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First-line Nab-paclitaxel Plus Cisplatin Plus Carilizumab in mTNBC Patients

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: NCT04537286
Recruitment Status : Recruiting
First Posted : September 3, 2020
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Biyun Wang, MD, Fudan University

Study Description
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Brief Summary:
To evaluate the efficacy and safety of nab-paclitaxel plus cisplatin plus carilizumab as first-line treatment in patients with metastatic triple-negative breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-arm, Open-Label, Phase II Study of Nab-paclitaxel Plus Cisplatin Plus Carilizumab as First-line Treatment in Patients With Metastatic Triple-negative Breast Cancer
Actual Study Start Date : August 25, 2020
Estimated Primary Completion Date : September 15, 2023
Estimated Study Completion Date : October 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)
Nab-paclitaxel 125 mg/m2，ivgtt，d1, 8 Cisplatin 75 mg/m2，ivgtt，d1 Carilizumab 200mg, ivgtt，d1，q2w
 Drug: nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)
Nab-paclitaxel 125 mg/m2，ivgtt，d1, 8 Cisplatin 75 mg/m2，ivgtt，d1 Carilizumab 200mg, ivgtt，d1，q2w


Outcome Measures
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Primary Outcome Measures :
  1. PFS [ Time Frame: 6 weeks ]
    Progression free survival

  2. Adverse events [ Time Frame: 6 weeks ]
    Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)


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

Inclusion Criteria:

  1. Female patients aged 18-70 years who had
  2. Metastatic TNBC. ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patient primary or metastatic tumor sections. Metastatic disease was confirmed by clinical, imaging, histological or cytological measures.
  3. Patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer.
  4. Patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment.
  5. At least one measurable lesion according to RECIST 1.1,
  6. ECOG performance status ≤ 1
  7. Life expectancy of more than 12 weeks
  8. Adequate organ and bone marrow function.

Exclusion Criteria:

  1. Patient of childbearing potential but unwilling to receive contraception.
  2. Radiation therapy of axial bone within 4 weeks before enrollment.
  3. Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody.
  4. Patients have active autoimmune diseases.
  5. Patients who need systemic corticosteroids (> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period.
  6. Symptomatic central nervous system (CNS) disease (patients with asymptomatic treated CNS metastases were permitted)
  7. Other malignant diseases within the past 5 years (patients with basal cell skin carcinoma and cervical carcinoma in situ were permitted)
  8. Uncontrolled infection.
Contacts and Locations
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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): NCT04537286


Contacts
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Contact: Biyun Wang, Professor +8613701748410 pro_wangbiyun@163.com

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Biyun Wang, Professor    +8613701748410    pro_wangbiyun@163.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Biyun Wang, Professor Fudan University
More Information
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Responsible Party: Biyun Wang, MD, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT04537286    
Other Study ID Numbers: YOUNGBC-11
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Shared patient information is not allowed by study center.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Cisplatin
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action