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

NCT ID: NCT04158856

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2030-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

adjuvant Pyrotinib plus Trastuzumab

Group Type: EXPERIMENTAL

Pyrotinib

Intervention Type: DRUG

400mg po every day

Trastuzumab

Intervention Type: DRUG

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

Interventions

Pyrotinib

400mg po every day

Intervention Type: DRUG

Trastuzumab

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

Intervention Type: DRUG

Other Intervention Names

Pyrotinib Maleate Tablets; Herceptin

Eligibility Criteria

Inclusion Criteria

1. Women aged 18-70 years old

2. Have finished radical operation

3. Histologically confirmed invasive ductal carcinoma (IDCA)

4. According to AJCC ,pT<8mm, pN0, no evidence for metastasis

5. 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.

6. Should have tumor tissue available and sufficient for multi-spots sampling.

7. It has been <84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician.

8. Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1, expected survival time > 12 months

9. Cardiac function had to be within normal limits (left ventricular ejection fraction [LVEF] ≥50%), as established by multiple gated acquisition scan or echocardiography.

10. Adequate bone marrow function, adequate liver and renal function, and adequate coagulation function.

11. 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.

12. Written informed consent according to the local ethics committee requirements.

Exclusion Criteria

1. pT≥8mm or node positive

2. Metastatic breast cancer

3. Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days

4. With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma

5. 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

6. Has symptomatic peripheral neuropathy > grade 2 according to NCI

7. Known severe allergy to any drugs in this study

8. 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

9. Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive

10. Patient is pregnant or breast feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

xuexin he

OTHER

Sponsor Role: lead

Responsible Party

xuexin he

Associate chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xuexin He, MD

Role: STUDY_CHAIR

Seaond Affiliated Hospital, Zhejiang University, School of Medicine

Central Contacts

Xuexin He, MD

Role: CONTACT

xuexinhe@zju.edu.cn

+86-18329139569

Other Identifiers

SHERO

Identifier Type: -

Identifier Source: org_study_id