A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

NCT03980054 | Unknown Phase 3 DMC

• 1 other identifier: HR-BLTN-III-EBC
• Study Type: interventional
• Target: 1,192
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab. The main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization until time of event up to 2 years

Secondary Outcomes (3)

• Disease-free Survival (DFS)

  From randomization until time of event up to 2 years

• Overall Survival (OS)

  up to 2 years

• Distance Disease-free Survival (DDFS)

  distant recurrence From randomization until time of event up to 2 years

Study Arms (2)

Arm Pyrotinib

EXPERIMENTAL

Intervention: Drug: Pyrotinib

Drug: Pyrotinib

Arm Placebo

PLACEBO COMPARATOR

Intervention: Drug: Placebo

Drug: Placebo

Interventions

Pyrotinib DRUG

pyrotinib 400 mg, orally once daily for one year

Arm Pyrotinib

Placebo DRUG

placebo 400mg, orally once daily for one year

Arm Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients, 18 years ≤ age ≤ 75 years；
• Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
• Histologically confirmed invasive HER2 positive breast cancer.
• Known hormone receptor status.
• Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by Echocardiogram.
• Been treated for early breast cancer with standard of care duration of trastuzumab.
• If been not treated neoadjuvantly, lymph node metastases need to be confirmed by postoperative pathology; if been treated neoadjuvantly , have not reached totally pathologic complete response.
• Signed informed consent form (ICF) .

You may not qualify if:

• Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
• History of heart disease.
• Bilateral breast cancer.
• Corrected QT (QTc) interval ≥0.47 seconds.
• History of gastrointestinal disease with diarrhea as the major symptom.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhimin Shao

  Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pyrotinib versus Placebo

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: July 12, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2024
• Last Updated: May 24, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)