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Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC

Primary Purpose

Triple Negative Breast Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide

paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

Female, aged ≥ 18 yrs and ≤70 yrs；
Histological confirmation of Unilateral primary invasive breast cancer, cT2-4NanyM0, planning to receive neoadjuvant chemotherapy；
The expression of ER<10%，PR <10% and Her-2 negative by immunohistochemical, if HER2 expression ++, further FISH test confirmed no amplification of Her-2 gene；
ECOG performance status 0-1；
LVEF≥55%；
Bone marrow function: neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L；
Liver and renal function：Serum creatinine ≤ 1.5x ULN；Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN；Total bilirubin ≤ 1.5x ULN or when patients with Gilbert's syndrome ≤ 2.5x ULN；
The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form.

Exclusion Criteria:

Cytotoxic chemotherapy, endocrine therapy or radiation therapy for any reason；
New York Heart Association (NYHA) score identifies patients with heart disease above grade II (including grade II)；
Patients with severe systemic infections or other serious illnesses；
Patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients；
Combined with other malignant tumors or had malignant tumors other than breast cancer in the past 5 years, except for cervical carcinoma in situ and non-melanoma skin cancer that have been fully treated；
Women of childbearing age who are pregnant or lactating and who refuse to take appropriate contraceptive measures during the trial；
Participated in other experimental studies within 30 days before the first dose of study drug administration
Researchers judged patients who were unsuitable for this study.

Sites / Locations

Fourth Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nab-paclitaxel Based Regimens

Paclitaxel Based Regimens

Arm Description

Outcomes

Primary Outcome Measures

pathologic complete response（pCR）

pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0)

Secondary Outcome Measures

Objective Response Rate (ORR)

Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

Disease-free survival（DFS）

Disease-free survival refers to the time from surgical resection of breast cancer to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death.

Overall survival（OS）

Overall survival is defined as the length of time from random assignment to death or to last contact.

adverse events（AEs）

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.

Full Information

NCT ID

NCT04067102

First Posted

August 14, 2019

Last Updated

July 6, 2021

Sponsor

Hebei Medical University Fourth Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04067102

Brief Title

Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC

Official Title

Albumin Bound (Nab)-Paclitaxel Combined With Carboplatin Versus Paclitaxel Combined With Carboplatin Followed by Epirubicin and Cyclophosphamide as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Withdrawn

Why Stopped

No patients recruited

Study Start Date

May 10, 2019 (Actual)

Primary Completion Date

May 2021 (Anticipated)

Study Completion Date

May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hebei Medical University Fourth Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To evaluate the efficacy and safety of P nab-paclitaxel combined with carboplatin versus paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide in the neoadjuvant treatment of triple negative breast cancer.

6. Conditions and Keywords

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

Triple Negative Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nab-paclitaxel Based Regimens

Arm Type

Experimental

Arm Title

Paclitaxel Based Regimens

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide

Intervention Description

Paclitaxel for injection (albumin binding)260mg/m2，I.v., d1；carboplatin AUC=5, I.v., d1； 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle，and use the EC protocol in advance or decide the next treatment

Intervention Type

Drug

Intervention Name(s)

paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide

Intervention Description

Paclitaxel 175mg/m2, I.v., d1； Carboplatin injection AUC 5, I.v., d1； 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle，and use the EC protocol in advance or decide the next treatment protocol by the researcher

Primary Outcome Measure Information:

Title

pathologic complete response（pCR）

Description

pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

Time Frame

3 months

Title

Disease-free survival（DFS）

Description

Disease-free survival refers to the time from surgical resection of breast cancer to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death.

Time Frame

5 years

Title

Overall survival（OS）

Description

Overall survival is defined as the length of time from random assignment to death or to last contact.

Time Frame

5 years

Title

adverse events（AEs）

Description

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.

Time Frame

until 28 days after the last study drug administration

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female, aged ≥ 18 yrs and ≤70 yrs； Histological confirmation of Unilateral primary invasive breast cancer, cT2-4NanyM0, planning to receive neoadjuvant chemotherapy； The expression of ER<10%，PR <10% and Her-2 negative by immunohistochemical, if HER2 expression ++, further FISH test confirmed no amplification of Her-2 gene； ECOG performance status 0-1； LVEF≥55%； Bone marrow function: neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L； Liver and renal function：Serum creatinine ≤ 1.5x ULN；Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN；Total bilirubin ≤ 1.5x ULN or when patients with Gilbert's syndrome ≤ 2.5x ULN； The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form. Exclusion Criteria: Cytotoxic chemotherapy, endocrine therapy or radiation therapy for any reason； New York Heart Association (NYHA) score identifies patients with heart disease above grade II (including grade II)； Patients with severe systemic infections or other serious illnesses； Patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients； Combined with other malignant tumors or had malignant tumors other than breast cancer in the past 5 years, except for cervical carcinoma in situ and non-melanoma skin cancer that have been fully treated； Women of childbearing age who are pregnant or lactating and who refuse to take appropriate contraceptive measures during the trial； Participated in other experimental studies within 30 days before the first dose of study drug administration Researchers judged patients who were unsuitable for this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yunjiang Liu, MD

Organizational Affiliation

Hebei Medical University Fourth Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fourth Hospital of Hebei Medical University

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050011

Country

China

12. IPD Sharing Statement

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Nab-paclitaxel Based Regimens VS Paclitaxel Based Regimens in Neoadjuvant Treatment for TNBC

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