Back to results

Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer (ATP)

Primary Purpose

Locally Advanced Breast Cancer

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

pyrotinib

About this trial

This is an interventional treatment trial for Locally Advanced Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

Female, Aged ≥18 and ≤70 years;
Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ;
Completed neoadjuvant therapy, including chemotherapy and trastuzumab;
Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy;
Been or being treated for early breast cancer with standard of care duration of trastuzumab;
Adjuvant treatment regimen needs to be determined before randomization;
Duration from Random time to the last use of trastuzumab≤1 year.
Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
Required laboratory values including following parameters:ANC: ≥ 1.5 x 109/L; Platelet count: ≥ 100 x 109/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal, ULN; ALT and AST: ≤ 1.5 x ULN; BUN and creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: < 470 ms
Signed informed consent form (ICF) .

Exclusion Criteria:

Metastatic disease (Stage IV) ;
Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
Progressive disease during neoadjuvant therapy;
Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib.
Less than 4 weeks from the last clinical trial;
History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial;
Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period;
Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Sites / Locations

Renji Hospital, School of Medicine, Shanghai Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pyrotinib

No Pyrotinib

Arm Description

pyrotinib 400 mg, orally once daily for one year

Observation follow-up

Outcomes

Primary Outcome Measures

Invasive Disease-free Survival (iDFS)

Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.

Secondary Outcome Measures

Disease-free Survival (DFS)

Disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ(DCIS),or distant recurrence and death from any cause

Overall Survival (OS)

Overall survival is defined as the time from randomization to death from any cause.

Full Information

NCT ID

NCT04254263

First Posted

February 1, 2020

Last Updated

August 11, 2022

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04254263

Brief Title

Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

Acronym

ATP

Official Title

Adjuvant Trastuzumab Plus Pyrotinib for Residual Invasive HER2-positive Breast Cancer After Neoadjuvant Chemotherapy Plus Anti-HER2 Target Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 16, 2019 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

August 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.

6. Conditions and Keywords

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

Locally Advanced Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

316 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pyrotinib

Arm Type

Experimental

Arm Description

pyrotinib 400 mg, orally once daily for one year

Arm Title

No Pyrotinib

Arm Type

No Intervention

Arm Description

Observation follow-up

Intervention Type

Drug

Intervention Name(s)

pyrotinib

Intervention Description

pyrotinib 400 mg, orally once daily for one year

Primary Outcome Measure Information:

Title

Invasive Disease-free Survival (iDFS)

Description

Time Frame

From randomization until time of event up to 2 years.

Secondary Outcome Measure Information:

Title

Disease-free Survival (DFS)

Description

Time Frame

From randomization until time of event up to 2 years

Title

Overall Survival (OS)

Description

Overall survival is defined as the time from randomization to death from any cause.

Time Frame

From randomization until time of event up to 2 years

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: Female, Aged ≥18 and ≤70 years; Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ; Completed neoadjuvant therapy, including chemotherapy and trastuzumab; Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy; Been or being treated for early breast cancer with standard of care duration of trastuzumab; Adjuvant treatment regimen needs to be determined before randomization; Duration from Random time to the last use of trastuzumab≤1 year. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1; Required laboratory values including following parameters:ANC: ≥ 1.5 x 109/L; Platelet count: ≥ 100 x 109/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal, ULN; ALT and AST: ≤ 1.5 x ULN; BUN and creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: < 470 ms Signed informed consent form (ICF) . Exclusion Criteria: Metastatic disease (Stage IV) ; Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery; Progressive disease during neoadjuvant therapy; Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption; Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib. Less than 4 weeks from the last clinical trial; History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation; Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial; Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period; Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Central Contact Person:

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

Wenjin Yin

Phone

86(21)68385569

followroad@163.com

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

Qi Lu

Phone

86(21)68383364

rjllb3364@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinsong Lu

Organizational Affiliation

RenJi Hospital

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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

We'll reach out to this number within 24 hrs