Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University

About this trial

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 criteria

Qualifiers

Women aged 18-70;

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);

The pathological type of immunohistochemistry needs to meet the following conditions: HER-2 (3+) or HER-2 (0-2+) but amplified by FISH detection.

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%.

Disqualifiers

The maximum size of the infiltrate is more than 1mm in diameter or the axillary lymph node is positive

HER2 negative: immunohistochemical HER2-,+; Immunohistochemical HER2+ while FISH has no amplification;

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

History of other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;

Trial design

Treatments tested in this trial

  • Capecitabine,Pyrotinib

Treatment groups

1,008 Participants
are divided into 2 treatment groups

Sponsors and collaborators