Breast Cancer MetastaticNCT06876636
Zoledronic Acid Combined With EC-T for Triple-Negative Breast Cancer
A study testing Zoledronic Acid Combined with Neoadjuvant Chemotherapy (EC-T) in people with Breast Cancer Metastatic, run by Xijing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Metastatic
- What is being tested?
- Zoledronic Acid Combined with Neoadjuvant Chemotherapy (EC-T)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Hormone receptor status: ER (Estrogen Receptor) <1%, PR (Progesterone Receptor) <1%;
- 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):
- Complete blood count： Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥90×10^9/L; Hemoglobin (Hb) ≥90 g/L;
Show all 10Show fewer
- 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.
- 10、For premenopausal or surgically unsterilized female patients: agree to abstain from sexual intercourse or use effective contraceptive methods during the treatment period and for at least 7 months after the last administration of study treatment.
- 11、Voluntarily participate in this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up visits
Who cannot join
- 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:
Show all 16Show fewer
- A confirmed history of heart failure or systolic dysfunction (LVEF <50%);
- High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate >100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or higher-grade atrioventricular block (i.e., Mobitz Type II second-degree atrioventricular block or third-degree atrioventricular block);
- Angina requiring anti-anginal medication;
- Clinically significant valvular heart disease;
- ECG showing transmural myocardial infarction;
- Poorly controlled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg);
- 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;
- Pregnant or nursing women, women of childbearing potential with a positive baseline pregnancy test, or women of reproductive age who are unwilling to use effective contraceptive measures throughout the trial period and for 7 months after the last administration of study medication;
- Having severe concomitant diseases or other conditions that would interfere with planned treatment, or any other circumstances deemed by the investigator to make the patient unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Open-Label, Single-Arm Clinical Study of Zoledronic Acid Combined With Neoadjuvant Chemotherapy (EC-T) in Patients With Early-Stage and Locally Advanced Triple-Negative Breast Cancer
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.
Read the detailed description
This study is a prospective, open-label, single-arm clinical trial, planning to enroll 99 treatment-naïve patients with early-stage or locally advanced triple-negative breast cancer (clinical stage IIA-IIIC). The neoadjuvant treatment regimen consists of four cycles of chemotherapy with zoledronic acid + liposomal doxorubicin + cyclophosphamide, followed by four cycles of chemotherapy with zoledronic acid + nab-paclitaxel. The study aims to explore the efficacy and safety of zoledronic acid combined with neoadjuvant chemotherapy (EC-T) in the neoadjuvant treatment of early-stage or locally advanced triple-negative breast cancer.
- Conditions
- Breast Cancer Metastatic
- Being tested
- Zoledronic Acid Combined with Neoadjuvant Chemotherapy (EC-T)
- Keywords
- Zoledronic Acid, Neoadjuvant Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic Acid Combined with Neoadjuvant Chemotherapy (EC-T)Drug
Also called Zoledronic Acid
zoledronic acid + liposomal doxorubicin + cyclophosphamide followed by zoledronic acid + nab-paclitaxel Concurrent immunotherapy is permitted: pembrolizumab or toripalimab
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic Acid | Experimental | Zoledronic acid 4 mg on Day 1 every 3 weeks (q3w) plus liposomal doxorubicin 35 mg/m² on Day 1 q3w plus cyclophosphamide 600 mg/m² on Day 1 q3w, for four cycles. Concurrent immunotherapy is permitted: pembrolizumab 200 mg on Day 1 q3w or toripalimab 240 mg on Day 1 q3w.
Thereafter, zoledronic acid 4 mg on Day 1 q3w plus nab-paclitaxel 260 mg/m² on Day 1 q3w for another four cycles. If immunotherapy was given during the first four cycles, it may be continued for the latter four cycles.
A total of eight chemotherapy cycles are planned, with allowance for multiple drug interruptions due to adverse events. Receives: Drug: Zoledronic Acid Combined with Neoadjuvant Chemotherapy (EC-T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) rate
pCR is defined as the absence of invasive tumor cells in the breast and axillary lymph nodes after primary tumor resection (ypT0/is ypN0) as assessed microscopically.
Measured: up to 6 months
Secondary outcomes (4)
Objective Response Rate (ORR)
The proportion of patients evaluated as having a Complete Response (CR) or Partial Response (PR) according to RECIST version 1.1.
Measured: up to 6 months
Clinical Benefit Rate (CBR)
The proportion of patients evaluated as having a CR, PR, or Stable Disease (SD) lasting at least 6 months according to RECIST version 1.1.
Measured: up to 6 months
Disease-Free Survival (DFS)
The time from enrollment to the first occurrence of recurrent disease, which includes ipsilateral or contralateral recurrence of breast cancer, local or regional recurrence, distant metastasis, and death from any cause.
Measured: up to 6 years
Overall Survival (OS)
The time from enrollment to death from any cause.
Measured: up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start10 Mar 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876636
- Sponsor's protocol ID
- KY20252004-C-1
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-Label, Single-Arm Clinical Study of Zoledronic Acid Combined With Neoadjuvant Chemotherapy (EC-T) in Patients With Early-Stage and Locally Advanced Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06876636
- Acronym / sponsor ID
- KY20252004-C-1
- Conditions
- Breast Cancer Metastatic
- Keywords
- Zoledronic Acid, Neoadjuvant Chemotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, open-label, single-arm clinical trial, planning to enroll 99 treatment-naïve patients with early-stage or locally advanced triple-negative breast cancer (clinical stage IIA-IIIC). The neoadjuvant treatment regimen consists of four cycles of chemotherapy with zoledronic acid + liposomal doxorubicin + cyclophosphamide, followed by four cycles of chemotherapy with zoledronic acid + nab-paclitaxel. The study aims to explore the efficacy and safety of zoledronic acid combined with neoadjuvant chemotherapy (EC-T) in the neoadjuvant treatment of early-stage or locally advanced triple-negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zoledronic Acid | Experimental | Drug: Zoledronic Acid Combined with Neoadjuvant Chemotherapy (EC-T)Zoledronic acid 4 mg on Day 1 every 3 weeks (q3w) plus liposomal doxorubicin 35 mg/m² on Day 1 q3w plus cyclophosphamide 600 mg/m² on Day 1 q3w, for four cycles. Concurrent immunotherapy is permitted: pembrolizumab 200 mg on Day 1 q3w or toripalimab 240 mg on Day 1 q3w. Thereafter, zoledronic acid 4 mg on Day 1 q3w plus nab-paclitaxel 260 mg/m² on Day 1 q3w for another four cycles. If immunotherapy was given during the first four cycles, it may be continued for the latter four cycles. A total of eight chemotherapy cycles are planned, with allowance for multiple drug interruptions due to adverse events. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
- Hormone receptor status: ER (Estrogen Receptor) <1%, PR (Progesterone Receptor) <1%;
- 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):
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic Acid Combined with Neoadjuvant Chemotherapy (EC-T)Also: Zoledronic Acidzoledronic acid + liposomal doxorubicin + cyclophosphamide followed by zoledronic acid + nab-paclitaxel Concurrent immunotherapy is permitted: pembrolizumab or toripalimab | Drug | Zoledronic Acid |
Primary outcome
Pathological Complete Response (pCR) rate
Time frame: up to 6 months
pCR is defined as the absence of invasive tumor cells in the breast and axillary lymph nodes after primary tumor resection (ypT0/is ypN0) as assessed microscopically.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 6 months
Clinical Benefit Rate (CBR)
Time frame: up to 6 months
Disease-Free Survival (DFS)
Time frame: up to 6 years
Overall Survival (OS)
Time frame: up to 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Metastatic
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoledronic Acid Combined with Neoadjuvant Chemotherapy (EC-T) in people with Breast Cancer Metastatic, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) rate (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.