BridgeMD
New treatment option for Breast Cancer
Official title Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer
ClinicalTrials.gov ID: NCT06276868
What this study is testing
What is Dalcilib+letrozole+HP treatment group?
Dalcilib+letrozole+HP treatment group is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for breast cancer.
Also referred to as experimental group.
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 study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy.
- Phase 2: a mid-size study of how well it works
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 70, women only
You may be able to join if
- Female initial treatment patients aged ≥ 18 years and ≤ 70 years.
- ECOG score 0-1 points.
- Pathologically confirmed as invasive breast cancer, with tumor staging of II-IIIA.
- HR positive HER-2 positive.
- The main organs function normally and meet the following standards: （1）The blood routine examination standards must comply with:ANC ≥1.5×10 9/L；PLT...
You likely can't join if
- Stage IV (metastatic) breast cancer.
- inflammatory breast cancer.
- Previously received anti-tumor therapy or radiation therapy for any malignant tumor, excluding cured cervical cancer in situ, basal cell carcinoma...
- Simultaneously receiving anti-tumor therapies in other clinical trials, including endocrine therapy, bisphosphate therapy, or immunotherapy.
- The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully...
- Individuals who have previously suffered from clinically significant lung diseases, including but not limited to interstitial pneumonia, pneumonia...
See the full eligibility criteria
- Female initial treatment patients aged ≥ 18 years and ≤ 70 years.
- ECOG score 0-1 points.
- Pathologically confirmed as invasive breast cancer, with tumor staging of II-IIIA.
- HR positive HER-2 positive.
- The main organs function normally and meet the following standards: （1）The blood routine examination standards must comply with:ANC ≥1.5×10 9/L；PLT ≥100×109/L；Hb ≥90g/L. （2）Biochemical examination must meet the...
- Stage IV (metastatic) breast cancer.
- inflammatory breast cancer.
- Previously received anti-tumor therapy or radiation therapy for any malignant tumor, excluding cured cervical cancer in situ, basal cell carcinoma, or squamous cell carcinoma.
- Simultaneously receiving anti-tumor therapies in other clinical trials, including endocrine therapy, bisphosphate therapy, or immunotherapy.
- The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures.
- Individuals who have previously suffered from clinically significant lung diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis, and radiation pneumonia (excluding radiation...
- Serious heart disease or discomfort, including but not limited to the following diseases: （1）Confirmed history of heart failure or systolic dysfunction (LVEF\ 180 mmHg and/or diastolic blood pressure\>100 mmHg)； 8...
The study team makes the final eligibility decision.
Where it's taking place
- Henan, Henan, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Henan, Henan, 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.