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Trial record 2 of 3 for:    Recruiting, Not yet recruiting, Available Studies | Systematic review

This Study Was a Prospective, One-arm Open Phase II Clinical Trial. A Systematic Review of the pCR of Apatinib in Combination With the Albumin Paclitaxel and Carboplatin Regimens for the Neoadjuvant Therapy of Triple-negative Breast Cancer, as Well as the Safety of Treatment

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ClinicalTrials.gov Identifier: NCT03650738
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
This study was a prospective, one-arm open phase II clinical trial. A systematic review of the pCR of apatinib in combination with the albumin paclitaxel and carboplatin regimens for the neoadjuvant therapy of triple-negative breast cancer, as well as the safety of treatment, at the same time, relevant exploratory biomarker research is conducted.

Condition or disease Intervention/treatment Phase
Systematic Review of the pCR Rate of Apatinib Combined With Albumin Paclitaxel and Carboplatin Regimen for Neoadjuvant Therapy of Triple-negative Breast Cancer Drug: Apatinib Phase 2

Detailed Description:

Neoadjuvant program: apatinib 250mg oral d1-21; albumin paclitaxel 260mg/m2 intravenous drip d1; carboplatin AUC=5-6 intravenous drip d1; 21 days for 1 cycle. The treatment regimen was used for a total of 6 cycles, or to PD, or the toxicity was not tolerated. If there is still no PD after 6 cycles, the surgical approach is based on the tumor condition and the patient's wishes. If the condition progresses to terminate the treatment regimen, the patient may receive subsequent local or systemic treatment. The follow-up period was followed up to assess safety and effectiveness.

MAIN OBJECTIVE: To systematically evaluate the pCR rate of apatinib combined with albumin paclitaxel and carboplatin regimen for neoadjuvant therapy of triple-negative breast cancer Secondary objective: To evaluate the safety of apatinib combined with albumin paclitaxel and carboplatin in neoadjuvant therapy for triple-negative breast cancer, an exploratory biomarker study


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, One-arm Open Clinical Trial of Apatinib Combined With Albumin Paclitaxel and Carboplatin as a Neoadjuvant Therapy for the Safety and Efficacy of Triple-negative Breast Cancer
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Study group
apatinib 250mg oral d1-21; albumin paclitaxel 260mg/m2 intravenous drip d1; carboplatin AUC=5-6 intravenous drip d1; 21 days for 1 cycle. The treatment regimen was used for a total of 6 cycles, or to PD, or the toxicity was not tolerated.
Drug: Apatinib
Neoadjuvant program: apatinib 250mg oral d1-21; albumin paclitaxel 260mg/m2 intravenous drip d1; carboplatin AUC=5-6 intravenous drip d1; 21 days for 1 cycle. The treatment regimen was used for a total of 6 cycles, or to PD, or the toxicity was not tolerated.
Other Names:
  • Carboplatin
  • albumin paclitaxel




Primary Outcome Measures :
  1. pCR rate [ Time Frame: 4 months ]
    The treatment regimen was used for a total of 6 cycles, or to PD, or the toxicity was not tolerated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. The patient volunteers and signs an informed consent form. 2.age ≥18 years old, female; 3.Diagnosed as triple negative breast cancer by histopathology; 4.Did not receive systemic anti-tumor treatment; 5. The clinical stage is stage II-III; 6.There must be at least one measurable lesion (according to RECIST v1.1); 7.Physical condition ECOG PS: 0-1; 8.Expected survival time ≥ 3 months; 9.Laboratory tests meet the following criteria: Bone marrow function: absolute count of blood neutrophils (ANC) ≥1.5×109/L; platelet (PLT)≥100×109/L; hemoglobin (HB)≥90g/L; Liver function: serum total bilirubin (STB), combined bilirubin (CB) ≤ upper limit of normal (ULN) *1.5; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN*2.5; Renal function: serum creatinine (Cr) ≤ ULN; endogenous creatinine clearance (Ccr) ≥ 60 ml / min (calculated using the Cockcroft-Gault formula);

Exclusion Criteria:

  • 1.Major surgery within 4 weeks prior to enrollment, or surgical wounds have not healed; 2.Embolization and bleeding occurred within 4 weeks before enrollment; 3.Malignant tumors of other histological origins in the past 5 years, except for cured cervical carcinoma in situ and basal cell carcinoma or squamous cell carcinoma; 4.Severe cardiovascular disease, including hypertension (BP≥160/95mmHg) uncontrolled by medical treatment, unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure>NYHA II, severe heart rhythm Abnormalities and pericardial effusions; 5.Severe infection requires intravenous antibiotic, antifungal or antiviral treatment; 6.Suffering from mental illness, poor compliance; 7.Researchers believe that it is not suitable for inclusion.

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): NCT03650738


Contacts
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Contact: Li Wei 13851603656 real.lw@163.com
Contact: Yin Yongmei 13951842727

Locations
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China, Jiangsu
Jiangsu Provincial Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Tang Jinhai         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03650738     History of Changes
Other Study ID Numbers: BL2014084
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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
Apatinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors