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Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
dose-dense nab-paclitaxel followed by EC
Sponsored by
Shantou Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Females with age of 18 to 70 years old. Newly diagnosed breast cancer patients. Planned neoadjuvant chemotherapy. Hormone receptor status: Estrogen receptor (ER)-positive or Progesterone Receptor (PR)- positive. HER2/neu-negative. Ki67≥30%. Clinical stage IIB-IIIC. Informed consent form understood and signed. Patient agrees to all follow-up visits. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. Women of childbearing potential must have a negative serum pregnancy test. Exclusion Criteria: Metastatic disease Pregnancy. Nursing mothers. Active or uncontrolled infection. Presence of another malignancies. Granulocyte count < 1.5*10^9/L. Platelet count < 100*10^9/L. Hemoglobin < 90g/L. Serum Creatinine more than 1.5 upper limit. AST and ALT more than 2.5 upper limit. LVEF< 50%.

Sites / Locations

  • Shantou Central HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dose-dense arm

Arm Description

Outcomes

Primary Outcome Measures

RCB
Residual Cancer Burden

Secondary Outcome Measures

Full Information

First Posted
February 4, 2023
Last Updated
February 4, 2023
Sponsor
Shantou Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05728268
Brief Title
Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
Official Title
Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shantou Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dose-dense arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
dose-dense nab-paclitaxel followed by EC
Intervention Description
dose-dense nab-paclitaxel followed by EC
Primary Outcome Measure Information:
Title
RCB
Description
Residual Cancer Burden
Time Frame
7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females with age of 18 to 70 years old. Newly diagnosed breast cancer patients. Planned neoadjuvant chemotherapy. Hormone receptor status: Estrogen receptor (ER)-positive or Progesterone Receptor (PR)- positive. HER2/neu-negative. Ki67≥30%. Clinical stage IIB-IIIC. Informed consent form understood and signed. Patient agrees to all follow-up visits. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. Women of childbearing potential must have a negative serum pregnancy test. Exclusion Criteria: Metastatic disease Pregnancy. Nursing mothers. Active or uncontrolled infection. Presence of another malignancies. Granulocyte count < 1.5*10^9/L. Platelet count < 100*10^9/L. Hemoglobin < 90g/L. Serum Creatinine more than 1.5 upper limit. AST and ALT more than 2.5 upper limit. LVEF< 50%.
Facility Information:
Facility Name
Shantou Central Hospital
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haitong Lyu
Phone
+8613631403739
Email
heton25@foxmali.com

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index

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