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Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

NCT05861271•Fudan University

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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

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;
+5 more criteria

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;
+1 more criteria

Locations (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

June 1, 2023

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2028

Last Updated

March 22, 2024

Enrollment

1,008

ESTIMATED participants

Conditions

Breast Cancer Stage I

Interventions

Capecitabine，Pyrotinib

DRUG

Contacts

Zhimin Shao, MD

CONTACT

+86-021-64175590 zhimingshao@yahoo.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

Inclusion Criteria

Exclusion Criteria

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