Adjuvant Dual Anti-HER2 Therapy in Patients With Small, Node-negative, HER2-positive Breast Cancer

NCT04158856 | Not Yet Recruiting Phase 2

• 1 other identifier: SHERO
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase II trial aims to study the efficacy and safety of adjuvant Pyrotinib plus trastuzumab in patients with tumors \<8mm, node-negative, HER2-positive breast cancer.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival

  stimated percentage of patients alive and disease-free at 5 years from randomization or censored at date of last follow-up.

  5 years

Secondary Outcomes (4)

• Breast Cancer Specific Survival

  5 years

• Overall Survival

  5 years

• Treatment-related adverse events

  up to 3 months

• Change of LVEF after treatment

  up to 3 months

Study Arms (1)

Experimental Arm

EXPERIMENTAL

adjuvant Pyrotinib plus Trastuzumab

Drug: Pyrotinib; Drug: Trastuzumab

Interventions

Pyrotinib DRUG

400mg po every day

Also known as: Pyrotinib Maleate Tablets

Experimental Arm

Trastuzumab DRUG

Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days

Also known as: Herceptin

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18-70 years old
• Have finished radical operation
• Histologically confirmed invasive ductal carcinoma (IDCA)
• According to AJCC ,pT\<8mm, pN0, no evidence for metastasis
• Operation specimens are available for ER, progesterone receptor (PR) and HER2 detection, patients should be HER2 positive tumor (IHC staining of 3+ \[uniform, intense membrane staining of \>30% of invasive tumor cells\], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio \[HER2 gene signals to chromosome 17 signals\] of \>2.2), nuclear grade 3.
• Should have tumor tissue available and sufficient for multi-spots sampling.
• It has been \<84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician.
• Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1, expected survival time \> 12 months
• Cardiac function had to be within normal limits (left ventricular ejection fraction \[LVEF\] ≥50%), as established by multiple gated acquisition scan or echocardiography.
• Adequate bone marrow function, adequate liver and renal function, and adequate coagulation function.
• Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study.
• Written informed consent according to the local ethics committee requirements.

You may not qualify if:

• pT≥8mm or node positive
• Metastatic breast cancer
• Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
• With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
• Patients with medical conditions that indicate intolerant to adjuvant target therapy and related treatment, including severe infection, coagulation disorder, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
• Has symptomatic peripheral neuropathy \> grade 2 according to NCI
• Known severe allergy to any drugs in this study
• Has cardiac dysfunction or lung dysfunction defined as follows:
• grade ≥3 CHF according to NCI CTCAE v 5.0 or NYHA≥II
• angina which requires drug control, cardiac infraction, and any other vascular disease with apparent clinical symptoms
• uncontrolled high-risk arrhythmia
• uncontrolled hypertension
• Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
• Patient is pregnant or breast feeding

Sponsors & Collaborators

• xuexin he: lead

MeSH Terms

Interventions

pyrotinib; Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xuexin He, MD

  Seaond Affiliated Hospital, Zhejiang University, School of Medicine

  STUDY CHAIR

Central Study Contacts

Xuexin He, MD

CONTACT

+86-18329139569; xuexinhe@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: June 1, 2020
• Primary Completion: May 31, 2023
• Study Completion (Estimated): May 31, 2030
• Last Updated: November 12, 2019

Record last verified: 2019-11