Active — Not RecruitingPhase 3

Treatment of Breast Cancer With Trastuzumab + HS627/ Pertuzumab + Docetaxel

China408 participantsStarted 2020-06-28

Plain-language summary

The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks).

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of participants achieving Pathological Complete Response (pCR) as Assessed by the Independent Review Committee (IRC)

Timeframe: After surgery (At surgery cycle 4 Days 22-35)(1 cycle = 21 days)

Trial details

NCT IDNCT04514419

SponsorBioRay Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-11

View on ClinicalTrials.gov More Breast Cancer trials