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Recruiting

NCT Number: NCT05891561

Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer

The investigators plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore whether 4 courses of dual HER2 blockade combined with taxanes can lead to a similar prognosis with current standard treatment, which is one-year trastuzumab monotherapy combined with chemotherapy, while reducing the adverse reactions of treatment.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Xiaosong Chen

CONTACT

+8621-64370045*602102

Yiwei Tong

CONTACT

+8621-64370045*602107

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically diagnosed unilateral primary invasive breast cancer patient with pT1, pN0, and M0 disease
  • HER2-positive, ie. immunohistochemistry [IHC] 3+ or IHC 2+ and fluorescence in situ hybridisation [FISH]-positive according to ASCO/CAP 2018 guidelines
  • complete clinical pathological information
  • Eastern Cooperative oncology Group [ECOG] 0-1
  • Currently not pregnant or breast-feeding
  • Fine organ function
  • Have good compliance with planned treatment, understand the study process and sign a written informed consent

Exclusion criteria

  • Bilateral or metastatic breast cancer
  • Receiving neoadjuvant treatment
  • Other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
  • Severe systemic infections or other serious illnesses
  • HIV infection, active hepatitis B or C infection
  • Known allergy to or intolerance to a therapeutic drug or its excipients
  • Prior history of chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason
  • Enrollment of another investigational study within 4 weeks prior to initial administration of the investigational treatment
  • Receiving live vaccine within 30 days prior to initial administration of the investigational treatment
  • History of mental illness or drug abuse that may affect compliance with the trial requirements
  • The researchers determine that the patients were not suitable for the study

Treatment and study plan

Pertuzumab

Drug

4 cycles of taxane, pertuzumab, trastuzumab

Primary outcomes

  1. Disease free survival [DFS]

    Time frame: 3 year

    Time from surgery to first proven loco-regional recurrence, distant recurrence, second non-breast malignancy, or death from any cause

Secondary outcomes

  1. Overall survival [OS]

    Time frame: 3 year

    Time from surgery to death from any cause

  2. Distant disease-free survival [DDFS]

    Time frame: 3 year

    Time from surgery to first proven distant recurrence, second non-breast malignancy, or death from any cause

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 3 year

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaosong Chen

CONTACT

[email protected]

+8621-64370045*602102

Yiwei Tong

CONTACT

[email protected]

+8621-64370045*602107

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Short-course Trastuzumab, Pertuzumab Combined with Taxanes in the Adjuvant Treatment of Early Human Epidermal Growth Factor Receptor 2-positive Breast Cancer: an Open-label, Single-arm Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2023
Registry last updated
Nov 27, 2024

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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