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

February 4, 2024 updated by: Zhimin Shao, Fudan University

PARP Inhibitor in Combination With CDK4/6 Inhibitor and Endocrine Therapy as the First-line Therapy for HR+/ HER2-Advanced Breast Cancer

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Breast cancer institute of Fudan University Cancer Hospital
        • Sub-Investigator:
          • Ying Zhou
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhi-Ming Shao, MD
        • Sub-Investigator:
          • Lei Fan, MD
        • Sub-Investigator:
          • Wenjuan Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with Fluzoparib(Parp inhibitor) and endocrine therapy.
Drug: Dalpiciclib
CDK4/6 inhibitor
Drug: Fluzoparib
Parp inhibitor
Drug: Fulvestrant/AI
Endocrine therapy
Active Comparator: Cohort 2
In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with endocrine therapy.
Drug: Dalpiciclib
CDK4/6 inhibitor
Drug: Fulvestrant/AI
Endocrine therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
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)
time to progressive disease (according to RECIST1.1)
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 Measures

Outcome Measure
Measure Description
Time Frame
ORR
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)
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
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)
OS
Time Frame: Randomization to death from any cause, through the end of study (approximately 5 years)
time to death due to any cause
Randomization to death from any cause, through the end of study (approximately 5 years)
CBR
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)
the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Chongqing University Cancer Hospital
Sun Yat-sen University
Peking University Cancer Hospital & Institute
First Affiliated Hospital Xi'an Jiaotong University
Ningbo Medical Center Lihuili Hospital
Fujian Medical University Union Hospital
First Hospital of China Medical University
Shanghai First Maternity and Infant Hospital
Liaoning Tumor Hospital & Institute
Shanghai 6th People's Hospital
Affiliated Hospital of Nantong University
Northern Jiangsu People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 26, 2023

First Submitted That Met QC Criteria

February 26, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCTOP-L-M03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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