Zoledronic Acid Combined With EC-T for Triple-Negative Breast Cancer (NCT06876636) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Zoledronic Acid Combined With EC-T for Triple-Negative Breast Cancer
China99 participantsStarted 2025-03-10
Plain-language summary
Exploring the efficacy and safety of zoledronic acid combined with neoadjuvant chemotherapy (EC-T) in neoadjuvant treatment for early-stage or locally advanced triple-negative breast cancer, the trial protocol of zoledronic acid + liposomal doxorubicin + cyclophosphamide followed by zoledronic acid + nab-paclitaxel will provide a new effective therapeutic strategy for neoadjuvant treatment of triple-negative breast cancer patients and offer a novel treatment approach for triple-negative breast cancer.
Who can participate
Age range
18 Years – 75 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
. Female patients aged ≥18 years and ≤75 years who have not received prior treatment;
. ECOG score of 0 to 1;
. Her-2 (0), Her-2 (1+), Her-2 (2+) must test negative by ISH (in situ hybridization).
. The functional levels of major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of white blood cell or platelet-raising drugs):
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.
. Blood chemistry Total bilirubin (TBIL) ≤ upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; Alkaline phosphatase ≤2.5×ULN; Blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;
. Echocardiogram Left ventricular ejection fraction (LVEF) ≥55%; 9、12-lead ECG QTc interval corrected by Fridericia's method (QTcF) \<470 msec.
Exclusion criteria
. Stage IV (metastatic) breast cancer;
. Inflammatory breast cancer;
. A history of receiving anti-cancer treatment or radiotherapy for any malignant tumor, excluding curative treatments for in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma, etc.;
. Concurrently participating in other clinical trials involving anti-cancer therapies, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
. Having undergone significant non-breast cancer related surgical procedures within 4 weeks prior to enrollment, or not having fully recovered from such procedures;
. Severe cardiac disease or conditions, including but not limited to the following:
. Inability to swallow, intestinal obstruction, or other factors affecting drug intake and absorption;
. Known history of allergies to the components of the study medication: a history of immunodeficiency, including positive HIV tests, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;