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Fluzoparib in Combination With Chidamide or Camrelizumab for HRD Positive HER2 Negative Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05085626
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:
This study is planned to include 40 patients with HER2-negative advanced breast cancer to receive fluzoparib combined with chidamide or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of fluzoparib combined with camrelizumab or chidamide in the treatment of HRD-positive HER2-negative advanced breast cancer.

Condition or disease Intervention/treatment Phase
Advanced HER2 Negative Breast Carcinoma HRD+Breast Cancer Drug: fluzoparib+chidamide Drug: fluzoparib+camrelizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Single-center, Cohort Clinical Study of Fluzoparib in Combination With Chidamide or Camrelizumab for HRD Positive and HER2-negative Advanced Breast Cancer
Actual Study Start Date : February 8, 2021
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: fluzoparib+chidamide

Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance.

Chidamide: It is recommended to take 20 mg (4 tablets) twice a week, with an interval of no less than 3 days between doses (such as Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), for 30 minutes. Until disease progression or intolerable to patient.

Drug: fluzoparib+chidamide
Arms A will be treated with fluzoparib in combination with cedaramide

Experimental: fluzoparib+camrelizumab

Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance.

Camrelizumab: 200 mg IV drip over approximately 30 minutes (no less than 20 minutes and no more than 60 minutes) on Day 1 of each 3-week treatment cycle until disease progression or intolerance.

Drug: fluzoparib+camrelizumab
Arms B will be treated with fluzoparib in combination with camrelizumab




Primary Outcome Measures :
  1. ORR(objective response rate) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    through study completion, an average of 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. histologically confirmed initial stage IV breast cancer or recurrent metastatic breast cancer; advanced treatment stage received at least 1 line of chemotherapy but no more than 2 lines of chemotherapy; hormone receptor-positive patients received at least one endocrine therapy in advanced treatment stage, or the investigator judged that they were not suitable for endocrine therapy; and patients with hormone receptor-positive advanced breast cancer who progressed within 2 years of adjuvant endocrine therapy.
  2. histologically confirmed invasive HER2-negative breast cancer (specific definition: HER20-1 + or HER2 2 + by immunohistochemistry but negative or no amplification by FISH or CISH, following the 2018 version of the ASCO-CAPHER2 guidelines for negative interpretation);
  3. central confirmation of HRD positivity, known germline BRCA and/or systemic BRCA mutation status is allowed to be preferred.
  4. age 18-70 years
  5. According to RECIST 1.1, at least one measurable lesion is present;
  6. ECOG score: 0-2; expected survival more than 12 weeks;
  7. Previous treatment with immune checkpoint inhibitors, PARP inhibitors and HDAC inhibitors (including chidamine, romidepsin, vorinostat, benirestat, parastat, etc.);
  8. All acute toxicities caused by previous anti-tumor treatment return to the level specified in the inclusion/exclusion criteria (except alopecia and other toxicities that are considered by the investigator to pose no safety risk to the subjects);
  9. Female subjects of childbearing potential need to use a medically recognized contraceptive measure during the study treatment and at least 3 months after the last use of the study drug;
  10. Patients with known hormone receptor status;
  11. Main organ function is basically normal, and meet the following conditions:

    1. Blood routine examination criteria need to meet: HB ≥ 90 g/L (14 without blood transfusion); ANC ≥ 1.5 × 109/L; PLT ≥ 75 × 109/L;
    2. Biochemical examination need to meet the following criteria: TBIL ≤ 1.5 × ULN (upper limit of normal); ALT and AST ≤ 3 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN; serum Cr ≤ 1 × ULN;
    3. cardiac function: LVEF ≥ 50%
  12. The subject voluntarily joined the study and signed the informed consent form.

Exclusion Criteria:

  1. Uncontrolled central nervous system metastasis (defined as symptoms or requiring glucocorticoids or mannitol to control symptoms);
  2. Clinically symptomatic third space effusion, pericardial effusion, pleural effusion and abdominal effusion that cannot be controlled by pumping or other treatments;
  3. Currently or recently (within 30 days before enrollment) is participating in another clinical study;
  4. Five Other malignant tumors (except adequately treated cervical carcinoma in situ or skin squamous cell carcinoma or controlled skin basal cell carcinoma) within the past 4 years;
  5. Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA grade 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc > 470 ms;
  6. Hyperactive/venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
  7. He following history 24 days before signing the ICF: gastrointestinal ulcers, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease or inflammation, abdominal fistula, tracheoesophageal fistula or intra-abdominal abscess;
  8. Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction;
  9. Patients with a clear history of allergy, Potential allergy or intolerance to cidaniline, fluzoparib, and carreizumab;
  10. Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method);
  11. Female patients during pregnancy and lactation, female patients of childbearing potential with positive baseline pregnancy test or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
  12. According to the investigator's judgment, the presence of concomitant diseases (including but not limited to hypertension with poor drug control, severe diabetes, neurological or psychiatric diseases, active infection, etc.) or any other condition that seriously endangers the subject's safety, may confound the study results, or affect the subject's completion of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085626


Contacts
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Contact: Chunfang Hao 18622223686 haochf@163.com
Contact: SILU WANG 18559171530 wangsiluaaron@163.com

Locations
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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China
Contact: Chunfang Hao    18622223686    haochf@163.com   
Contact: Silu Wang    18559171530    wangsiluaaron@163.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT05085626    
Other Study ID Numbers: BC-Fluzoparib
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases