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PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer

Primary Purpose

Breast Cancer Metastatic

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fluzoparib
Dalpiciclib
Fulvestrant/AI
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Metastatic focused on measuring first-line therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Females ≥18 years and ≤ 75 years old; Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER> 10% tumor cell positive is defined as ER positive, PR> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative); Subtype of similarity network fusion-3 (SNF-3) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital • Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer; Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions; Has adequate bone marrow function: absolute neutrophil count > 1.5x10ˆ9 /L; platelet count > 75x10ˆ9 /L, hemoglobin > 9g/dL; Patients had received no previous chemotherapy or targeted therapy for metastatic disease Has adequate liver function and kidney function: serum creatinine ECOG score ≤ 2 and life expectancy ≥ 3 months; Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. Exclusion Criteria: Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms); Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months); is pregnant or breast feeding; Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).

Sites / Locations

  • Breast cancer institute of Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cohort 1

Cohort 2

Arm Description

In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with Fluzoparib(Parp inhibitor) and endocrine therapy.

In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with endocrine therapy.

Outcomes

Primary Outcome Measures

PFS
time to progressive disease (according to RECIST1.1)

Secondary Outcome Measures

ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
CBR
the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
OS
time to death due to any cause

Full Information

First Posted
February 26, 2023
Last Updated
May 7, 2023
Sponsor
Fudan University
Collaborators
Peking University Cancer Hospital & Institute, First Hospital of China Medical University, Sun Yat-sen University, First Affiliated Hospital Xi'an Jiaotong University, Liaoning Tumor Hospital & Institute, Chongqing University Cancer Hospital, Northern Jiangsu Province People's Hospital, Fujian Medical University Union Hospital, Ningbo Medical Center Lihuili Hospital, Shanghai First Maternity and Infant Hospital, Shanghai 6th People's Hospital, Affiliated Hospital of Nantong University
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1. Study Identification

Unique Protocol Identification Number
NCT05759546
Brief Title
PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
Official Title
PARP Inhibitor in Combination With CDK4/6 Inhibitor and Endocrine Therapy as the First-line Therapy for HR+/ HER2-Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
June 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Peking University Cancer Hospital & Institute, First Hospital of China Medical University, Sun Yat-sen University, First Affiliated Hospital Xi'an Jiaotong University, Liaoning Tumor Hospital & Institute, Chongqing University Cancer Hospital, Northern Jiangsu Province People's Hospital, Fujian Medical University Union Hospital, Ningbo Medical Center Lihuili Hospital, Shanghai First Maternity and Infant Hospital, Shanghai 6th People's Hospital, Affiliated Hospital of Nantong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Detailed Description
Patients with SNF3 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. The main purpose is to evaluate efficacy of PARP inhibitor in SNF3 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Metastatic
Keywords
first-line therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with Fluzoparib(Parp inhibitor) and endocrine therapy.
Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Description
In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with endocrine therapy.
Intervention Type
Drug
Intervention Name(s)
Fluzoparib
Intervention Description
Parp inhibitor
Intervention Type
Drug
Intervention Name(s)
Dalpiciclib
Intervention Description
CDK4/6 inhibitor
Intervention Type
Drug
Intervention Name(s)
Fulvestrant/AI
Intervention Description
Endocrine therapy
Primary Outcome Measure Information:
Title
PFS
Description
time to progressive disease (according to RECIST1.1)
Time Frame
Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
Secondary Outcome Measure Information:
Title
ORR
Description
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time Frame
Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
Title
CBR
Description
the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
Time Frame
: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
Title
OS
Description
time to death due to any cause
Time Frame
Randomization to death from any cause, through the end of study (approximately 5 years)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females ≥18 years and ≤ 75 years old; Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER> 10% tumor cell positive is defined as ER positive, PR> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative); Subtype of similarity network fusion-3 (SNF-3) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital • Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer; Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions; Has adequate bone marrow function: absolute neutrophil count > 1.5x10ˆ9 /L; platelet count > 75x10ˆ9 /L, hemoglobin > 9g/dL; Patients had received no previous chemotherapy or targeted therapy for metastatic disease Has adequate liver function and kidney function: serum creatinine ECOG score ≤ 2 and life expectancy ≥ 3 months; Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. Exclusion Criteria: Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms); Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months); is pregnant or breast feeding; Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhimin Shao
Phone
86-021-64175590
Ext
8888
Email
zhimingshao@yahoo.com
Facility Information:
Facility Name
Breast cancer institute of Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Ming Shao, MD
Phone
86-21-641755901105
Email
zhimingshao@yahoo.com
First Name & Middle Initial & Last Name & Degree
Lei Fan, MD
Phone
86-21-641755901105
Email
cmchen@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Zhi-Ming Shao, MD
First Name & Middle Initial & Last Name & Degree
Lei Fan, MD
First Name & Middle Initial & Last Name & Degree
Wenjuan Zhang, MD
First Name & Middle Initial & Last Name & Degree
Ying Zhou

12. IPD Sharing Statement

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PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer

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