Combining Tucidinostat and nab-paclitaxel for advanced HR+/HER2- breast cancer

A Phase II Study of Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer

This study is testing if combining Tucidinostat with nab-paclitaxel can help postmenopausal women with advanced HR+/HER2- breast cancer who haven't responded well to hormone therapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Hunan Cancer Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT05633914 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of Tucidinostat in combination with nab-paclitaxel for patients with advanced HR+/HER2- breast cancer. It targets postmenopausal women who have shown primary endocrine resistance or have previously undergone endocrine therapy. Participants must have measurable disease and meet specific organ function criteria. The study aims to provide a new treatment option for this patient population.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women aged 18 to 75 with advanced HR+/HER2- breast cancer who have experienced endocrine therapy resistance.

Not a fit: Patients with HER2 positive breast cancer or those who have had more than one line of chemotherapy for recurrent or metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced HR+/HER2- breast cancer.

How similar studies have performed: While this approach is being explored, similar combinations have shown promise in other studies, indicating potential for success.

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.

Where this trial is running

Changsha, Hunan

• Hunan Cancer Hospital — Changsha, Hunan, China (RECRUITING)

Study contacts

• Study coordinator: quchang ouyang, MD, PhD

Conditions: HR+/HER2- Breast Cancer