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

Phase 2

Not yet recruiting

• Conditions: HER2-positive Breast Cancer
• Interventions: Drug: Pyrotinib; Drug: Trastuzumab

• Registration Number: NCT04158856
• Lead Sponsor: xuexin he

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-07
• Last Update Submitted: 2019-11-07
• Study First Posted: 2019-11-12
• Last Update Posted: 2019-11-12
• Study Start: 2020-06-01
• Primary Completion: 2023-05-31
• Study Completion: 2030-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Trastuzumab	adjuvant Pyrotinib plus Trastuzumab
Experimental Arm	Pyrotinib	adjuvant Pyrotinib plus Trastuzumab

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Breast Cancer Specific Survival	5 years	Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer specific survival is defined as the time from randomization to death from breast cancer relapse; or censored at date last known alive.
Overall Survival	5 years	Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
Treatment-related adverse events	up to 3 months	Incidence and severity of adverse events as assessed by NCI CTCAE V5.0
Change of LVEF after treatment	up to 3 months	The change of LVEF after 3 months treatment compared to the baseline LVEF