Breast CancerPhase 3NCT04973319
Trastuzumab Combined With Pertuzumab for Adjuvant Treatment of Breast Cancer After Neoadjuvant Therapy
A Phase 3 study testing Pyrotinib and Trastuzumab in people with Breast Cancer, run by Shengjing Hospital at 1 site in China.
Trial summary
Patients with HER-2 positive breast cancer who have poor outcomes after endocrinotherapy and standard chemotherapy can be significantly improved by the use of anti-HER-2 monoclonal antibody trastuzumab. 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 and Trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 but ≤ 75 years (The maximal age of the subjects enrolled in the Phase 3 study of pyrotinib is 75 years old, and there is no safety data for the use of the drug in older people);
- ECOG level 0-1;
- Primary infiltrating breast lesions and lymph nodes should follow these conditions at the same time: histologically confirmed invasive breast cancer; receiving neoadjuvant treatment and completing the operation, with postoperative pathological examination indicating residual invasive cancer in the breast or axillary lymph nodes; HER2-positive breast cancer is confirmed in the pathology test, with 3+ in immunohistochemistry (IHC) test and HER2 gene amplification (HER2/CEP17 ≥ 2.0 or average HER2 copy number/cell number ≥ 6); no recurrent and metastatic disease after surgery;
- HER-2 positive breast cancer patients who have non-pCR after trastuzumab+pertuzumab as neoadjuvant therapy, and have completed trastuzumab combined with pertuzumab as adjuvant treatment. During the neoadjuvant and/or adjuvant therapy phase, at least ≥24 weeks (8 drug delivery cycles) of trastuzumab + pertuzumab. And the time interval from the end of the last trastuzumab treatment to entering the trial must be ≤ 1 year;
- Hormone receptor status (ER and PR) that is known;
- The functional level of major organs must conform to the following requirements (no blood transfusion, no use of white blood cell- and platelet-increasing drugs within 2 weeks before screening): Neutrophils (ANC) ≥ 1.5×109/L; Platelet count (PLT) ≥ 90×109/L; Hemoglobin (Hb) ≥ 90 g/L; Total bilirubin (TBIL)≤ 1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5×ULN;
- Female patients who are not menopausal or not surgically sterilized agree to abstain from sex or use effective non-hormonal drugs for contraception during the treatment period and within 8 weeks after the last administration;
- Patients who participate in the trial voluntarily, sign an informed consent, have good compliance and are willing to comply with the follow-up visit.
Who cannot join
- With a history of recurrent local or regional breast disease;
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- With a history of any malignancies other than breast cancer in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma;
- Patients who have received pyrotinib, lapatinib, neratinib or other tyrosine kinase inhibitors, enmetrastuzumab (T-DM1), and other anti-tumor biological therapies or tumor immunotherapy;
- Patients who are receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
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- Severe heart disease or discomfort, including but not limited to the following diseases: a confirmed history of heart failure or systolic dysfunction (LVEF < 50%); high-risk uncontrolled arrhythmia, such as atrial tachycardia, remarkable ventricular arrhythmia (such as ventricular tachycardia) or higher-grade atrioventricular block; angina pectoris requiring anti-angina medication; clinically significant valvular disease; transmural myocardial infarction shown by ECG; uncontrolled blood pressure in patients with hypertension who have been given antihypertensive drugs (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg);
- Inability to swallow, intestinal obstruction or other factors that affect drug taking and absorption;
- With a history of diagnosed neurological or mental disorders, including involuntary behavior or mental illness;
- With a history of gastrointestinal diseases with diarrhea as the main symptom;
- Patients who are known to have a history of allergies to the drug components in this trial; have a history of immunodeficiency, including HIV positive results, or other acquired or congenital immunodeficiency diseases; or have a history of organ transplantation;
- Female patients during pregnancy and lactation, or those who are fertile and positive for baseline pregnancy test;
- Serious concomitant diseases or other comorbid diseases that will interfere with the planned treatment, including infectious diseases with active infections (including but not limited to hepatitis B, active hepatitis C, active tuberculosis, active syphilis, etc.); or any other cases in which the investigator believes that the patient cannot participate in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, 110004
Nan Niu, MD, 8618940256668, niunannancy@163.com
Cai-Gang Liu, MD
About this study
Official title: Trastuzumab Combined With Pertuzumab and Sequential Use of Pyrotinib vs. Trastuzumab Combined With Pertuzumab for Adjuvant Treatment of Breast Cancer After Neoadjuvant Therapy
Patients with HER-2 positive breast cancer who have poor outcomes after endocrinotherapy and standard chemotherapy can be significantly improved by the use of anti-HER-2 monoclonal antibody trastuzumab. In the current clinical practice of neoadjuvant therapy, trastuzumab combined with chemotherapy can significantly increase the pCR and improve the outcomes in patients. However, there seems to be no available treatment for patients who have no pCR and still have residual tumors except for sequential trastuzumab treatment for 1 year. Compared with trastuzumab, a HER-2 macromolecule inhibitor, pyrotinib has a different site of action and an increased EGFR target. Compared with lapatinib, a small molecule inhibitor of EGFR and HER-2, pyrotinib is an irreversible inhibitor, with the ability to achieve a better curative effect at a lower human plasma exposure level. This trial is designed to evaluate the effectiveness and safety of trastuzumab combined with pertuzumab followed by sequential pyrotinib treatment in non-pCR patients after neoadjuvant therapy.
Read the detailed description
In recent years, the interest has greatly increased in how to proceed with postoperative intensive adjuvant therapy for early breast cancer patients who have not reached pCR and still have residual lesion after neoadjuvant therapy. Relevant efficacy and safety data have been continuously verified in clinical trials, and some treatments have been clinically approved. Moreover, new attempts and explorations are still going on in clinical practice. Based on the preliminary clinical findings, it is planned to design a randomized controlled, open-label, multi-center phase III clinical study that will explore the efficacy of trastuzumab combined with pertuzumab for 1 year followed by sequential pyrotinib vs. touzumab combined with pertuzumab for 1 year, aiming to verify that dual-target adjuvant therapy with sequential use of pyrotinib maleate tablets is superior to dual-target adjuvant therapy alone in HER-2 positive early breast cancer patients who have not reached pCR after neoadjuvant therapy. If this clinical trial achieves a positive result, the use of pyrotinib maleate tablets will be promoted for early breast cancer patients who have not reached pCR and still have residual tumor lesions after neoadjuvant therapy with an attempt to further achieve improved outcomes and prognosis.
- Conditions
- Breast Cancer
- Being tested
- Pyrotinib, Trastuzumab
- Keywords
- breast cancer; pyrotinib; trastuzumab; pertuzumab
- 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 Trastuzumab and pertuzumab
Each subject in the test group will receive the test drug (pyrotinib) for 52 weeks, and will be followed up for at least 3 years from the start of randomization, until disease recurrence, intolerable toxicity, withdrawal of informed consent, or termination of the medication as per the investigator's judgment.
TrastuzumabDrug
Also called pertuzumab
Each enrolled subject will complete at least ≥ 24 weeks (8 drug delivery cycles) of trastuzumab combined with pertuzumab in the neoadjuvant and/or adjuvant treatment phase.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Each subject in the test group will receive the test drug (pyrotinib) for 52 weeks, and will be followed up for at least 3 years from the start of randomization, until disease recurrence, intolerable toxicity, withdrawal of informed consent, or termination of the medication as per the investigator's judgment. The subject who has a second primary malignant tumor in a non-breast area will continue to be followed up until a recurrent disease or death due to primary breast cancer. The subjects who are hormone receptor-positive will be advised to receive endocrinotherapy simultaneously. Within 28 days after the last administration of the test drug, the subjects in the test group must complete the safety follow-up and the end-of-treatment visit and continue to receive the follow-up visit. Receives: Drug: Pyrotinib |
| control group | Other | Each enrolled subject will complete at least ≥ 24 weeks (8 drug delivery cycles) of trastuzumab combined with pertuzumab in the neoadjuvant and/or adjuvant treatment phase. Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease-Free Survival (IDFS)
the time from the date of randomization to the first appearance of recurrent disease. Recurrent diseases include ipsilateral or contralateral breast cancer, local or regional recurrence, distant recurrence and death from any cause.
Measured: at least 3 years from the beginning of randomization.
Secondary outcomes (3)
Disease-Free Survival (DFS)
the time from the date of randomization to the first occurrence of any recurrent disease. Recurrent diseases include second primary malignant tumor in the non-breast region and preinvasive cancer in the breast duct.
Measured: at least 3 years from the date of randomization
overall survival (OS)
the time from the date of randomization to death due to any cause.
Measured: at least 3 years from the date of randomization
Distant Disease-Free Survival (DDFS)
the time from the date of randomization to the first occurrence of distant recurrence or death from any cause
Measured: at least 3 years from the date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (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 Shengjing HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caigang Liu, Shengjing Hospital
- Investigators
- Cai-Gang Liu, MD, Principal investigator, Department of Breast Surgery, Shengjing Hospital affiliated to China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973319
- Sponsor's protocol ID
- Shengjing-LCG008
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trastuzumab Combined With Pertuzumab and Sequential Use of Pyrotinib vs. Trastuzumab Combined With Pertuzumab for Adjuvant Treatment of Breast Cancer After Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT04973319
- Acronym / sponsor ID
- Shengjing-LCG008
- Conditions
- Breast Cancer
- Keywords
- breast cancer; pyrotinib; trastuzumab; pertuzumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 22 Jul 2021 (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.
Patients with HER-2 positive breast cancer who have poor outcomes after endocrinotherapy and standard chemotherapy can be significantly improved by the use of anti-HER-2 monoclonal antibody trastuzumab. In the current clinical practice of neoadjuvant therapy, trastuzumab combined with chemotherapy can significantly increase the pCR and improve the outcomes in patients. However, there seems to be no available treatment for patients who have no pCR and still have residual tumors except for sequential trastuzumab treatment for 1 year. Compared with trastuzumab, a HER-2 macromolecule inhibitor, pyrotinib has a different site of action and an increased EGFR target. Compared with lapatinib, a small molecule inhibitor of EGFR and HER-2, pyrotinib is an irreversible inhibitor, with the ability to achieve a better curative effect at a lower human plasma exposure level. This trial is designed to evaluate the effectiveness and safety of trastuzumab combined with pertuzumab followed by sequential pyrotinib treatment in non-pCR patients after neoadjuvant therapy.
Detailed description
In recent years, the interest has greatly increased in how to proceed with postoperative intensive adjuvant therapy for early breast cancer patients who have not reached pCR and still have residual lesion after neoadjuvant therapy. Relevant efficacy and safety data have been continuously verified in clinical trials, and some treatments have been clinically approved. Moreover, new attempts and explorations are still going on in clinical practice. Based on the preliminary clinical findings, it is planned to design a randomized controlled, open-label, multi-center phase III clinical study that will explore the efficacy of trastuzumab combined with pertuzumab for 1 year followed by sequential pyrotinib vs. touzumab combined with pertuzumab for 1 year, aiming to verify that dual-target adjuvant therapy with sequential use of pyrotinib maleate tablets is superior to dual-target adjuvant therapy alone in HER-2 positive early breast cancer patients who have not reached pCR after neoadjuvant therapy. If this clinical trial achieves a positive result, the use of pyrotinib maleate tablets will be promoted for early breast cancer patients who have not reached pCR and still have residual tumor lesions after neoadjuvant therapy with an attempt to further achieve improved outcomes and prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Drug: PyrotinibEach subject in the test group will receive the test drug (pyrotinib) for 52 weeks, and will be followed up for at least 3 years from the start of randomization, until disease recurrence, intolerable toxicity, withdrawal of informed consent, or termination of the medication as per the investigator's judgment. The subject who has a second primary malignant tumor in a non-breast area will continue to be followed up until a recurrent disease or death due to primary breast cancer. The subjects who are hormone receptor-positive will be advised to receive endocrinotherapy simultaneously. Within 28 days after the last administration of the test drug, the subjects in the test group must complete the safety follow-up and the end-of-treatment visit and continue to receive the follow-up visit. |
| control group | Other | Drug: TrastuzumabEach enrolled subject will complete at least ≥ 24 weeks (8 drug delivery cycles) of trastuzumab combined with pertuzumab in the neoadjuvant and/or adjuvant treatment phase. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients aged ≥ 18 but ≤ 75 years (The maximal age of the subjects enrolled in the Phase 3 study of pyrotinib is 75 years old, and there is no safety data for the use of the drug in older people);
- ECOG level 0-1;
- Primary infiltrating breast lesions and lymph nodes should follow these conditions at the same time: histologically confirmed invasive breast cancer; receiving neoadjuvant treatment and completing the operation, with postoperative pathological examination indicating residual invasive cancer in the breast or axillary lymph nodes; HER2-positive breast cancer is confirmed in the pathology test, with 3+ in immunohistochemistry (IHC) test and HER2 gene amplification (HER2/CEP17 ≥ 2.0 or average HER2 copy number/cell number ≥ 6); no recurrent and metastatic disease after surgery;
- HER-2 positive breast cancer patients who have non-pCR after trastuzumab+pertuzumab as neoadjuvant therapy, and have completed trastuzumab combined with pertuzumab as adjuvant treatment. During the neoadjuvant and/or adjuvant therapy phase, at least ≥24 weeks (8 drug delivery cycles) of trastuzumab + pertuzumab. And the time interval from the end of the last trastuzumab treatment to entering the trial must be ≤ 1 year;
- Hormone receptor status (ER and PR) that is known;
Key exclusion criteria (13 listed)
- With a history of recurrent local or regional breast disease;
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- With a history of any malignancies other than breast cancer in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma;
- Patients who have received pyrotinib, lapatinib, neratinib or other tyrosine kinase inhibitors, enmetrastuzumab (T-DM1), and other anti-tumor biological therapies or tumor immunotherapy;
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: Trastuzumab and pertuzumabEach subject in the test group will receive the test drug (pyrotinib) for 52 weeks, and will be followed up for at least 3 years from the start of randomization, until disease recurrence, intolerable toxicity, withdrawal of informed consent, or termination of the medication as per the investigator's judgment. | Drug | test group |
| TrastuzumabAlso: pertuzumabEach enrolled subject will complete at least ≥ 24 weeks (8 drug delivery cycles) of trastuzumab combined with pertuzumab in the neoadjuvant and/or adjuvant treatment phase. | Drug | control group |
Primary outcome
Invasive Disease-Free Survival (IDFS)
Time frame: at least 3 years from the beginning of randomization.
the time from the date of randomization to the first appearance of recurrent disease. Recurrent diseases include ipsilateral or contralateral breast cancer, local or regional recurrence, distant recurrence and death from any cause.
3 secondary outcomes
Disease-Free Survival (DFS)
Time frame: at least 3 years from the date of randomization
overall survival (OS)
Time frame: at least 3 years from the date of randomization
Distant Disease-Free Survival (DDFS)
Time frame: at least 3 years from the date of randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- 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.
Cai-Gang Liu, MD principal investigator
Department of Breast Surgery, Shengjing Hospital affiliated to China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pyrotinib and Trastuzumab in people with Breast Cancer, run by Shengjing 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 8 inclusion and 13 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: opening soon, as of the sponsor's last update on 22 Jul 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nan Niu, MD (8618940256668, niunannancy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Disease-Free Survival (IDFS) (time frame: at least 3 years from the beginning of randomization.). 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 22 Jul 2021.