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Trial Title:
Exploration of Dalpiciclib + Chidamide in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase Ⅰb Study
NCT ID:
NCT05586841
Condition:
HR+/HER2- Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Dalpiciclib
Chidamide
Maximum Tolerated Dose
the failure of CDK4/6 inhibitor therapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dalpiciclib
Description:
Dalpiciclib: 100 mg/d or 125 mg/d, po., qd, administered on an empty stomach (fasting
should be ensured at least 1 hour before and 1 hour after administration). The drug will
be administered in a 28-day cycle, with continuously administration in the first 3 weeks
(D1-21), and discontinuation in the fourth week (D22-28).
Arm group label:
Dalpiciclib + Chidamide
Other name:
SHR6390
Intervention type:
Drug
Intervention name:
Chidamide
Description:
Chidamide: 25 mg/BIW or 20 mg/BIW, po., q2w. The interval between doses should not be
less than 3 days (e.g. Monday and Thursday, Tuesday and Friday, Wednesday and Saturday,
etc.), administered 30 minutes after meals
Arm group label:
Dalpiciclib + Chidamide
Summary:
A phase 1B study to explore the maximum tolerated dose (MTD) of dalpiciclib + chidamide
in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects voluntarily participate in this study and sign the informed consent form
2. Female, aged ≥ 18 years.
3. ECOG PS score: 0-2 points.
4. Expected survival ≥ 3 months.
5. Regionally recurrent or metastatic disease with histologically or cytologically
confirmed ER+ and/or PR+ (≥ 10%), HER2- breast cancer that is not suitable for
definitive excision or radiation therapy.
6. Previously received antitumor therapy: 1) previously received ≤1 line of
chemotherapy for recurrent or metastatic breast cancer; 2) Disease recurrence and/or
metastasis during or after treatment with Palbociclib or Abemaciclib or Ribociclib
in the setting of (neo-)adjuvant therapy, or during treatment with palbociclib or
Abemaciclib or Ribociclib in a metastatic setting or after disease progression; 3)
No more than 3 lines of endocrine therapy have been previously received for
recurrent or metastatic breast cancer. 4) Line number of previous chemotherapy ≤1
line
7. At least one extracranial measurable lesion as defined by RECIST v1.1;
8. The function of vital organs meets the requirements;
- Absolute neutrophil count ≥ 1.5 × 10^9/L;
- Platelets ≥ 90 × 10^9/L;
- Hemoglobin ≥ 90g/L;
- Total bilirubin (TBIL) ≤ 1.5 × ULN;
- ALT and AST ≤ 2.5 × ULN;
- Urea/blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- The QT correction by the Fridericia formula (QTcF) is < 470 ms. INR ≤ 1.5 ×
ULN, APTT ≤ 1.5 × ULN.
9. Subject recovers from any AE related to previous antitumor therapy before the first
administration of the study drug (Grade ≤ 1).
Exclusion Criteria:
1. Previously received treatment with histone deacetylase inhibitor (HDACi);
2. Previously received Dalpiciclib;
3. MRI or lumbar puncture confirmed leptomeningeal metastasis;
4. Central nervous system metastasis is confirmed by imaging; The following conditions
will be excluded: 1) asymptomatic brain metastases without immediate radiotherapy or
surgery; 2) Previously received local treatment (radiotherapy or surgery) for brain
metastases, stable for at least 4 weeks, and no symptomatic treatment (including
glucocorticoids, mannitol, bevacizumab, etc.) for more than 2 weeks with clinical
symptoms;
5. The participants presented with visceral crisis (such as lymphangitis
carcinomatosis, bone marrow replacement, leptomeningeal metastasis, diffuse liver
metastasis with abnormal liver function), rapid disease progression, and that is not
suitable for endocrine therapy;
6. Participants had ascites, pleural effusion and pericardial effusion with clinical
symptoms at baseline, which required drainage within 4 weeks before the first
medication;
7. Inability to swallow, intestinal obstruction, or other factors that affect
medication administration and absorption;
8. Subjects that are diagnosed with any other malignancy within 5 years prior to the
study, excluding non-melanoma skin cancer treated with radical therapy, basal or
squamous cell skin cancer or carcinoma in situ of the cervix and papillary thyroid.
9. The subject has undergone major surgery or major trauma or is expected to undergo
major surgery within 4 weeks before the start of treatment;
10. A known history of allergy to the drug ingredient of this protocol;
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fifth Medical Center of PLA General Hospital
Address:
City:
Beijing
Zip:
100071
Country:
China
Start date:
November 1, 2022
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Beijing 302 Hospital
Agency class:
Other
Source:
Beijing 302 Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05586841
