Breast CancerPhase 2NCT04917900
Single-arm, Multi-center Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin-bound Paclitaxel and Trastuzumab in Neoadjuvant Treatment of Her2-positive Early or Locally Advanced Breast Cancer
A Phase 2 study testing Pyrotinib combined with albumin-bound paclitaxel and trastuzumab in people with Breast Cancer, run by West China Hospital at 1 site in China.
Trial summary
This study aimed to evaluate the Pyrotinib in combination with albumin-bound paclitaxel and trastuzumab to neoadjuvant therapy efficacy and safety of Her2-positive early or locally advanced breast cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pyrotinib combined with albumin-bound paclitaxel and trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 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
- Female patients aged 18 to 70 who were newly treated.
- ECOG systemic state 0~1.
- According to the RECIST 1.1 , at least one measurable lesion exists.
- Patients with HER2-positive breast cancer confirmed by pathological examination, clinical stage II-III [cT2 and any N, cT3 and any N; cT4 and any N, according to American Joint Committee on Cancer (AJCC) standards] Note: HER2 positive means that the result of the pathology department of the participating center hospital is positive, which is defined as the immunohistochemistry (IHC) test result is 3+ or the in situ hybridization (ISH) result is HER2 gene amplification (HER2/CEP17≥2.0 or Average HER2 copy number/cell ≥6).
- The functional level of organs must meet the following requirements: 1) Blood routine: ANC≥1.5×109/L; PLT≥90×109/L; Hb≥90 g/L; 2) Blood biochemistry: TBIL≤1.5×ULN; ALT and AST≤2×ULN; BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); 3) Heart color Doppler ultrasound: LVEF≥50%; 4) 12-lead ECG: Fridericia corrected QT interval (QTcF) female <470 ms.
- The hormone receptor status is known.
- The serum pregnancy test is negative and patients with reproductive potential must agree to use effective non-hormonal contraceptive methods during treatment and at least 6 months after the last use of the test drug.
- Volunteer to join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Who cannot join
- Patients with inflammatory breast cancer.
- Patients with metastatic breast cancer (stage IV).
- Inability to swallow, chronic diarrhea and intestinal obstruction, as well as other factors that affect the administration and absorption of the drug.
- At the same time receive anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy.
- Have received major surgery not related to breast cancer within 4 weeks before enrollment, or have not fully recovered from the surgery.
- Previously used or currently using anti-HER2 targeted drugs (including trastuzumab, pertuzumab, lapatinib, neratinib and pirotinib, etc.).
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- Suffered from other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma.
- Accept any other anti-tumor therapy at the same time.
- Those who are known to have a history of allergies to the drug components of this program; have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
- Previously suffering from heart diseases, including: (1) angina pectoris; (2) arrhythmia requiring medication or clinical significance; (3) myocardial infarction; (4) heart failure; (5) judged by the investigator other heart diseases that are not suitable for participating in this trial.
- Female patients during pregnancy and lactation;The pregnancy test is positive;Female patients of childbearing age who are unwilling to take effective contraceptive measures during the trial.
- According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.).
- Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.
- Concomitant use of CYP3A4 inhibitors or inducers.
- The investigator judges that it is not suitable to participate in any other situations in this research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Chengdu, Sichuan, China, 610041
Ting Luo, MD, +8618602866299, tina621@163.com
Xiaorong zhong, MD, +8618980605984, zhongxiaorong@126.com
About this study
This study aimed to evaluate the Pyrotinib in combination with albumin-bound paclitaxel and trastuzumab to neoadjuvant therapy efficacy and safety of Her2-positive early or locally advanced breast cancer
Read the detailed description
Subjects who met the criteria for admission were treated with pyrotinib combined with albumin-bound paclitaxel and trastuzumab (q3w) neoadjuvant therapy for 6 cycles before surgery, and DCR and ORR were assessed before surgery.All subjects who are suitable for surgery undergo surgery and evaluate their pCR rate (pathological complete remission rate).After the operation, the subjects received adjuvant chemotherapy of epirubicin hydrochloride + cyclophosphamide (q3w) for 4 cycles, and at the same time, according to the researcher's recommendation, they chose the follow-up anti-HER2 treatment plan: it is recommended that subjects who have achieved pCR receive preoperative the same anti-Her2 treatment for 1 year; for non-pCR subjects, T-DM1 or trastuzumab and Pertuzumab can be used for anti-her2 treatment for 1 year.For subjects whose estrogen receptor (ER) and/or progesterone receptor (PR) are positive, endocrine therapy can be started at the end of adjuvant chemotherapy.If there are clinical indications at the end of adjuvant chemotherapy, radiotherapy can be given.
- Conditions
- Breast Cancer
- Being tested
- Pyrotinib combined with albumin-bound paclitaxel and trastuzumab
- Keywords
- Her2-positve Breast Cancer, Neoadjuvant Therapy, 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.
Pyrotinib combined with albumin-bound paclitaxel and trastuzumabDrug
Pyrotinib: 400mg, po,qd,with warm water within 30 minutes after breakfast, q3weeks, 6 cycles in total. Albumin-bound paclitaxel: 260mg/m2, iv, Day1, q3weeks, 6 cycles in total. Trastuzumab: The first cycle dose is 8mg/kg, and each subsequent cycle is 6mg/kg, iv, Day 1, q3weeks, a total of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib combined with albumin-bound paclitaxel and trastuzumab | Experimental | Pyrotinib: 400mg, po,qd,with warm water within 30 minutes after breakfast, q3weeks, 6 cycles in total. Albumin-bound paclitaxel: 260mg/m2, iv, Day1, q3weeks, 6 cycles in total. Trastuzumab: The first cycle dose is 8mg/kg, and each subsequent cycle is 6mg/kg, iv, Day 1, q3weeks, a total of 6 cycles. Receives: Drug: Pyrotinib combined with albumin-bound paclitaxel and trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR) (ypT0/is N0)
No microscopically detectable remnants of aggressive tumors in breast and axillary lymph nodes, ductal carcinoma in situ is allowed
Measured: Estimated up to 2.5 year
Secondary outcomes (4)
Objective response rate (ORR)
The percentage of subjects with CR or PR as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of preoperative neoadjuvant therapy 【(CR+PR)/Analysis of the total number of people】.The solid tumor response assessment standard (RECIST 1.1 standard) was used to assess the objective tumor response.
Measured: Estimated up to 2.5 year
Disease Control Rate (DCR)
The percentage of patients with complete remission (CR), partial remission (PR) and stable disease (SD) (≥4 weeks) confirmed by the RECIST 1.1 standard among patients with evaluable efficacy.
Measured: Estimated up to 2.5 year
Complete remission rate of breast pathology (bpCR）
No microscopically detectable remnants of aggressive tumors in breast, ductal carcinoma in situ is allowed
Measured: Estimated up to 2.5 year
Adverse events (AEs) [ Time Frame: From screening phase until AEs returns to Grade 0-1 or baseline ]
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
In general, AEs are graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE.
The type, grade and frequency of AEs will be reported.
Measured: Estimated up to 2.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Dec 2020
- Primary completion30 Aug 2023 (estimated)
- Study completion31 Dec 2023 (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 West China 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuangyue Liu, West China Hospital
- Investigators
- Ting Luo, post-doctor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917900
- Sponsor's protocol ID
- OBU-SC-BB-BC-II-010
- Status last verified
- Oct 2022
- First submitted
- 2 Jun 2021
- Last updated
- 10 Oct 2022
- 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 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Multi-center Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin-bound Paclitaxel and Trastuzumab in Neoadjuvant Treatment of Her2-positive Early or Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT04917900
- Acronym / sponsor ID
- OBU-SC-BB-BC-II-010
- Conditions
- Breast Cancer
- Keywords
- Her2-positve Breast Cancer, Neoadjuvant Therapy, Pyrotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Jun 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.
This study aimed to evaluate the Pyrotinib in combination with albumin-bound paclitaxel and trastuzumab to neoadjuvant therapy efficacy and safety of Her2-positive early or locally advanced breast cancer
Detailed description
Subjects who met the criteria for admission were treated with pyrotinib combined with albumin-bound paclitaxel and trastuzumab (q3w) neoadjuvant therapy for 6 cycles before surgery, and DCR and ORR were assessed before surgery.All subjects who are suitable for surgery undergo surgery and evaluate their pCR rate (pathological complete remission rate).After the operation, the subjects received adjuvant chemotherapy of epirubicin hydrochloride + cyclophosphamide (q3w) for 4 cycles, and at the same time, according to the researcher's recommendation, they chose the follow-up anti-HER2 treatment plan: it is recommended that subjects who have achieved pCR receive preoperative the same anti-Her2 treatment for 1 year; for non-pCR subjects, T-DM1 or trastuzumab and Pertuzumab can be used for anti-her2 treatment for 1 year.For subjects whose estrogen receptor (ER) and/or progesterone receptor (PR) are positive, endocrine therapy can be started at the end of adjuvant chemotherapy.If there are clinical indications at the end of adjuvant chemotherapy, radiotherapy can be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib combined with albumin-bound paclitaxel and trastuzumab | Experimental | Drug: Pyrotinib combined with albumin-bound paclitaxel and trastuzumabPyrotinib: 400mg, po,qd,with warm water within 30 minutes after breakfast, q3weeks, 6 cycles in total. Albumin-bound paclitaxel: 260mg/m2, iv, Day1, q3weeks, 6 cycles in total. Trastuzumab: The first cycle dose is 8mg/kg, and each subsequent cycle is 6mg/kg, iv, Day 1, q3weeks, a total of 6 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients aged 18 to 70 who were newly treated.
- ECOG systemic state 0~1.
- According to the RECIST 1.1 , at least one measurable lesion exists.
- Patients with HER2-positive breast cancer confirmed by pathological examination, clinical stage II-III [cT2 and any N, cT3 and any N; cT4 and any N, according to American Joint Committee on Cancer (AJCC) standards] Note: HER2 positive means that the result of the pathology department of the participating center hospital is positive, which is defined as the immunohistochemistry (IHC) test result is 3+ or the in situ hybridization (ISH) result is HER2 gene amplification (HER2/CEP17≥2.0 or Average HER2 copy number/cell ≥6).
- The functional level of organs must meet the following requirements: 1) Blood routine: ANC≥1.5×109/L; PLT≥90×109/L; Hb≥90 g/L; 2) Blood biochemistry: TBIL≤1.5×ULN; ALT and AST≤2×ULN; BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); 3) Heart color Doppler ultrasound: LVEF≥50%; 4) 12-lead ECG: Fridericia corrected QT interval (QTcF) female <470 ms.
Key exclusion criteria (15 listed)
- Patients with inflammatory breast cancer.
- Patients with metastatic breast cancer (stage IV).
- Inability to swallow, chronic diarrhea and intestinal obstruction, as well as other factors that affect the administration and absorption of the drug.
- At the same time receive anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy.
- Have received major surgery not related to breast cancer within 4 weeks before enrollment, or have not fully recovered from the surgery.
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 |
|---|---|---|
| Pyrotinib combined with albumin-bound paclitaxel and trastuzumabPyrotinib: 400mg, po,qd,with warm water within 30 minutes after breakfast, q3weeks, 6 cycles in total. Albumin-bound paclitaxel: 260mg/m2, iv, Day1, q3weeks, 6 cycles in total. Trastuzumab: The first cycle dose is 8mg/kg, and each subsequent cycle is 6mg/kg, iv, Day 1, q3weeks, a total of 6 cycles. | Drug | Pyrotinib combined with albumin-bound paclitaxel and trastuzumab |
Primary outcome
Pathological complete response rate (pCR) (ypT0/is N0)
Time frame: Estimated up to 2.5 year
No microscopically detectable remnants of aggressive tumors in breast and axillary lymph nodes, ductal carcinoma in situ is allowed
4 secondary outcomes
Objective response rate (ORR)
Time frame: Estimated up to 2.5 year
Disease Control Rate (DCR)
Time frame: Estimated up to 2.5 year
Complete remission rate of breast pathology (bpCR）
Time frame: Estimated up to 2.5 year
Adverse events (AEs) [ Time Frame: From screening phase until AEs returns to Grade 0-1 or baseline ]
Time frame: Estimated up to 2.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- 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.
Ting Luo, post-doctor principal investigator
West China 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 combined with albumin-bound paclitaxel and trastuzumab in people with Breast Cancer, run by West China 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 15 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 10 Oct 2022. 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 Ting Luo, post-doctor (18602866299, tina621@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) (ypT0/is N0) (time frame: Estimated up to 2.5 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 10 Oct 2022.