Breast Cancer Invasive Clinical Trial
Official title:
A Randomised, Multicenter, Open-label, Phase II Study Evaluating Pyrotinib Plus Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in Early Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2 - Positive Breast Cancer
Verified date | March 2022 |
Source | Shanghai Jiao Tong University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.
Status | Active, not recruiting |
Enrollment | 216 |
Est. completion date | December 30, 2027 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - With signed consent - Histologically confirmed invasive breast carcinoma with a primary tumor size of no less than (=) 2 centimeters (cm) by standard local assessment technique - Breast cancer stage at presentation: stage II-III - HER2-positive breast cancer defined as 3+ score by immunohistochemistry in > 10 percent (%) of immunoreactive cells or HER2 gene amplification by in situ hybridization - Known hormone receptor status (estrogen receptor and/or progesterone receptor) - Eastern Cooperative Oncology Group Performance Status equal to or less than (<=) 1 - Baseline left ventricular ejection fracture >= 50% measured by echocardiography - Willing to use highly effective form of nonhormonal contraception while on study and for 7 months after end of study treatment for female with fertility or male - Willing to obey the study protocol Exclusion Criteria: - Stage IV disease - Previous anti-cancer therapy or radiotherapy for any malignancy - History of other malignancy within 5 years prior to screening, except for appropriately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ,Stage I uterine cancer or thyroid papillary microcarcinoma - Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy - Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the participant has not fully recovered - Serious cardiac illness or medical condition - Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness - Any abnormalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization - Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol - Not able to swallow the drug - Pregnant or lactating - Positive serum or urine pregnancy test or above mentioned tests cannot be achieved for women with fertility |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine | Jiangsu HengRui Medicine Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Percentage of Participants With At Least One Adverse Event During Treatment Period | The percentage of participants who experienced at least one adverse event during the neoadjuvant period, surgery, adjuvant treatment period. | From randomization to 30 days after completion of study treatment | |
Primary | Percentage of Participants With Total Pathologic Complete Response (tpCR) | tpCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer [AJCC] staging system).The duration of one treatment cycle is 21 days. | After completion of 4 cycles of neoadjuvant therapy. The duration of one treatment cycle is 21 days | |
Secondary | Percentage of Participants With Breast Pathologic Complete Response (bpCR) | bpCR is defined as the absence of any residual invasive cancer on the hematoxylin and eosin evaluation of the resected breast specimen after completion of neoadjuvant therapy and surgery (that is, ypT0/is, in accordance with current AJCC staging system).The duration of one treatment cycle is 21 days. | After completion of 4 cycles of neoadjuvant therapy The duration of one treatment cycle is 21 days. at the time of surgery | |
Secondary | Clinical response | Percentage of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease During Cycles 1-4, According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. The duration of one treatment cycle is 21 days. | Cycle 1-4. The duration of one treatment cycle is 21 days. | |
Secondary | Event-free survival (EFS) | EFS is defined as the time from randomization to the first documentation of one of the following events: Disease progression (before surgery) as determined by the investigator with use of RECIST v1.1 Any evidence of contralateral disease in situ was not identified as progressive disease; Disease recurrence (local, regional, distant, or contralateral) after surgery; Death from any cause. | From Baseline to EFS event or date last known to be alive and event-free (up to 5 years) | |
Secondary | Disease-free survival (DFS) | DFS was defined as the time from first date of no disease (i.e., date of surgery) to first documentation of one of the following events: Disease recurrence (local, regional, distant, or contralateral) after surgery. Any evidence of contralateral disease in situ was not identified as disease recurrence; Death from any cause. | From surgery to DFS event or date last known to be alive and event-free (up to 5 years) | |
Secondary | Overall survival (OS) | OS was defined as the time from randomization to death from any cause. | From Baseline to OS event or date last known to be alive (up to 5 years) |
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