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

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

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.

Study Overview

• Status: Unknown
• Conditions: Systematic Review of the pCR Rate of Apatinib Combined With Albumin Paclitaxel and Carboplatin Regimen for Neoadjuvant Therapy of Triple-negative Breast Cancer
• Intervention / Treatment: Drug: Apatinib

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Jiangsu Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR rate	The treatment regimen was used for a total of 6 cycles, or to PD, or the toxicity was not tolerated.	4 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Protein Kinase Inhibitors; Carboplatin; Paclitaxel; Apatinib
• Other Study ID Numbers: BL2014084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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