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

Summary

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

Conditions2

Interventions1

Related trials

• A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer — Shanghai JMT-Bio Inc.
• A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer — Shanghai JMT-Bio Inc.
• A Study for the Adjuvant Treatment of Breast Cancer — Second Affiliated Hospital, School of Medicine, Zhejiang University
• A Study for the Neoadjuvant Treatment of Breast Cancer — Second Affiliated Hospital, School of Medicine, Zhejiang University
• A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer — Sichuan Baili Pharmaceutical Co., Ltd.
• Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer — AC Camargo Cancer Center
• DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With HER2 Amplification or Activating Mutations — Cancer Research UK
• Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer — Sun Yat-sen University

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