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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib

Paclitaxel

Cisplatin

Surgery

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Apatinib, Neoadjuvant chemotherapy, Breast cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

18~70 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

Exclusion Criteria:

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

Sites / Locations

Renji Hospital, School of Medicine, Shanghai Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

Apatinib+Paclitaxel+Cisplatin

Paclitaxel+Cisplatin

Outcomes

Primary Outcome Measures

Residual cancer burden (RCB 0-I rates）

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

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.

Secondary Outcome Measures

pCR in the Breast and Nodes

Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.

Near pCR in the Breast

Percentage of patients with the residual breast lump Less than 10%

Clinical and imaging response

To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment

Number of Participants With Drug Related Treatment Adverse Events

Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state.

Neo-bioscore

The Neo-Bioscore staging points were determined for each patient based on information from the medical records according to the previously published work（Mittendorf EA, et al. The Neo-Bioscore Update for Staging Breast Cancer Treated With Neoadjuvant Chemotherapy: Incorporation of Prognostic Biologic Factors Into Staging After Treatment. JAMA Oncol. United States; 2016;2:929-36.）. Neo-Bioscore = Clinical stages score + Pathological stages score + Tumor marker score Clinical stage I =0, Clinical stage IIA =0, Clinical stage IIB =1, Clinical stage IIIA =1, Clinical stage IIIB =2, Clinical stage IIIC =2, Pathological stage 0 =0, Pathological stage I =0, Pathological stage IIA =1, Pathological stage IIB =1, Pathological l stage IIIA =1, Pathological stage IIIB =1, Pathological stage IIIC =2, Tumor marker ER negative=1 Tumor marker Grade3=1 Tumor marker ERBB2 negative=1

Disease-free Survival (DFS)

DFS is defined as the time period between registration and first event

Distant-disease- free survival (DDFS)

DDFS is defined as the time period between registration and first event

Overall survival (OS)

OS is defined as the time period between registration and first event

Full Information

NCT ID

NCT03982485

First Posted

April 10, 2019

Last Updated

December 18, 2021

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03982485

Brief Title

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

Acronym

APP

Official Title

Neoadjuvant Apatinib Added to Weekly Paclitaxel and Cisplatin in Patient With Locally Advanced or Early Stage HER2 Negative Breast Cancer (APP) : a Open-label, Randomized, Controlled, Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 16, 2018 (Actual)

Primary Completion Date

October 16, 2022 (Anticipated)

Study Completion Date

April 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Apatinib, Neoadjuvant chemotherapy, Breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Apatinib+Paclitaxel+Cisplatin

Arm Title

Arm II

Arm Type

Active Comparator

Arm Description

Paclitaxel+Cisplatin

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Surgery

Intervention Description

Surgery

Primary Outcome Measure Information:

Title

Residual cancer burden (RCB 0-I rates）

Description

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

Time Frame

Time of surgery

Title

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

Description

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

Time Frame

Time of surgery

Secondary Outcome Measure Information:

Title

pCR in the Breast and Nodes

Description

Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.

Time Frame

Time of surgery

Title

Near pCR in the Breast

Description

Percentage of patients with the residual breast lump Less than 10%

Time Frame

Time of surgery

Title

Clinical and imaging response

Description

To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment

Time Frame

Time of surgery

Title

Number of Participants With Drug Related Treatment Adverse Events

Description

Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state.

Time Frame

an average of 16 weeks

Title

Neo-bioscore

Description

Time Frame

Time of surgery

Title

Disease-free Survival (DFS)

Description

DFS is defined as the time period between registration and first event

Time Frame

Measured through 5 years after study enrollment

Title

Distant-disease- free survival (DDFS)

Description

DDFS is defined as the time period between registration and first event

Time Frame

Measured through 5 years after study enrollment

Title

Overall survival (OS)

Description

OS is defined as the time period between registration and first event

Time Frame

Measured through 5 years after study enrollment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18~70 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yaohui Wang, MD

Phone

+862168385569

bearwangyh@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinsong Lu, MD

Organizational Affiliation

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jinsong Lu, MD

lujjss@163.com

First Name & Middle Initial & Last Name & Degree

Jinsong Lu, MD

12. IPD Sharing Statement

Learn more about this trial

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

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