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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Nab-paclitaxel Drug: Nab-paclitaxel + Carboplatin Drug: Nab-paclitaxel + Capecitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
Estimated Study Start Date : November 20, 2019
Estimated Primary Completion Date : June 20, 2022
Estimated Study Completion Date : September 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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;
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;

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;
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;




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 3 years ]
    Up to disease progression or death due to any cause


Secondary Outcome Measures :
  1. 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

  2. Objective response rate (ORR) [ Time Frame: 3 years ]
    To evaluate the Overall Response Rate of patients with advanced triple-negative breast cancer

  3. Overall survival (OS) [ Time Frame: 3 years ]
    To evaluate the overall survival of patients with advanced triple-negative breast cancer

  4. Adverse events (AE) [ Time Frame: 3 years ]
    To evaluate the adverse events of patients with advanced triple-negative breast cancer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159142


Contacts
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Contact: Cuizhi Geng, M.D. 0311-6669 6310 gengcuizhi@hotmail.com

Locations
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China, Hebei
The Fourth Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050011
Contact: Cuizhi Geng, M.D.    0311-6669 6310    gengcuizhi@hotmail.com   
Sponsors and Collaborators
Hebei Medical University Fourth Hospital
The fifth medical center of PLA general hospital
CSPC Ouyi Pharmaceutical Co., Ltd.
Investigators
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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
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Responsible Party: Cuizhi GENG, Principal Investigator, Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT04159142    
Other Study ID Numbers: CSPC-KAL-BC-16
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cuizhi GENG, Hebei Medical University Fourth Hospital:
Nab-paclitaxel
Carboplatin
Capecitabine
Triple Negative Breast Cancer
Maintenance therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Capecitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites