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Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer

Primary Purpose

Breast Cancer, Triple-negative Breast Cancer, Nab-paclitaxel

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nab-paclitaxel + Carboplatin

Nab-paclitaxel + Epirubicin

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Triple-negative Breast Cancer, Nab-paclitaxel, Carboplatin, Epirubicin

Eligibility Criteria

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

Inclusion Criteria:

Females with age between 18 to 70 years old;
Histologically confirmed primary invasive breast cancer;
Histologically confirmed triple negative breast cancer;
Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.
Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.
Have at least one measurable lesion as per the RECIST criteria (version 1.1);
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
LVEF≥55%；
Bone marrow function：neutrophils (≥1.5×10^9/L), platelets (≥100×10^9/L), hemoglobin (≥90 g/L);
Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;
Patients had good compliance with the planned treatment, understood the research process and written informed consent.

Exclusion Criteria:

Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;
Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
Patients with severe systemic infection or other serious diseases;
Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
The researchers considered the patients who were not suitable for enrollment.

Sites / Locations

The Fourth Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nab-paclitaxel + Carboplatin

Nab-paclitaxel + Epirubicin

Arm Description

nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles；

nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and epirubicin given IV at 75 mg/m^2 on days 1 every 21 days x 6 cycles；

Outcomes

Primary Outcome Measures

pCR (pathological complete response)

No residual infiltrating cancer cells were found in surgical specimens of breast and axillary lymph nodes; residual cancer cells in situ in surgical specimens can also be considered to achieve pCR

Secondary Outcome Measures

Objective response rate (ORR)

Disease free survival（DFS）

Adverse events (AE)

Full Information

NCT ID

NCT04138719

First Posted

October 23, 2019

Last Updated

November 7, 2019

Sponsor

Hebei Medical University Fourth Hospital

Collaborators

Beijing 302 Hospital, CSPC Ouyi Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04138719

Brief Title

Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer

Official Title

Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 20, 2019 (Anticipated)

Primary Completion Date

October 20, 2020 (Anticipated)

Study Completion Date

June 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hebei Medical University Fourth Hospital

Collaborators

Beijing 302 Hospital, CSPC Ouyi Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a multicenter, open, randomized, comparison study. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. Neoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. The purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery. The purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application. The total number of patients to be included in this study is 520 patients.

6. Conditions and Keywords

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

Breast Cancer, Triple-negative Breast Cancer, Nab-paclitaxel

Keywords

Triple-negative Breast Cancer, Nab-paclitaxel, Carboplatin, Epirubicin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nab-paclitaxel + Carboplatin

Arm Type

Experimental

Arm Description

nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles；

Arm Title

Nab-paclitaxel + Epirubicin

Arm Type

Active Comparator

Arm Description

nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and epirubicin given IV at 75 mg/m^2 on days 1 every 21 days x 6 cycles；

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel + Carboplatin

Intervention Description

nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles;

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel + Epirubicin

Intervention Description

nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and epirubicin given IV at 75 mg/m^2 on days 1 every 21 days x 6 cycles；

Primary Outcome Measure Information:

Title

pCR (pathological complete response)

Description

No residual infiltrating cancer cells were found in surgical specimens of breast and axillary lymph nodes; residual cancer cells in situ in surgical specimens can also be considered to achieve pCR

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Objective response rate (ORR)

Time Frame

3 years

Title

Disease free survival（DFS）

Time Frame

3 years

Title

Adverse events (AE)

Time Frame

3 years

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Females with age between 18 to 70 years old; Histologically confirmed primary invasive breast cancer; Histologically confirmed triple negative breast cancer; Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm. Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained. Have at least one measurable lesion as per the RECIST criteria (version 1.1); Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one; LVEF≥55%； Bone marrow function：neutrophils (≥1.5×10^9/L), platelets (≥100×10^9/L), hemoglobin (≥90 g/L); Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN; Patients had good compliance with the planned treatment, understood the research process and written informed consent. Exclusion Criteria: Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy; Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores; Patients with severe systemic infection or other serious diseases; Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants; Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer; Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial; Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given; The researchers considered the patients who were not suitable for enrollment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cuizhi Geng, M.D.

Phone

0311-6669 6310

gengcuizhi@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zefei Jiang, M.D.

Organizational Affiliation

Beijing 302 Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Cuizhi Geng, M.D.

Organizational Affiliation

The Fourth Hospital of Hebei Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

The Fourth Hospital of Hebei Medical University

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cuizhi Geng, M.D.

Phone

0311-6669 6310

gengcuizhi@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer

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