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

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05759572
Collaborator
(none)
145
Enrollment
1
Location
2
Arms
51.9
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Patients with SNF34subtype 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 Apatinib in SNF4 subtype of HR

+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
145 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Apatinib in Combination With CDK4/6 Inhibitor and Endocrine Therapy as the First-line Therapy for HR+/ HER2-Advanced Breast Cancer
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Jun 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

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

Drug: Apatinib
TKI

Drug: Dalpiciclib
CDK4/6 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

Outcome Measures

Primary Outcome Measures

  1. PFS [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)

Secondary Outcome Measures

  1. ORR [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)

  2. CBR [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.

  3. OS [Randomization to death from any cause, through the end of study (approximately 5 years)]

    time to death due to any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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-4 (SNF-4) 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

  • Page 3 of 4 [DRAFT] -

  • 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Breast cancer institute of Fudan University Cancer Hospital Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhimin Shao, Professor, Fudan University
ClinicalTrials.gov Identifier:
NCT05759572
Other Study ID Numbers:
  • SNF4
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhimin Shao, Professor, Fudan University
first-line therapy
Additional relevant MeSH terms:
Breast Neoplasms
Apatinib
Fulvestrant

Study Results

No Results Posted as of Mar 8, 2023