Clinical trial NCT04088110: Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer
Official title: Pyrotinib Maleate Combined With Trastuzumab Plus Aromatase Inhibitor in the First-line Treatment of Advanced HER2-positive/HR-positive Breast Cancer Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer Female
HER2-positive Breast Cancer
Hormone Receptor Positive Malignant Neoplasm of Breast
Metastatic Breast Cancer
Breast Diseases
Hormone Receptor Positive Tumor
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single-arm, open-label, phase II study, comparing the efficacy and safety of pyrotinib plus trastuzumab and aromatase inhibitors, in the treatment of HR (hormone receptor)+/HER2 (human epidermal growth factor receptor 2) + MBC and inoperable LABC patients.

Detailed description: This is a exploratory, single-arm, open-label,multicenter phase II trial. Our primary purpose is to compare that PFS of patients with pyrotinib plus trastuzumab and AI for HER2-positive and hormone receptor-positive MBC or locally advanced breast cancer (LABC).

In treatment period, patients will be administrated pyrotinib plus trastuzumab and aromatase inhibitors, every 21 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination.

The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.

Eligibility criteria: Inclusion Criteria:

1. Age≥18 years,≤70 years, female;
2. Postmenopausal or pre-menopausal with ovarian function suppression;
3. with or without measurable lesion evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1;
4. Metastatic or inoperable local advanced Invasive breast cancer;
5. HER2-positive breast cancer;
6. HR-positive breast cancer;
7. LVEF ≥55%;QT interva\<470 ms;
8. Eastern Cooperative Oncology Group(ECOG) scale 0-1;
9. Life expectancy ≥3 months;

Exclusion Criteria:

1. Previous systemic non-hormonal anticancer therapy in the metastatic or advanced breast cancer setting;
2. Received endocrine therapy within 7 days before randomization;Uncontrolled central nervous system metastases;
3. Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months.
4. Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma.
5. Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment
6. Severe organ dysfunction as assessed by signs and symptoms, laboratory studies and rapid progression of disease, which leading to a clinical indication for chemotherapy.
7. History of CHF of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (exception, atrial fibrillation, paroxysmal supraventricular tachycardia);
8. History of myocardial infarction within 6 months of randomization;
9. History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy;
10. Pregnant or lactating women;
11. QT interval\>470 ms;
12. Serious concomitant diseases (including severe hypertension, severe diabetes, active infection, thyroid disease, etc.) that are harmful to the patient's safety or affect the patient's completion of the study;

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From randomization to 36 month
Secondary outcomes:
measure: Objective Overall Response Rate (ORR)
timeFrame: From randomization to 36 month
measure: Duration of Response (DoR)
timeFrame: From randomization to 36 month
measure: Overall Survival (OS)
timeFrame: From randomization to 36 month
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fuzhou general hospital
state: Fujian
Study officials:
affiliation: Fuzhou General Hospital
name: Chen Xi, PhD
role: STUDY_CHAIR
References: