Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer

NCT03982485 | Active Not Recruiting Phase 2

• 1 other identifier: SHPD005
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients. Apatinib is a highly potent human vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor that has been independently developed in China, and it can exert anti-angiogenic effects by inhibiting VEGFR2. It is unknown whether giving combination neoadjuvant chemotherapy together with apatinib is more effective in treating patients with nonmetastatic HER2-negative breast cancer. PURPOSE: To explore the efficacy and safety of apatinib added to weekly paclitaxel and cisplatin neoadjuvant therapy for HER-2 negative breast cancer patients

Conditions

Breast Cancer

Keywords

Apatinib; Neoadjuvant chemotherapy; Breast cancer

Outcome Measures

Primary Outcomes (2)

• Residual cancer burden (RCB 0-I rates）

  RCB 0-I rates means RCB 0+I (good response) rates.

  Time of surgery

• Pathologic Complete Response (pCR) of the Primary Tumor in the Breast

  Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.

  Time of surgery

Secondary Outcomes (8)

• pCR in the Breast and Nodes

  Time of surgery

• Near pCR in the Breast

  Time of surgery

• Clinical and imaging response

  Time of surgery

• Number of Participants With Drug Related Treatment Adverse Events

  an average of 16 weeks

• Neo-bioscore

  Time of surgery

Study Arms (2)

Arm I

EXPERIMENTAL

Apatinib+Paclitaxel+Cisplatin

Drug: Apatinib; Drug: Paclitaxel; Drug: Cisplatin; Procedure: Surgery

Arm II

ACTIVE COMPARATOR

Paclitaxel+Cisplatin

Drug: Paclitaxel; Drug: Cisplatin; Procedure: Surgery

Interventions

Apatinib DRUG

Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week

Arm I

Paclitaxel DRUG

Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle

Arm I; Arm II

Cisplatin DRUG

Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle

Arm I; Arm II

Surgery PROCEDURE

Surgery

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~70 year-old，Female
• Patients with histologically confirmed primary invasive breast adenocarcinoma,cT2-4N0-3M0
• ECOG 0-1
• HER2-negative tumor in biopsy, defined as: Immunohistochemical (IHC) 0-1+ or IHC 2+ confirmed as FISH negative.
• Adequate organ function

You may not qualify if:

• Unwilling to use adequate contraceptive protection during the process of the study and for at least 8 weeks after the last dose of study drug.
• Pregnant or breastfeeding patients
• Metastatic or recurrent patients
• Any evidence of sense or motor nerve disorders
• Any concurrent malignancy other than breast cancer
• Uncontrolled hypertension with hypotensive drugs therapy (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg). Patients with grade I or above myocardial ischemia or myocardial infarction or arrhythmia (including QT interval ≥ 440 ms) or cardiac insufficiency
• Inability to swallow, gastrointestinal resection, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption
• Coagulation disorders
• Artery or venous thrombosis occurred within 6 months before the study begins
• Have received prior treatment with a VEGFR TKI

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

apatinib; Paclitaxel; Cisplatin; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jinsong Lu, MD

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: June 11, 2019
• Study Start: October 16, 2018
• Primary Completion: March 29, 2023
• Study Completion (Estimated): March 29, 2031
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

CN (1)