Short-course treatment for early HER2-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II, open-label, single-arm clinical study investigates the effectiveness of a short-course regimen combining trastuzumab and pertuzumab with taxanes for patients with early HER2-positive breast cancer. The goal is to determine if four courses of this dual HER2 blockade can achieve similar outcomes to the standard one-year trastuzumab monotherapy while minimizing adverse effects. Participants will receive the treatment and be monitored for their response and side effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaosong Chen
• Email: chenxiaosong0156@hotmail.com
• Phone: +8621-64370045*602102

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using blood ctDNA to compare two pre-surgery HER2-positive breast cancer regimens

  We will test whether two different pre-surgery drug combinations clear tumor DNA from the blood better in people with HER2-positive early breast cancer.

  Recruiting Phase 2 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07335081

• TQB2102 versus docetaxel with trastuzumab and pertuzumab for HER2-positive recurrent or metastatic breast cancer

  This trial will test whether TQB2102 works as well as docetaxel plus trastuzumab and pertuzumab for adults with HER2-positive recurrent or metastatic breast cancer.

  Recruiting Phase 3 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Hefei, Anhui and 24 other locations · NCT07003074

• Vaccine targeting HER2 in locally advanced breast cancer

  This trial will test a vaccine that boosts the immune system to attack HER2-positive breast cancer in adults with locally advanced or high-risk disease.

  Recruiting Phase 1 Indiana University · Indianapolis, Indiana · NCT06949410

• Neoadjuvant treatment for HER2-positive breast cancer without chemotherapy

  This study is testing a new treatment using tucatinib, trastuzumab, and pertuzumab for people with stage II-III HER2-positive breast cancer to see if they can be treated without chemotherapy.

  Recruiting Phase 1 The Netherlands Cancer Institute · Amsterdam · NCT06162559

• Combination treatment for HR+/HER2+ breast cancer

  This study is testing a new combination treatment for patients with stage II-III HR+/HER2+ breast cancer to see if it works better than the standard treatment before surgery.

  Recruiting Phase 2 Shengjing Hospital · Shenyang, Liaoning · NCT05638594

• Comparing two treatment regimens for HER-2 positive breast cancer

  This study is testing two different treatment plans for people with HER-2 positive breast cancer to see which one works better before surgery.

  Recruiting Phase 3 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guandong, Guangdong · NCT05159193

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.