Image

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

Recruiting
18 - 75 years of age
Female
Phase 2

Powered by AI

Overview

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.

Eligibility

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

Study details

Breast Cancer

NCT05891561

Shanghai Jiao Tong University School of Medicine

20 March 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.