Breast CancerPhase 2PYTHONNCT05885776
Preoperative Treatment of HR+/HER2+Breast Cancer With Pirotinib, Trastuzumab and AI Research
A Phase 2 study testing Pyrrolidine、trastuzumab、AI in people with Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Research topic Preoperative efficacy and safety of pyrrolitinib combined with trastuzumab and AI in the treatment of HR+/HER2+breast cancer Overall: A single arm multicenter phase II exploratory study。Subjects HR+/HER2+breast cancer patients in stage Ⅱ~Ⅲ A。 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?
- Pyrrolidine、trastuzumab、AI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2022to 30 Sep 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 initial treatment patients aged ≥ 18 years and ≤ 75 years old
- ECOG score 0-1
- Stage II-IIIA invasive breast cancer, diameter ≥ 20mm
- HER2 positive (IHC score of 3+, or 2+and ISH test positive)
- ER>10%
- Doctors choose to use letrozole/anastrozole for endocrine therapy
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- The definition of menopause includes any of the following: (Previous bilateral oophorectomy; Age)≥ 60 years old; Age<60 years old and without chemotherapy, tamoxifen, toremifen, or ovarian suppressionUnder normal conditions, menopause lasts for ≥ 12 months, and follicle stimulating hormone (FSH) and estradiol are within the postmenopausal range;If receiving tamoxifen or toremifen and age<60 years, FSH and plasma estradiolWithin the postmenopausal range)
- Left ventricular ejection fraction (LVEF) ≥ 50%
- 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for females<470ms；
- The functional level of the main organs must meet the following requirements: blood routine: ANC ≥ 1.5 × 109/L； PLT≥90 × 109/L； Hb≥90 g/L；Blood biochemistry: TBIL ≤ 2.5 × ULN； ALT and AST ≤ 2.5 × ULN； BUN and Cr ≤ 1.5 × ULN；
- For female subjects who have not undergone menopause or surgical sterilization, during the treatment period and during the study treatment
- Agree to abstain or use effective contraceptive methods for at least 2 months after the next administration; .Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up.
Who cannot join
- Stage IIIB-IV or inflammatory breast cancer
- Metastatic tumor
- Previous or concurrent malignant tumors, whose natural history or treatment may interfere with the safety of the research protocol Patients evaluated for sex or efficacy are not eligible to participate in this trial, but basal or squamous cell skin Except for cancer, cervical cancer in situ or bladder cancer, or the subject has no disease (other cancer) to survive At least 5 years.
- Active infections that require systemic treatment
- Has used any medication in this study within 14 days prior to enrollment
- Major surgery (excluding biopsy) performed within 14 days before enrollment
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- Gastrointestinal dysfunction or diseases may seriously affect the absorption of drugs in this study (such as ulcerative Disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) or Severe damage to the ability to swallow capsules/tablets
- Known history of myelodysplastic syndrome or acute myeloid leukemia
- Have a history of abdominal fistula, gastrointestinal perforation, or abdominal abscess within 28 days
- Have any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months
- Within 6 years, there is a history of acute coronary syndrome (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stent implantation) or symptomatic pericarditis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300000
JIE GE, doctor, 19502151516 ext. 022-23340123, lxj8109@126.com
About this study
Official title: Preoperative Treatment of HR+/HER2+Breast Cancer With Pyrrolitinib Combined With Trastuzumab and AI Efficacy and Safety of: a Single Arm Multicenter Phase II Exploratory Study
Research topic Preoperative efficacy and safety of pyrrolitinib combined with trastuzumab and AI in the treatment of HR+/HER2+breast cancer Overall: A single arm multicenter phase II exploratory study。Subjects HR+/HER2+breast cancer patients in stage Ⅱ~Ⅲ A。
Read the detailed description
Research topic Preoperative efficacy and safety of pyrrolitinib combined with trastuzumab and AI in the treatment of HR+/HER2+breast cancer Overall: A single arm multicenter phase II exploratory study。Subjects HR+/HER2+breast cancer patients in stage Ⅱ~Ⅲ A。Main research purposes: To explore the efficacy and safety of the combination of large and small molecules (pyrrolidine combined with trastuzumab combined with AI) in the preoperative treatment of early HR+/HER2+breast cancer.Secondary study objective: To explore the feasibility of neoadjuvant descending ladder therapy and the changes in ctDNA to provide clues for screening predictive markers.Primary endpoint: Pathological complete response rate (tpCR: ypT0-is/ypN0)。Secondary end points: optimal overall response rate (BORR), bpCR (ypT0-is), tumor residual load (RCB), disease free survival (DFS), breast retention rate, safety。Pyrrolidine (400mg po qd)，Trastuzumab (initial dose 8 mg/kg, follow-up 6 mg/kg ivgtt, d1, Q 3w, total 6 Period)，Anatriazole (1mg po qd)/ Letrozole (2.5mg po qd).For premenopausal or perimenopausal patients, it is necessary to combine OFS (OFS includes bilateral eggs Nest removal or GnRHa drugs).
- Conditions
- Breast Cancer
- Being tested
- Pyrrolidine、trastuzumab、AI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrrolidine、trastuzumab、AIDrug
Also called OFS (OFS includes bilateral eggs Nest removal or GnRHa drugs)
Subjects who met the inclusion criteria underwent surgery after 6 cycles of treatment with pirotinib+trastuzumab+AI, and their postoperative pathological remission was evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Targeted combined endocrine therapy | Experimental | Subjects who met the inclusion criteria underwent surgery after 6 cycles of treatment with pyrrolitinib+trastuzumab+AI, and their pathological remission was evaluated after surgery Receives: Drug: Pyrrolidine、trastuzumab、AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow up on postoperative pathological reports for evaluation for Pathological complete response rate (tpCR: ypT0-is/ypN0)
Follow up on postoperative pathological reports for evaluation rely onMiller\&Payne principles
Measured: 18weeks
Secondary outcomes (1)
Follow up on postoperative pathological reports for evaluation for Optimal overall response rate (BORR)
Follow up on postoperative pathological reports for evaluation rely onMiller\&Payne principles
Measured: 18weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start13 Sep 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Sep 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 Tianjin Medical University Cancer Institute and 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
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JIE GE, doctor, Principal investigator, Tianjin Cancer Hospital Airport Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885776
- Sponsor's protocol ID
- Tianjin Cancer Hospital
- Acronym
- PYTHON
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient baseline information, patient safety information
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Treatment of HR+/HER2+Breast Cancer With Pyrrolitinib Combined With Trastuzumab and AI Efficacy and Safety of: a Single Arm Multicenter Phase II Exploratory Study
- ClinicalTrials.gov ID
- NCT05885776
- Acronym / sponsor ID
- PYTHON / Tianjin Cancer Hospital
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 2 Jun 2023 (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.
Research topic Preoperative efficacy and safety of pyrrolitinib combined with trastuzumab and AI in the treatment of HR+/HER2+breast cancer Overall: A single arm multicenter phase II exploratory study。Subjects HR+/HER2+breast cancer patients in stage Ⅱ~Ⅲ A。
Detailed description
Research topic Preoperative efficacy and safety of pyrrolitinib combined with trastuzumab and AI in the treatment of HR+/HER2+breast cancer Overall: A single arm multicenter phase II exploratory study。Subjects HR+/HER2+breast cancer patients in stage Ⅱ~Ⅲ A。Main research purposes: To explore the efficacy and safety of the combination of large and small molecules (pyrrolidine combined with trastuzumab combined with AI) in the preoperative treatment of early HR+/HER2+breast cancer.Secondary study objective: To explore the feasibility of neoadjuvant descending ladder therapy and the changes in ctDNA to provide clues for screening predictive markers.Primary endpoint: Pathological complete response rate (tpCR: ypT0-is/ypN0)。Secondary end points: optimal overall response rate (BORR), bpCR (ypT0-is), tumor residual load (RCB), disease free survival (DFS), breast retention rate, safety。Pyrrolidine (400mg po qd)，Trastuzumab (initial dose 8 mg/kg, follow-up 6 mg/kg ivgtt, d1, Q 3w, total 6 Period)，Anatriazole (1mg po qd)/ Letrozole (2.5mg po qd).For premenopausal or perimenopausal patients, it is necessary to combine OFS (OFS includes bilateral eggs Nest removal or GnRHa drugs).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted combined endocrine therapy | Experimental | Drug: Pyrrolidine、trastuzumab、AISubjects who met the inclusion criteria underwent surgery after 6 cycles of treatment with pyrrolitinib+trastuzumab+AI, and their pathological remission was evaluated after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female initial treatment patients aged ≥ 18 years and ≤ 75 years old
- ECOG score 0-1
- Stage II-IIIA invasive breast cancer, diameter ≥ 20mm
- HER2 positive (IHC score of 3+, or 2+and ISH test positive)
- ER>10%
Key exclusion criteria (11 listed)
- Stage IIIB-IV or inflammatory breast cancer
- Metastatic tumor
- Previous or concurrent malignant tumors, whose natural history or treatment may interfere with the safety of the research protocol Patients evaluated for sex or efficacy are not eligible to participate in this trial, but basal or squamous cell skin Except for cancer, cervical cancer in situ or bladder cancer, or the subject has no disease (other cancer) to survive At least 5 years.
- Active infections that require systemic treatment
- Has used any medication in this study within 14 days prior to enrollment
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 |
|---|---|---|
| Pyrrolidine、trastuzumab、AIAlso: OFS (OFS includes bilateral eggs Nest removal or GnRHa drugs)Subjects who met the inclusion criteria underwent surgery after 6 cycles of treatment with pirotinib+trastuzumab+AI, and their postoperative pathological remission was evaluated. | Drug | Targeted combined endocrine therapy |
Primary outcome
Follow up on postoperative pathological reports for evaluation for Pathological complete response rate (tpCR: ypT0-is/ypN0)
Time frame: 18weeks
Follow up on postoperative pathological reports for evaluation rely onMiller\&Payne principles
1 secondary outcome
Follow up on postoperative pathological reports for evaluation for Optimal overall response rate (BORR)
Time frame: 18weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: Yes. Patient baseline information, patient safety information
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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.
JIE GE, doctor principal investigator
Tianjin Cancer Hospital Airport 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 Pyrrolidine、trastuzumab、AI in people with Breast Cancer, run by Tianjin Medical University Cancer Institute and 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 12 inclusion and 11 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 2 Jun 2023. 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 xuejing liu, postgraduate (18722010265 ext. 022-23340123, lxj8109@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow up on postoperative pathological reports for evaluation for Pathological complete response rate (tpCR: ypT0-is/ypN0) (time frame: 18weeks). 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 2 Jun 2023.