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Active, not recruiting

NCT Number: NCT03980054

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Cancer Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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) .

Exclusion criteria

  • 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.

Treatment and study plan

Pyrotinib

Drug

pyrotinib 400 mg, orally once daily for one year

Placebo

Drug

placebo 400mg, orally once daily for one year

Primary outcomes

  1. Invasive Disease-free Survival (iDFS)

    Time frame: From randomization until time of event up to 2 years

    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 outcomes

  1. Disease-free Survival (DFS)

    Time frame: From randomization until time of event up to 2 years

    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.

  2. Overall Survival (OS)

    Time frame: up to 2 years

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

  3. Distance Disease-free Survival (DDFS)

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

    Distance Disease-free Survival is defined as the time from date of randomization until the first distant recurrence and death from any cause.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase III Study to Evaluate the Efficacy and Safety of Pyrotinib Versus Placebo in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2019
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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