Overview

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;