Breast CancerPhase 2PRETTYNCT04255056
Pyrotinib in Breast Cancer Patients With Poor Response to the Neoadjuvant Treatment of Trastuzumab and Pertuzumab
A Phase 2 study testing Pyrotinib in people with Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Pathological complete remission (pCR) after neoadjuvant therapy in HER2-positive early breast cancer patients is closely related to disease-free survival (DFS) and overall survival (OS), which makes pCR an important evaluation indicator of recurrence risk. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pyrotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 1 Feb 2025
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥ 18 years and ≤ 75 years;
- ECOG score 0-1;
- HER2-overexpressing breast cancer confirmed by immunohistochemical (IHC) analysis or in situ hybridization (ISH).
- The patient has received at least 3 cycles of neoadjuvant therapy with trastuzumab combined with pertuzumab and the clinical response is SD or PD (according to RECIST version 1.1) evaluated with breast MRI/CT/ultrasound.
- Known hormone receptor status (ER and PgR);
- The function of the main organs must meet the following requirements： 1) Blood routine: Neutrophil (ANC) ≥1.5 × 10^9 / L; Platelet count (PLT) ≥90 × 10^9 / L; Hemoglobin (Hb) ≥90 g / L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Cardiac ultrasound: Left ventricular ejection fraction (LVEF) ≥55%; 4) 12-leads ECG: The QT interval corrected by Fridericia method (QTcF) is less than 470 msec.
- Voluntarily join the study and sign informed consent, with good compliance and willing to cooperate with follow-up.
Who cannot join
- Stage IV (metastatic) breast cancer;
- Inflammatory breast cancer;
- There have been other malignant tumors in the past;
- Have received anthracycline, cyclophosphamide, or anti-HER2 targeted therapy other than trastuzumab/pertuzumab;
- Have participated in other clinical trials at the same time;
- Have undergone major surgical procedures not related to breast cancer within 4 weeks prior to randomization or have not fully recovered from such surgical procedures;
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- Severe heart disease or discomfort, including but not limited to the following:
- History of diagnosis of heart failure or systolic dysfunction (LVEF <50%); High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate> 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular block; Angina pectoris requiring antianginal medication; Clinically significant heart valve disease; ECG shows transmural myocardial infarction; Poor hypertension control (systolic blood pressure> 180 mmHg and / or diastolic blood pressure> 100 mmHg);
- Inability to swallow, intestinal obstruction, or other factors that affect medication administration and absorption;
- People with a known history of allergies to the drugs of this study; a history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- Pregnant and lactating female patients, female patients with fertility with baseline positive pregnancy test, or patients with fertility who are unwilling to use effective contraception during the entire trial and within 7 months after the last medication of study;
- Suffering from a serious concomitant disease or other comorbid condition that interferes with the treatment, or any other condition that the researcher considers unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pyrotinib in Breast Cancer Patients With Poor Response to the Neoadjuvant Treatment of Trastuzumab Combined With Pertuzumab: A Single-center Phase II Clinical Study
Pathological complete remission (pCR) after neoadjuvant therapy in HER2-positive early breast cancer patients is closely related to disease-free survival (DFS) and overall survival (OS), which makes pCR an important evaluation indicator of recurrence risk. Trastuzumab combined with pertuzumab is a new standard targeted treatment regimen for HER2-positive early breast cancer. However, there are still quite a few patients who do not reach PCR. For these patients, current guidelines recommend the use of TDM-1 for intensive treatment after surgery, although a significant number of patients still have recurrence or metastasis. Besides, TDM-1 is unavailable in China. Pyrotinib has been approved for HER2-positive breast cancer patients who have previously failed after the treatment of trastuzumab. The investigators intend to conduct this phase II clinical study. Patients with poor response to the standard neoadjuvant treatment regimen of trastuzumab combined with pertuzumab are enrolled. These patients receive pyrotinib to observe that whether pCR has been improved. The investigators aim to explore the effect of pyrotinib in patients with poor response to standard dual-target neoadjuvant therapy, and further explore the improvement of neoadjuvant treatment strategy in HER2 positive early stage breast cancer patients.
Read the detailed description
Breast cancer is the most common malignant tumor in Chinese women, with 20% to 30% HER2 overexpression. Pathological complete remission (pCR) after neoadjuvant therapy in HER2-positive early stage breast cancer patients is closely related to disease-free survival (DFS) and overall survival (OS), which makes pCR an important evaluation indicator of recurrence risk. Trastuzumab combined with pertuzumab is a new standard targeted treatment regimen for HER2-positive early breast cancer, with overall pCR rate of 57% to 66%. However, there are still quite a few patients who do not reach PCR after treatment in clinical practice. For patients who do not reach pCR with neoadjuvant therapy, current guidelines recommend the use of TDM-1 for intensive treatment after surgery, but even with TDM-1, a significant number of patients still have recurrence or metastasis. Besides, TDM-1 is currently unavailable in China. Pyrotinib has been approved for HER2-positive breast cancer patients who have previously failed after the treatment of trastuzumab. The investigators intend to conduct this single-arm, single-center phase II clinical study. Patients with poor response to the standard neoadjuvant treatment regimen of trastuzumab combined with pertuzumab are enrolled. These patients receive pyrotinib to observe that whether pCR has been improved after the replacement of targeted treatment regimen. The investigators aim to explore the effect of pyrotinib in patients with poor response to standard dual-target neoadjuvant therapy, and further explore the improvement of neoadjuvant treatment strategy in HER2 positive early stage breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Pyrotinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
Also called epirubicin, cyclophosphamide
Pyrotinib is administered orally at 400 mg daily from day 1 of the first cycle to day 21 of the fourth cycle or to the day of surgery, within 30 minutes after breakfast.
Epirubicin (90 mg/m2), intravenously, every 21 days. Cyclophosphamide (600 mg/m2), intravenously, every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib | Experimental | Eligible patients will receive four cycles of epirubicin and cyclophosphamide combined with pyrotinib.
Pyrotinib is administered orally at 400 mg daily from day 1 of the first cycle to day 21 of the fourth cycle or to the day of surgery, within 30 minutes after breakfast.
Epirubicin (90 mg/m2), intravenously, every 21 days. Cyclophosphamide (600 mg/m2), intravenously, every 21 days. Receives: Drug: Pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
tpCR
the absence of invasive neoplastic cells at microscopic examination of the primary tumor and no pathological involvement of ipsilateral axillary lymph nodes at surgery
Measured: 1 year
Secondary outcomes (6)
Objective response rate (ORR)
Defined as the proportion of best overall response of either complete or partial response.
Measured: 1 year
Disease free survival (DFS)
Defined as the time from the date of surgery to the date of recurrence/metastasis or the date of death.
Measured: 5 years
3-year rate of disease-free survival
Defined as rate of 3-year disease-free survival
Measured: 3 years
Event-free survival (EFS)
Defined as the time from the date of surgery to the date of recurrence/metastasis.
Measured: 5 years
Number of Participants with Adverse Events
Defined as number of participants with adverse events related to the treatment
Measured: 1 year
The quality of life
Using EORTC (European Organization for Research and Treatment of Cancer) QLQ-BR23 scale. The minimum and maximum values are 0 and 100, respectively. Higher scores mean better outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Feb 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu fei, Sun Yat-sen University
- Investigators
- Fei Xu, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255056
- Sponsor's protocol ID
- SYSU-CSCO-2020
- Acronym
- PRETTY
- Status last verified
- Feb 2020
- First submitted
- 2 Feb 2020
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- 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 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pyrotinib in Breast Cancer Patients With Poor Response to the Neoadjuvant Treatment of Trastuzumab Combined With Pertuzumab: A Single-center Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT04255056
- Acronym / sponsor ID
- PRETTY / SYSU-CSCO-2020
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 5 Feb 2020 (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.
Pathological complete remission (pCR) after neoadjuvant therapy in HER2-positive early breast cancer patients is closely related to disease-free survival (DFS) and overall survival (OS), which makes pCR an important evaluation indicator of recurrence risk. Trastuzumab combined with pertuzumab is a new standard targeted treatment regimen for HER2-positive early breast cancer. However, there are still quite a few patients who do not reach PCR. For these patients, current guidelines recommend the use of TDM-1 for intensive treatment after surgery, although a significant number of patients still have recurrence or metastasis. Besides, TDM-1 is unavailable in China. Pyrotinib has been approved for HER2-positive breast cancer patients who have previously failed after the treatment of trastuzumab. The investigators intend to conduct this phase II clinical study. Patients with poor response to the standard neoadjuvant treatment regimen of trastuzumab combined with pertuzumab are enrolled. These patients receive pyrotinib to observe that whether pCR has been improved. The investigators aim to explore the effect of pyrotinib in patients with poor response to standard dual-target neoadjuvant therapy, and further explore the improvement of neoadjuvant treatment strategy in HER2 positive early stage breast cancer patients.
Detailed description
Breast cancer is the most common malignant tumor in Chinese women, with 20% to 30% HER2 overexpression. Pathological complete remission (pCR) after neoadjuvant therapy in HER2-positive early stage breast cancer patients is closely related to disease-free survival (DFS) and overall survival (OS), which makes pCR an important evaluation indicator of recurrence risk. Trastuzumab combined with pertuzumab is a new standard targeted treatment regimen for HER2-positive early breast cancer, with overall pCR rate of 57% to 66%. However, there are still quite a few patients who do not reach PCR after treatment in clinical practice. For patients who do not reach pCR with neoadjuvant therapy, current guidelines recommend the use of TDM-1 for intensive treatment after surgery, but even with TDM-1, a significant number of patients still have recurrence or metastasis. Besides, TDM-1 is currently unavailable in China. Pyrotinib has been approved for HER2-positive breast cancer patients who have previously failed after the treatment of trastuzumab. The investigators intend to conduct this single-arm, single-center phase II clinical study. Patients with poor response to the standard neoadjuvant treatment regimen of trastuzumab combined with pertuzumab are enrolled. These patients receive pyrotinib to observe that whether pCR has been improved after the replacement of targeted treatment regimen. The investigators aim to explore the effect of pyrotinib in patients with poor response to standard dual-target neoadjuvant therapy, and further explore the improvement of neoadjuvant treatment strategy in HER2 positive early stage breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib | Experimental | Drug: PyrotinibEligible patients will receive four cycles of epirubicin and cyclophosphamide combined with pyrotinib. Pyrotinib is administered orally at 400 mg daily from day 1 of the first cycle to day 21 of the fourth cycle or to the day of surgery, within 30 minutes after breakfast. Epirubicin (90 mg/m2), intravenously, every 21 days. Cyclophosphamide (600 mg/m2), intravenously, every 21 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients aged ≥ 18 years and ≤ 75 years;
- ECOG score 0-1;
- HER2-overexpressing breast cancer confirmed by immunohistochemical (IHC) analysis or in situ hybridization (ISH).
- The patient has received at least 3 cycles of neoadjuvant therapy with trastuzumab combined with pertuzumab and the clinical response is SD or PD (according to RECIST version 1.1) evaluated with breast MRI/CT/ultrasound.
- Known hormone receptor status (ER and PgR);
Key exclusion criteria (12 listed)
- Stage IV (metastatic) breast cancer;
- Inflammatory breast cancer;
- There have been other malignant tumors in the past;
- Have received anthracycline, cyclophosphamide, or anti-HER2 targeted therapy other than trastuzumab/pertuzumab;
- Have participated in other clinical trials at the same time;
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: epirubicin, cyclophosphamidePyrotinib is administered orally at 400 mg daily from day 1 of the first cycle to day 21 of the fourth cycle or to the day of surgery, within 30 minutes after breakfast. Epirubicin (90 mg/m2), intravenously, every 21 days. Cyclophosphamide (600 mg/m2), intravenously, every 21 days. | Drug | Pyrotinib |
Primary outcome
tpCR
Time frame: 1 year
the absence of invasive neoplastic cells at microscopic examination of the primary tumor and no pathological involvement of ipsilateral axillary lymph nodes at surgery
6 secondary outcomes
Objective response rate (ORR)
Time frame: 1 year
Disease free survival (DFS)
Time frame: 5 years
3-year rate of disease-free survival
Time frame: 3 years
Event-free survival (EFS)
Time frame: 5 years
Number of Participants with Adverse Events
Time frame: 1 year
The quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- 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.
Fei Xu, MD principal investigator
Sun Yat-sen University
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 in people with Breast Cancer, run by Sun Yat-sen University 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 7 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 7 Feb 2020. 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 Fei Xu, MD (+86-13711277870, xufei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tpCR (time frame: 1 year). 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 7 Feb 2020.