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Trial Title:
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
NCT ID:
NCT05861271
Condition:
Breast Cancer Stage I
Conditions: Official terms:
Breast Neoplasms
Capecitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Capecitabine，Pyrotinib
Description:
Pyrotinib and Capecitabine for half a year
Arm group label:
Arm-1
Other name:
Pyrotinib
Summary:
For patients with HER2-positive early-stage breast cancer, NCCN guidelines recommend
chemotherapy plus targeted therapy as the standard adjuvant treatment for patients with
tumors larger than 1 cm or lymph node-positive. The APT study enrolled patients with
stage I HER2-positive breast cancer and has confirmed the efficacy and safety of
intravenous chemotherapy combined with targeted therapy, but only 2.2% of the patients
enrolled in microinvasion are enrolled, and there is a lack of large sample size data to
provide a treatment reference for these patients. In order to further explore the optimal
strategy for adjuvant therapy in this type of patient, we designed a new clinical trial
to evaluate the efficacy and safety of oral capecitabine plus pyrotinib as adjuvant
therapy in previous retrospective studies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Women aged 18-70;
2. The pathology of early breast cancer after surgery is T1micN0: histologically
confirmed that the longest diameter of invasive cancer does not exceed 1mm or the
maximum diameter of multiple invasive lesions is less than 1mm, and the lymph node
is negative (N0);
3. The pathological type of immunohistochemistry needs to meet the following
conditions: HER-2 (3+) or HER-2 (0-2+) but amplified by FISH detection.
4. Hormone receptor negative (HR-) is defined as ER, PR expression is <1%; Hormone
receptor positivity (HR+) is defined as ER and/or PR expression ≥1%.
5. For patients with both invasive lesions, if both lesions are HER-2 positive, they
can be enrolled.
6. ECOG score≦ 1 point;
7. No obvious dysfunction of major organs;
8. Blood routine: ANC ≥1.5×109/L, PLT≥100×109/L, blood Hb≥ 9 g/dl (no transfusion
within 14 days);
9. Liver function: total bilirubin ≤1.25×ULN; AST and ALT <2.5×ULN;
10. Renal function: creatinine clearance ≥ 50 mL/min, blood creatinine ≤ 1.5 ×ULN;
11. Cardiac function: ECG is generally normal, QTc< 470 ms; LVEF > 50%;
12. contraception during treatment for women of childbearing age;
13. No history of other malignant tumors in the past 5 years;
14. With the consent of the person and signed the informed consent form, or signed by
the patient's legal representative with the authorization of the patient.
15. Can be followed up and good compliance.
Exclusion Criteria:
1. The maximum size of the infiltrate is more than 1mm in diameter or the axillary
lymph node is positive
2. HER2 negative: immunohistochemical HER2-,+; Immunohistochemical HER2+ while FISH has
no amplification;
3. Patients who have received neoadjuvant therapy or any other form of systemic therapy
or local therapy other than surgery, including chemotherapy, targeted, radiotherapy,
or endocrine therapy, prior to enrollment
4. History of other malignant tumors, except cured basal cell carcinoma of the skin and
carcinoma in situ of the cervix;
5. Metastasis of any part;
6. Pregnant or lactating women, women of childbearing age who cannot be effectively
contraceptives;
7. Patients who participate in other clinical trials at the same time;
8. Severe organ function (heart, lung, liver and kidney) insufficiency, LEVF < 50%
(ultracardiogram); severe cardiovascular and cerebrovascular diseases (such as:
unstable angina, chronic heart failure, uncontrollable hypertension >150/90mmgh,
myocardial infarction or cerebrovascular accident) within 6 months before
enrollment; diabetics with poor glycemic control; Patients with severe hypertension;
9. Severe or uncontrolled infection;
10. Those who have a history of psychotropic substance abuse and cannot quit or have a
history of mental disorders;
11. Patients who are judged by the investigator to be unsuitable to participate in this
study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast cancer institute of Fudan University Cancer Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi-Ming Shao, MD
Phone:
86-21-641755901105
Email:
zhimingshao@yahoo.com
Contact backup:
Last name:
Ruoxi Wang, MD
Phone:
86-21-641755901105
Email:
08301010259@fudan.edu.cn
Investigator:
Last name:
Zhi-Ming Shao, MD
Email:
Principal Investigator
Investigator:
Last name:
Ruoxi Wang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ying Zhou
Email:
Sub-Investigator
Start date:
June 1, 2023
Completion date:
July 1, 2028
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05861271
