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Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer

Primary Purpose

Breast Cancer Female, HER2-positive Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pyrotinib
Trastuzumab
Aromatase Inhibitors
Sponsored by
Fuzhou General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

  • Fuzhou general hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pyrotinib and trastuzumab plus aromatase inhibito

Arm Description

Participants will receive pyrotinib in combination with trastuzumab plus AI until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.

Secondary Outcome Measures

Objective Overall Response Rate (ORR)
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable. The ORR will be reported by percentage with each arms and appropriate confidence intervals.
Duration of Response (DoR)
DoR is defined as date of initial confirmed PR/CR until date of progressive disease or death from any cause. PR or CR or SD is according to RECIST version 1.1. The DoR will be estimated using Kaplan-Meier method. Kaplan-Meier curves, median DoR, hazard ratio with appropriate confidence intervals will be reported.
Overall Survival (OS)
Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication and participants with no post-baseline information were censored at the date of randomization. The OS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.

Full Information

First Posted
September 11, 2019
Last Updated
September 11, 2019
Sponsor
Fuzhou General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04088110
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuzhou General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, HER2-positive Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Metastatic Breast Cancer, Breast Diseases, Hormone Receptor Positive Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pyrotinib and trastuzumab plus aromatase inhibito
Arm Type
Experimental
Arm Description
Participants will receive pyrotinib in combination with trastuzumab plus AI until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
Pyrotinib
Other Intervention Name(s)
Study drug
Intervention Description
Pyrotinib were administered 400 mg orally daily. Oral administration within 30 minutes after breakfast, and continuous administration for 21 days for 1 cycle.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin®
Intervention Description
Trastuzumab were administered every 3 weeks intravenously (8 mg/kg loading doses followed by 6 mg/kg maintenance doses).
Intervention Type
Drug
Intervention Name(s)
Aromatase Inhibitors
Other Intervention Name(s)
anastrozole, letrozole or exemestane
Intervention Description
The investigator chose an aromatase inhibitor (either anastrozole, letrozole or exemestane 1 mg/2.5 mg/25 mg), once daily, oral.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.
Time Frame
From randomization to 36 month
Secondary Outcome Measure Information:
Title
Objective Overall Response Rate (ORR)
Description
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable. The ORR will be reported by percentage with each arms and appropriate confidence intervals.
Time Frame
From randomization to 36 month
Title
Duration of Response (DoR)
Description
DoR is defined as date of initial confirmed PR/CR until date of progressive disease or death from any cause. PR or CR or SD is according to RECIST version 1.1. The DoR will be estimated using Kaplan-Meier method. Kaplan-Meier curves, median DoR, hazard ratio with appropriate confidence intervals will be reported.
Time Frame
From randomization to 36 month
Title
Overall Survival (OS)
Description
Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication and participants with no post-baseline information were censored at the date of randomization. The OS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.
Time Frame
From randomization to 36 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≥18 years,≤70 years, female; Postmenopausal or pre-menopausal with ovarian function suppression; with or without measurable lesion evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1; Metastatic or inoperable local advanced Invasive breast cancer; HER2-positive breast cancer; HR-positive breast cancer; LVEF ≥55%;QT interva<470 ms; Eastern Cooperative Oncology Group(ECOG) scale 0-1; Life expectancy ≥3 months; Exclusion Criteria: Previous systemic non-hormonal anticancer therapy in the metastatic or advanced breast cancer setting; Received endocrine therapy within 7 days before randomization;Uncontrolled central nervous system metastases; Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months. Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma. 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 Severe organ dysfunction as assessed by signs and symptoms, laboratory studies and rapid progression of disease, which leading to a clinical indication for chemotherapy. History of CHF of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (exception, atrial fibrillation, paroxysmal supraventricular tachycardia); History of myocardial infarction within 6 months of randomization; History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy; Pregnant or lactating women; QT interval>470 ms; 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Xi, PhD
Phone
13705045925
Ext
13705045925
Email
cxifuzhou@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Xi, PhD
Organizational Affiliation
Fuzhou General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fuzhou general hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
365000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer

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