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Compares treatment options for Breast Cancer
Official title Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer
ClinicalTrials.gov ID: NCT05638594
What this study is testing
What is Pyrotinib?
Pyrotinib is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an investigator-initiated randomized controlled, open-label, multicenter, prospective Phase 2 clinical study. Patients with stage II-III HR +/HER2 + breast cancer were randomly divided into two groups at a ratio of 1:1.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Female patients aged 18 -75 ;
- Willing to receive LHRH agonist therapy (premenopausal patients only);
- All patients were histopathologically confirmed to be estrogen receptor (ER) -positive and HER2-positive.
- Treatment-naïve stage II-III patients with tumor stage meeting AJCC version 8 criteria;
- ECOG score 0-1;
You likely can't join if
- Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- Received any other anti-tumor therapy at the same time;
- Bilateral breast cancer, inflammatory breast cancer or occult breast cancer;
- Stage IV breast cancer;
- Breast cancer without histopathological diagnosis;
- Other malignant tumors in the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;
See the full eligibility criteria
- Female patients aged 18 -75 ;
- Willing to receive LHRH agonist therapy (premenopausal patients only);
- All patients were histopathologically confirmed to be estrogen receptor (ER) -positive and HER2-positive.
- Treatment-naïve stage II-III patients with tumor stage meeting AJCC version 8 criteria;
- ECOG score 0-1;
- Organ function level must meet the following requirements: (1) bone marrow function ANC ≥ 1.5 x 109/L ; PLT ≥ 100 × 109/L Hb ≥ 90 g/L ; (2) hepatic and renal function TBIL ≤ 1.5 × ULN; AL and AST ≤ 3 × ULN (ALT and AST...
- Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- Received any other anti-tumor therapy at the same time;
- Bilateral breast cancer, inflammatory breast cancer or occult breast cancer;
- Stage IV breast cancer;
- Breast cancer without histopathological diagnosis;
- Other malignant tumors in the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;
- Severe heart, liver and kidney and other vital organ dysfunction;
- Inability to swallow, chronic diarrhea and intestinal obstruction, there are a variety of factors affecting drug administration and absorption;
- Participated in other drug clinical trials within 4 weeks before enrollment;
- Known history of hypersensitivity to the drug components of this protocol; history of immunodeficiency, including positive HIV test, HCV, active viral hepatitis B or other acquired, congenital immunodeficiency diseases...
- Had any cardiac disease, including: (1) cardiac arrhythmia requiring medication or clinically significant; (2) myocardial infarction; (3) heart failure; (4) any other cardiac disease judged by the investigator to be...
- Female patients who are pregnant or lactating, female patients of childbearing potential with a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive...
- According to the investigator 's judgment, there are concomitant diseases that seriously jeopardize the patient' s safety or affect the patient 's completion of the study (including but not limited to uncontrolled...
- Had a documented history of neurological or psychiatric disorders, including epilepsy or dementia.Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in...
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.