Clinical trial NCT05633914: Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer
Official title: A Phase II Study of Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HR+/HER2- Breast Cancer
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age≥18 years, ≤75, female;
2. Histologically confirmed HR positive and HER2 negative postmenopausal metastatic breast cancer patients \[HER2 negative is defined as immunohistochemistry(IHC) 0 or IHC 1+, and if the score of IHC is 2+, fluorescence in situ hybridization technology (FISH) test must be negative, HR positve is defined as ER or PR ≥1%\];
3. Primary endocrine resistance or at least experienced one line of endocrine therapy for recurrent or metastatic disease;
4. No more than 1 prior line of chemothrapy for recurrent or metastatic disease;
5. 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;
6. ECOG performance status ≤ 1;
7. At least one measurable disease based on RECIST v1.1
8. Adequate organ function;
9. Life expectancy is more than 3 months;
10. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Prior exposed to histone deacetylase inhibitors, or received taxanes for metastatic disease;
2. Known hypersensitivity to any formulation component of the study drug;
3. 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;
4. 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);
5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
6. Pregnant or lactating female.
7. Any other conditions deemed inappropriate by the investigator to participate in this study.

Primary outcomes:
measure: Objective Response Rate（ORR）
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 2 years
measure: Disease Control Rate （DCR）
timeFrame: 2 years
measure: Disease Control Rate （DCR）
timeFrame: 2 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
References: