Preoperative Treatment of HR+/HER2+Breast Cancer With Pirotinib, Trastuzumab and AI Research

NCT05885776 | Unknown Phase 2 DMC

• 1 other identifier: Tianjin Cancer Hospital
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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。

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  18weeks

Secondary Outcomes (1)

• Follow up on postoperative pathological reports for evaluation for Optimal overall response rate (BORR)

  18weeks

Other Outcomes (2)

• Follow up on postoperative pathological reports for evaluation for tumor residual load(RCB)

  18weeks

• Follow up on postoperative pathological reports for evaluation for breast retention rate

  18weeks

Study Arms (1)

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

Drug: Pyrrolidine、trastuzumab、AI

Interventions

Pyrrolidine、trastuzumab、AI DRUG

Subjects who met the inclusion criteria underwent surgery after 6 cycles of treatment with pirotinib+trastuzumab+AI, and their postoperative pathological remission was evaluated.

Also known as: OFS (OFS includes bilateral eggs Nest removal or GnRHa drugs)

Targeted combined endocrine therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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%
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• JIE GE, doctor

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xuejing liu, postgraduate

CONTACT

18722010265; lxj8109@126.com

xuwei fu, postgraduate

CONTACT

18503299850; lxj8109@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: June 2, 2023
• Study Start: September 13, 2022
• Primary Completion: March 30, 2024
• Study Completion: September 30, 2025
• Last Updated: June 2, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: March 30, 2025
• Access Criteria: Medical scholars in the world

Locations

CN (1)