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

NCT04917900 | Unknown Phase 2

• 1 other identifier: OBU-SC-BB-BC-II-010
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer

Keywords

Her2-positve Breast Cancer; Neoadjuvant Therapy; Pyrotinib

Outcome Measures

Primary Outcomes (1)

• 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

  Estimated up to 2.5 year

Secondary Outcomes (4)

• Objective response rate (ORR)

  Estimated up to 2.5 year

• Disease Control Rate (DCR)

  Estimated up to 2.5 year

• Complete remission rate of breast pathology (bpCR）

  Estimated up to 2.5 year

• Adverse events (AEs) [ Time Frame: From screening phase until AEs returns to Grade 0-1 or baseline ]

  Estimated up to 2.5 year

Study Arms (1)

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.

Drug: Pyrotinib combined with albumin-bound paclitaxel and trastuzumab

Interventions

Pyrotinib combined with albumin-bound paclitaxel and trastuzumab DRUG

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.

Pyrotinib combined with albumin-bound paclitaxel and trastuzumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).
• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Chengdu, Sichuan, China, 610041, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel; Trastuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Ting Luo, post-doctor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Luo, post-doctor

CONTACT

18602866299; tina621@163.com

Xiaorong Zhong, post-doctor

CONTACT

18980605984; zhongxiaorong@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: PRINCIPAL INVESTIGATOR
• PI Title: Head and Neck Oncology

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 8, 2021
• Study Start: December 1, 2020
• Primary Completion: August 30, 2023
• Study Completion: December 31, 2023
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)