Clinical Trials in China / NCT04514419
Active, not recruiting
Phase 3
Treatment of Breast Cancer With Trastuzumab + HS627/ Pertuzumab + Docetaxel
NCT04514419 · tracked via the Priya Life Science China tracker
Condition(s) studied
Breast Cancer
Investigational drug(s) / intervention(s)
HS627: Prior to surgery: trastuzumab, HS627, and docetaxel for 4 cycles (1 cycle = 21 days).
Pertuzumab: Prior to surgery: trastuzumab, Pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days).
Study summary
The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks).
Eligibility
Inclusion Criteria:
* Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (\>) 2 centimeters (cm) by standard local assessment technique;
* Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0), locally advanced (T2-3, N2-3,M0 or T4a-c, any N, M0), or infl ammatory (T4d, any N,M0);
* Known hormone receptor status (estrogen receptor and/or progesterone receptor);
* HER2 positive (HER2+++ by IHC or ISH+).
* Baseline left ventricular ejection fracture \>= 55% measured by echocardiography (preferred) or multiple gated acquisition scan;
* Normalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization;
* Absolute value of neutrophils ≥ 1.5 × 109 / L;
* Platelet ≥ 90×109 / L;
* Hemoglobin ≥ 90g / L;
* Serum creatinine≤ 1.5 times the upper limit of normal (ULN);
* Serum total bilirubin≤1.5 times ULN (except for Gilbert syndrome);
* Aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT) ≤ 1.5-fold ULN;
* International normalized ratio (INR), activated partial prothrombin time (APTT) ≤ 1.5 times ULN.
* ECOG≤1;
Exclusion Criteria:
* Stage IV metastatic ;
* Bilateral breast cancer;
* Previous anti-cancer therapy or radiotherapy for any malignancy;
* History of other malignancy within 5 years, except for appropriately-treated carcinoma in Cervical carcinoma in situ, basal cell carcinoma or squamous cell skin cancer;
* Serious cardiac illness or medical condition;
* HIV antibody positive; HCV antibody positive and HCV RNA positive; HBcAb or HBsAg positive, and HBV DNA positive;
* Sensitivity to any of the study medications, any of the ingredients or excipients of these medications;
* Known mental history had poor compliance;
* Known to have drug abusers;
* Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy;
* Needed intravenous antibiotic treatment due to infection within 7 days before random enrollment;
* Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or expected to perform major surgery during the trial period;
* Premenopausal women (menopause is defined as non treatment induced menopause≥12 months) or without surgical sterilization (e.g., ovariectomy and / or uterus): refuse to take one or more effective contraceptive measures during treatment and at least 6 months after the last study treatment; blood pregnancy test is positive; pregnant or lactating women; Considered unsuitable for the study or may not be able to complete the trial due to other reasons.
Primary outcome measure(s)
- Percentage of participants achieving Pathological Complete Response (pCR) as Assessed by the Independent Review Committee (IRC) — After surgery (At surgery cycle 4 Days 22-35)(1 cycle = 21 days)
pCR was defined as ypT0/is According to the American Joint Committee on Cancer Staging System as Assessed by the IRC
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04514419 on ClinicalTrials.gov ↗ ← All trials in China