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Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

Primary Purpose

Triple Negative Breast Cancer, Nab-paclitaxel

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nab-paclitaxel + Carboplatin
Nab-paclitaxel + Capecitabine
Sponsored by
Hebei Medical University Fourth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Nab-paclitaxel, Carboplatin, Capecitabine, Triple Negative Breast Cancer, Maintenance therapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Females with age between 18 to 70 years old;
  2. Histologically confirmed triple negative breast cancer;
  3. No more than one-line prior treatment for locally advanced or metastatic breast cancer;
  4. Have at least one measurable lesion as per the RECIST criteria (version 1.1);
  5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
  6. Patients with life expectancy of at least 3 months;
  7. Bone marrow function：neutrophils (≥1.5×10^9/L), platelets (≥100×10^9/L), hemoglobin (≥90 g/L);
  8. 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;
  9. Patients had good compliance with the planned treatment, understood the research process and written informed consent.

Exclusion Criteria:

  1. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
  2. Brain metastasis;
  3. Recurrence or metastasis within 6 months after capecitabine withdrawal;
  4. Recurrence or metastasis within 6 months after platinum withdrawal;
  5. Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;
  6. Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding;
  7. Patients who had Grade 2 or above Peripheral neuropathy;
  8. Patients with severe systemic infection or other serious diseases;
  9. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
  10. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
  11. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
  12. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
  13. 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

Experimental

Arm Label

Nab-paclitaxel + Carboplatin

Nab-paclitaxel + Capecitabine

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； Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;

Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and capecitabine given IV at 1000 mg/m^2 bid, d1-14 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
Up to disease progression or death due to any cause

Secondary Outcome Measures

PFS rate for 6 cycles
From the date of randomization to the end of 6 cycles
Objective response rate (ORR)
To evaluate the Overall Response Rate of patients with advanced triple-negative breast cancer
Overall survival (OS)
To evaluate the overall survival of patients with advanced triple-negative breast cancer
Adverse events (AE)
To evaluate the adverse events of patients with advanced triple-negative breast cancer

Full Information

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.
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1. Study Identification

Unique Protocol Identification Number
NCT04159142
Brief Title
Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
Official Title
Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative 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
June 20, 2022 (Anticipated)
Study Completion Date
September 20, 2022 (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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a multi-center , open-lable clinical trial. 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. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer, Nab-paclitaxel
Keywords
Nab-paclitaxel, Carboplatin, Capecitabine, Triple Negative Breast Cancer, Maintenance therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (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； Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;
Arm Title
Nab-paclitaxel + Capecitabine
Arm Type
Experimental
Arm Description
Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and capecitabine given IV at 1000 mg/m^2 bid, d1-14 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;
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 + Capecitabine
Intervention Description
Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and capecitabine given IV at 1000 mg/m^2 bid, d1-14 every 21 days x 6 cycles；
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
Up to disease progression or death due to any cause
Time Frame
3 years
Secondary Outcome Measure Information:
Title
PFS rate for 6 cycles
Description
From the date of randomization to the end of 6 cycles
Time Frame
At the end of Cycle 6 (each cycle is 21 days)
Title
Objective response rate (ORR)
Description
To evaluate the Overall Response Rate of patients with advanced triple-negative breast cancer
Time Frame
3 years
Title
Overall survival (OS)
Description
To evaluate the overall survival of patients with advanced triple-negative breast cancer
Time Frame
3 years
Title
Adverse events (AE)
Description
To evaluate the adverse events of patients with advanced triple-negative breast cancer
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
No
Eligibility Criteria
Inclusion Criteria: Females with age between 18 to 70 years old; Histologically confirmed triple negative breast cancer; No more than one-line prior treatment for locally advanced or metastatic breast cancer; 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; Patients with life expectancy of at least 3 months; 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: Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores; Brain metastasis; Recurrence or metastasis within 6 months after capecitabine withdrawal; Recurrence or metastasis within 6 months after platinum withdrawal; Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months; Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding; Patients who had Grade 2 or above Peripheral neuropathy; 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
Email
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
Email
gengcuizhi@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

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