR by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
3 secondary outcomes
Progression-free survival(PFS)
Time frame: 2 years
Disease Control Rate （DCR）
Time frame: 2 years
Disease Control Rate （DCR）
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- 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.
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 and nab-paclitaxel in people with HR+/HER2- Breast Cancer, run by Hunan Cancer Hospital 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 10 inclusion and 7 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 21 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact quchang ouyang, MD, PhD (0731-89762160, oyqc1969@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate（ORR） (time frame: 2 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 21 Feb 2023.