Chidamide in Combination With Abemaciclib and Fulvestrant in Breast Cancer Patients Previously Treated With Palbociclib

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the efficacy and safety of chidamide in combination with abemaciclib and fulvestrant in locally advanced/metastatic HR+/HER2- breast cancer who had failed prior Palbociclib therapy

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biyun Wang, MD
• Treatments: Fulvestrant

Criteria

Inclusion Criteria:

• Patients volunteered to participate in this study and signed an informed consent form.

• Female, aged ≥ 18 years.

• ECOG PS score:0-2.

• Expected survival time ≥ 3 months.

• Patients with locally advanced and/or metastatic breast cancer confirmed by histopathology with positive ER expression and negative HER2 expression.

• Previous anti-tumor regulations:

Unconsciously, she did not receive systemic chemotherapy for recurrent and metastatic breast cancer; Disease recurrence and metastasis occurred after treatment with pipexili-containing regimen in the assisted phase or disease progression occurred after treatment with pipexili-containing regimen for at least 6 months in the advanced phase; Regardless of whether a person has previously been treated with flurvestrine or has been treated without proving that the treatment has failed; Anyway, patients with relapsed and metastatic breast cancer receive at most three line endocrine therapy, which meets the following requirements: recurrence or metastasis occurs after more than 24 months of postoperative adjuvant endocrine therapy; Disease progression at least 6 months after the most recent endocrine therapy;

• At least one extracranial measurable lesion defined according to RECIST V1.1 criteria or only bone lesion;

• The functions of vital organs meet the requirements;

• Subjects recovered from any AE associated with prior tumor therapy prior to initial administration of the study drug (grade ≤1);

Exclusion Criteria:

• Prior treatment with histone deacetylase inhibitors (HDACi);

• Patients previously treated with cdK4/6 inhibitors other than pipercilil;

• Pia meningeal metastasis confirmed by MRI or lumbar puncture;

• Radiographically confirmed central nervous system metastasis; The following conditions were excluded: ① Asymptomatic brain metastases did not require immediate radiotherapy or surgery; ② Patients who had previously received treatment for cerebral or dural metastasis (radiotherapy or surgery) and had been stable for at least 4 weeks with imaging confirmation, and had stopped symptomatic treatment (including hormone, mannitol, bevacizumab, etc.) for more than 2 weeks without clinical symptoms could be included;

• Patients with visceral crises (e.g., lymphangitis carcinoma, bone marrow invasion, pia meningeal metastasis, diffuse liver metastasis with abnormal liver enzymes), rapid disease progression, and patients considered by researchers to be not suitable for endocrine therapy;

• Patients with ascites, pleural effusion and pericardial effusion with clinical symptoms at baseline, requiring drainage, or patients with serous cavity effusion drainage within 4 weeks before the first medication;

• Inability to swallow, intestinal obstruction or other factors affecting drug taking and absorption;

• Systematic treatment such as chemotherapy, molecular-targeted therapy or other investigational drugs within 4 weeks prior to the start of treatment; Received endocrine therapy within 2 weeks prior to starting treatment;

• The subject has had other malignancies within the past 5 years or at the same time (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and thyroid cancer);

• The patient has undergone major surgical procedures or significant trauma within 4 weeks prior to the start of treatment, or is expected to undergo major surgical treatment;

• Known history of allergy to the drug components of this regimen;

• Infected with active HBV and HCV; Patients with stabilized hepatitis B (DNA titer not higher than 500 IU/mL or copy number <1000 copies/ mL) and cured hepatitis C (negative for HCV RNA) were excluded;

• Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or have a history of organ transplantation;

• Positive baseline pregnancy test in pregnant or lactating women or fertile women; Or subjects of reproductive age who were unwilling to use effective contraception during study participation and for at least 3 months after the last dose;

• According to the judgment of the researcher, there are serious concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that endanger the patient's safety or affect the patient's completion of the study;

• The researcher determines that he is not suitable for the study;