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

NCT03650738 | Unknown Phase 2 FDA Drug

• 1 other identifier: BL2014084
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Systematic Review of the pCR Rate of Apatinib Combined With Albumin Paclitaxel and Carboplatin Regimen for Neoadjuvant Therapy of Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• pCR rate

  The treatment regimen was used for a total of 6 cycles, or to PD, or the toxicity was not tolerated.

  4 months

Study Arms (1)

Study group

EXPERIMENTAL

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

Interventions

Apatinib DRUG

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.

Also known as: Carboplatin, albumin paclitaxel

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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);

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Provincial Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

apatinib; Carboplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Li Wei

CONTACT

13851603656; real.lw@163.com

Yin Yongmei

CONTACT

13951842727

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: September 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)