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

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ClinicalTrials.gov Identifier: NCT04159142
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
The fifth medical center of PLA general hospital
CSPC Ouyi Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Cuizhi GENG, Hebei Medical University Fourth Hospital

Tracking Information
First Submitted Date  ICMJE October 23, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date November 12, 2019
Estimated Study Start Date  ICMJE November 20, 2019
Estimated Primary Completion Date June 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
Progression free survival (PFS) [ Time Frame: 3 years ]
Up to disease progression or death due to any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • PFS rate for 6 cycles [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]
    From the date of randomization to the end of 6 cycles
  • Objective response rate (ORR) [ Time Frame: 3 years ]
    To evaluate the Overall Response Rate of patients with advanced triple-negative breast cancer
  • Overall survival (OS) [ Time Frame: 3 years ]
    To evaluate the overall survival of patients with advanced triple-negative breast cancer
  • Adverse events (AE) [ Time Frame: 3 years ]
    To evaluate the adverse events of patients with advanced triple-negative breast cancer
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
Official Title  ICMJE Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Triple Negative Breast Cancer
  • Nab-paclitaxel
Intervention  ICMJE
  • Drug: Nab-paclitaxel + Carboplatin
    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;
  • Drug: Nab-paclitaxel + Capecitabine
    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;
Study Arms  ICMJE
  • Experimental: Nab-paclitaxel + Carboplatin
    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;
    Intervention: Drug: Nab-paclitaxel + Carboplatin
  • Experimental: Nab-paclitaxel + Capecitabine
    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: Drug: Nab-paclitaxel + Capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2019)
414
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 20, 2022
Estimated Primary Completion Date June 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cuizhi Geng, M.D. 0311-6669 6310 gengcuizhi@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04159142
Other Study ID Numbers  ICMJE CSPC-KAL-BC-16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cuizhi GENG, Hebei Medical University Fourth Hospital
Study Sponsor  ICMJE Hebei Medical University Fourth Hospital
Collaborators  ICMJE
  • The fifth medical center of PLA general hospital
  • CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators  ICMJE
Study Chair: Zefei Jiang, M.D. The fifth medical center of PLA general hospital
Study Chair: Cuizhi Geng, M.D. The Fourth Hospital of Hebei Medical University
PRS Account Hebei Medical University Fourth Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP