Breast Cancer FemalePhase 2NCT04088110
Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer
A Phase 2 study testing Pyrotinib, Trastuzumab and Aromatase Inhibitors in people with Breast Cancer Female and HER2-positive Breast Cancer, run by Fuzhou General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Female, HER2-positive Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast
- What is being tested?
- Pyrotinib, Trastuzumab and Aromatase Inhibitors
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- Nov 2019to Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- LVEF ≥55%;QT interva<470 ms;
- Eastern Cooperative Oncology Group(ECOG) scale 0-1;
- Life expectancy ≥3 months;
Who cannot join
- 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.
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer Female, HER2-positive Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Metastatic Breast Cancer, Breast Diseases, Hormone Receptor Positive Tumor
- Being tested
- Pyrotinib, Trastuzumab, Aromatase Inhibitors
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
Also called Study drug
Pyrotinib were administered 400 mg orally daily. Oral administration within 30 minutes after breakfast, and continuous administration for 21 days for 1 cycle.
TrastuzumabDrug
Also called Herceptin®
Trastuzumab were administered every 3 weeks intravenously (8 mg/kg loading doses followed by 6 mg/kg maintenance doses).
Aromatase InhibitorsDrug
Also called anastrozole, letrozole or exemestane
The investigator chose an aromatase inhibitor (either anastrozole, letrozole or exemestane 1 mg/2.5 mg/25 mg), once daily, oral.
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib and trastuzumab plus aromatase inhibito | Experimental | 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. Receives: Drug: Pyrotinib; Drug: Trastuzumab; Drug: Aromatase Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to 36 month
Secondary outcomes (3)
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.
Measured: From randomization to 36 month
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.
Measured: From randomization to 36 month
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.
Measured: From randomization to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study startNov 2019 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Xi, PhD, Study chair, Fuzhou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088110
- Sponsor's protocol ID
- Arise-FJ-B102
- Status last verified
- Sep 2019
- First submitted
- 11 Sep 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04088110
- Acronym / sponsor ID
- Arise-FJ-B102
- Conditions
- Breast Cancer Female, HER2-positive Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Metastatic Breast Cancer, Breast Diseases, Hormone Receptor Positive Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib and trastuzumab plus aromatase inhibito | Experimental | Drug: Pyrotinib, Drug: Trastuzumab, Drug: Aromatase InhibitorsParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyrotinibAlso: Study drugPyrotinib were administered 400 mg orally daily. Oral administration within 30 minutes after breakfast, and continuous administration for 21 days for 1 cycle. | Drug | Pyrotinib and trastuzumab plus aromatase inhibito |
| TrastuzumabAlso: Herceptin®Trastuzumab were administered every 3 weeks intravenously (8 mg/kg loading doses followed by 6 mg/kg maintenance doses). | Drug | Pyrotinib and trastuzumab plus aromatase inhibito |
| Aromatase InhibitorsAlso: anastrozole, letrozole or exemestaneThe investigator chose an aromatase inhibitor (either anastrozole, letrozole or exemestane 1 mg/2.5 mg/25 mg), once daily, oral. | Drug | Pyrotinib and trastuzumab plus aromatase inhibito |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From randomization to 36 month
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.
3 secondary outcomes
Objective Overall Response Rate (ORR)
Time frame: From randomization to 36 month
Duration of Response (DoR)
Time frame: From randomization to 36 month
Overall Survival (OS)
Time frame: From randomization to 36 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Xi, PhD study chair
Fuzhou General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyrotinib, Trastuzumab and Aromatase Inhibitors in people with Breast Cancer Female and HER2-positive Breast Cancer, run by Fuzhou General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Xi, PhD (13705045925 ext. 13705045925, cxifuzhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From randomization to 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.