Breast CancerPhase 3NCT05673629
Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With HER2-negative Breast Cancer
A Phase 3 study testing Utidelone Injection in combination with AC and Docetaxel Injection in combination with AC in people with Breast Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone plus AC versus Docetaxel plus AC as neoadjuvant chemotherapy in high-risk HER2-negative early-stage or locally advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Utidelone Injection in combination with AC and Docetaxel Injection in combination with AC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2023to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients who will receive initial treatment, 18 ≤ years of age ≤70.
- Pathologically confirmed HER2-negative breast cancer at each investigational site with IHC at 0 or 1+, or IHC at 2+ with HER2 being negative by ISH (please refer to the ASCO/CAP Guideline 2020 for the relevant definition).
- For patients with triple negative breast cancer, the requirement is tumor size>2 cm or lymph node-positive (T1, N1-3, M0, T2-4, any N, M0; tumor stage: II or III).
- For patients with HR-positive and HER2-negative breast cancer, the requirement is (T2-4, N1-3, M0 or T2-4, N0 with high risk factors, M0):
- Tumor size>2cm
- lymph node-positive or high-risk factor with pathologically negative lymph node. High risk factors include:
Show all 22Show fewer
- histologic grade 3.
- high Ki67 expression (≥20%).
- Baseline routine blood tests within 1 week prior to enrollment is normal, with CTCAE grade ≤1 (based on normal values at each site's laboratory). No rhG-CSF use and no blood transfusion/EPO etc. within 14 days prior to enrollment.
- White blood cell count ≥ 4.0× 109/L;
- Neutrophil count ≥ 1.5 × 109/L;
- Platelet count ≥ 100 × 109/L;
- Hemoglobin ≥100 g/L.
- Blood biochemistry test result is normal within 1 week prior to enrollment, with CTCAE grade ≤1 (based on normal values at each site's laboratory).
- Total bilirubin ≤ upper limit of normal (ULN).
- AST and ALT ≤ 1.5 x ULN.
- alkaline phosphatase ≤ 2.5×ULN.
- Serum creatinine ≤ 1.5×ULN.
- Left ventricular ejection fraction (LVEF) on cardiac ultrasound ≥55%.
- ECOG performance status 0 or 1.
- Females of childbearing potential must agree to use effective contraception during the study and within 6 months after the last dose. The blood or urine pregnancy test for female patients of childbearing age prior to enrollment must be negative.
- The patient willingly participates in this study, will sign the informed consent form, and commits to following the treatment and follow-up schedule.
Who cannot join
- Stage IV metastatic breast cancer.
- Inflammatory breast cancer.
- Bilateral primary breast cancer (including invasive cancer and carcinoma in situ).
- Patients who have previously received anti-tumor treatment or radiotherapy for any malignancy, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin and squamous cell carcinoma.
- Patients who receive any sex hormone therapy (e.g., birth control pills, hormone replacement therapy, etc.), or any hormonal drug (e.g., raloxifene, tamoxifen, or other selective estrogen receptor modulators) for osteoporosis or breast cancer prevention.
- Patients received major surgical operation unrelated to breast cancer within 4 weeks prior to randomization or having not yet fully recovered.
Show all 21Show fewer
- Patients with symptomatic peripheral neuropathy with CTCAE 5.0 grade ≥ 2.
- Patients with severe cardiovascular diseases, including but not limited to:
- history of congestive heart failure or systolic dysfunction (LVEF < 50%).
- angina requiring anti-anginal medication.
- high-risk uncontrolled arrhythmias or severe conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, etc.; mean QTcF >470ms in 3 12-lead ECGs tests at rest.
- clinically significant heart valve disease with impaired cardiac function.
- Clinically uncontrollable hypertension.
- History of myocardial infarction.
- Patients allergic to any ingredient of any drug to be administered in this study.
- Patients unsuitable for corticosteroids.
- Patients with active infection and currently in need of systemic anti-infective therapy.
- Patients with history of immunodeficiency, including history of HIV, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation.
- Patients who have participated in another interventional drug trial within 28 days prior to randomization or are concurrently participating in another clinical trial or using another investigational treatment.
- Patients during pregnancy (positive pregnancy test), lactation.
- Patients with any other co-morbidities that interfere with the regimens in this study, or in the opinion of the investigator, the subject has a history of other serious systemic disease or other reasons that make participation in this trial inadvisable.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
zhimin shao
About this study
Official title: A Phase III, Open-label, Randomized, Controlled Study of Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With High-risk Early-stage or Locally Advanced HER2-negative Breast Cancer
The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone plus AC versus Docetaxel plus AC as neoadjuvant chemotherapy in high-risk HER2-negative early-stage or locally advanced breast cancer.
In this phase III, multi-center, open-label, randomized controlled study, 552 subjects will be enrolled and randomly assigned in a 1:1 ratio to either the Utidelone plus AC group or the docetaxel plus AC group, stratified by hormone receptor status (ER and/or PgR positive vs ER and PgR negative).
Read the detailed description
The subjects in treatment group will be treated with Utidelone at 30 mg/m2/d administered intravenously once daily on days 1-5 of each cycle, and doxorubicin at 50mg/m2 and cyclophosphamide at 500 mg/m2, administered intravenously once daily on day 1 of each cycle. One treatment cycle has 21 days, and there are in total 6 cycles. The subjects in control group will be treated with docetaxel at 75 mg/m2, doxorubicin at 50 mg/m2, and cyclophosphamide at 500mg/m2, administered intravenously once on day 1 of each cycle. One cycle has 21 days, and there are 6 cycles in total.
After the neoadjuvant therapy, all patients suitable for surgery should take the operation, and patients will be evaluated pre-operatively for clinical remission according to RECIST 1.1. After the surgery, patients will be evaluated for pathological remission, and physicians will recommend, according to clinical practice guidelines and clinical practice at each site, radiotherapy or adjuvant therapy for patients with corresponding clinical indications, and endocrine therapy for ER positive and/or PgR positive patients. Patients unsuitable for surgery receive other treatments according to the clinical practice at each site.
Safety evaluation will be performed 28 days after the last dose, and patients will be followed up for at least 3 years for disease recurrence.
- Conditions
- Breast Cancer
- Being tested
- Utidelone Injection in combination with AC, Docetaxel Injection in combination with AC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utidelone Injection in combination with ACDrug
The treatment group will be treated with Utidelone Injection at 30 mg/m2/d administered intravenously once daily on days 1-5 of each cycle, and Doxorubicin Injection at 50mg/m2 and Cyclophosphamide Injection at 500 mg/m2, administered intravenously respectively once daily on day 1 of each cycle. One treatment cycle has 21 days, and there are 6 cycles in total.
After the neoadjuvant therapy, all patients suitable for surgery will have the operation, and they will be evaluated pre-operatively for clinical remission according to RECIST 1.1. For patients unsuitable for surgery, they will receive other treatments according to the clinical practice at each site.
Safety evaluation will be performed 28 days after the last dose, and patients will be followed up for at least 3 years for disease recurrence.
Docetaxel Injection in combination with ACDrug
The control group will be treated with Docetaxel Injection at 75 mg/m2, Doxorubicin Injection at 50 mg/m2, and Cyclophosphamide Injection at 500mg/m2, administered intravenously once on day 1 of each cycle. One cycle has 21 days, and there are 6 cycles in total.
After the neoadjuvant therapy, all patients suitable for surgery will have the operation, and they will be evaluated pre-operatively for clinical remission according to RECIST 1.1. For patients unsuitable for surgery, they will receive other treatments according to the clinical practice at each site.
Safety evaluation will be performed 28 days after the last dose, and patients will be followed up for at least 3 years for disease recurrence.
| Study group | Role | What they receive |
|---|---|---|
| The treatment group-Utidelone in combination with AC | Experimental | Utidelone Injection at 30 mg/m2/d administered on days 1-5 of each cycle. Doxorubicin Injection at 50mg/m2 and Cyclophosphamide Injection at 500 mg/m2 administered once daily on day 1 of each cycle.
One treatment cycle has 21 days, and there are 6 cycles in total. Receives: Drug: Utidelone Injection in combination with AC |
| The control group-Docetaxel in combination with AC | Active comparator | Docetaxel Injection at 75 mg/m2, Doxorubicin Injection at 50 mg/m2, and Cyclophosphamide Injection at 500mg/m2, administered on day 1 of each cycle.
One cycle has 21 days, and there are 6 cycles in total. Receives: Drug: Docetaxel Injection in combination with AC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pathologic Complete Response
tpCR (ypT0/is, ypN0), percentage of patients with absence of invasive neoplastic cells in ipsilateral lymph nodes and the breast
Measured: 24 months
Secondary outcomes (3)
Breast Pathologic Complete Response
ypT0/is, percentage of patients whose pathological evaluation of hematoxylin and eosin-stained breast samples do not show any residual invasive carcinoma.
Measured: 24 months
Objective Response Rate
Proportion of subjects who get to CR or PR during neoadjuvant therapy
Measured: 24 months
3-year Event Free Survival
Event of interest, which included preoperative disease progression, postoperative disease recurrence, and death from any cause.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start30 May 2023
- Primary completion15 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhimin Shao, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673629
- Sponsor's protocol ID
- BG01-2102
- Status last verified
- Dec 2022
- First submitted
- 30 Dec 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open-label, Randomized, Controlled Study of Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With High-risk Early-stage or Locally Advanced HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05673629
- Acronym / sponsor ID
- BG01-2102
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Jan 2023 (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.
The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone plus AC versus Docetaxel plus AC as neoadjuvant chemotherapy in high-risk HER2-negative early-stage or locally advanced breast cancer.
In this phase III, multi-center, open-label, randomized controlled study, 552 subjects will be enrolled and randomly assigned in a 1:1 ratio to either the Utidelone plus AC group or the docetaxel plus AC group, stratified by hormone receptor status (ER and/or PgR positive vs ER and PgR negative).
Detailed description
The subjects in treatment group will be treated with Utidelone at 30 mg/m2/d administered intravenously once daily on days 1-5 of each cycle, and doxorubicin at 50mg/m2 and cyclophosphamide at 500 mg/m2, administered intravenously once daily on day 1 of each cycle. One treatment cycle has 21 days, and there are in total 6 cycles. The subjects in control group will be treated with docetaxel at 75 mg/m2, doxorubicin at 50 mg/m2, and cyclophosphamide at 500mg/m2, administered intravenously once on day 1 of each cycle. One cycle has 21 days, and there are 6 cycles in total.
After the neoadjuvant therapy, all patients suitable for surgery should take the operation, and patients will be evaluated pre-operatively for clinical remission according to RECIST 1.1. After the surgery, patients will be evaluated for pathological remission, and physicians will recommend, according to clinical practice guidelines and clinical practice at each site, radiotherapy or adjuvant therapy for patients with corresponding clinical indications, and endocrine therapy for ER positive and/or PgR positive patients. Patients unsuitable for surgery receive other treatments according to the clinical practice at each site.
Safety evaluation will be performed 28 days after the last dose, and patients will be followed up for at least 3 years for disease recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The treatment group-Utidelone in combination with AC | Experimental | Drug: Utidelone Injection in combination with ACUtidelone Injection at 30 mg/m2/d administered on days 1-5 of each cycle. Doxorubicin Injection at 50mg/m2 and Cyclophosphamide Injection at 500 mg/m2 administered once daily on day 1 of each cycle. One treatment cycle has 21 days, and there are 6 cycles in total. |
| The control group-Docetaxel in combination with AC | Active comparator | Drug: Docetaxel Injection in combination with ACDocetaxel Injection at 75 mg/m2, Doxorubicin Injection at 50 mg/m2, and Cyclophosphamide Injection at 500mg/m2, administered on day 1 of each cycle. One cycle has 21 days, and there are 6 cycles in total. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Female patients who will receive initial treatment, 18 ≤ years of age ≤70.
- Pathologically confirmed HER2-negative breast cancer at each investigational site with IHC at 0 or 1+, or IHC at 2+ with HER2 being negative by ISH (please refer to the ASCO/CAP Guideline 2020 for the relevant definition).
- For patients with triple negative breast cancer, the requirement is tumor size>2 cm or lymph node-positive (T1, N1-3, M0, T2-4, any N, M0; tumor stage: II or III).
- For patients with HR-positive and HER2-negative breast cancer, the requirement is (T2-4, N1-3, M0 or T2-4, N0 with high risk factors, M0):
- Baseline routine blood tests within 1 week prior to enrollment is normal, with CTCAE grade ≤1 (based on normal values at each site's laboratory). No rhG-CSF use and no blood transfusion/EPO etc. within 14 days prior to enrollment.
Key exclusion criteria (21 listed)
- Stage IV metastatic breast cancer.
- Inflammatory breast cancer.
- Bilateral primary breast cancer (including invasive cancer and carcinoma in situ).
- Patients who have previously received anti-tumor treatment or radiotherapy for any malignancy, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin and squamous cell carcinoma.
- Patients who receive any sex hormone therapy (e.g., birth control pills, hormone replacement therapy, etc.), or any hormonal drug (e.g., raloxifene, tamoxifen, or other selective estrogen receptor modulators) for osteoporosis or breast cancer prevention.
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 |
|---|---|---|
| Utidelone Injection in combination with ACThe treatment group will be treated with Utidelone Injection at 30 mg/m2/d administered intravenously once daily on days 1-5 of each cycle, and Doxorubicin Injection at 50mg/m2 and Cyclophosphamide Injection at 500 mg/m2, administered intravenously respectively once daily on day 1 of each cycle. One treatment cycle has 21 days, and there are 6 cycles in total. After the neoadjuvant therapy, all patients suitable for surgery will have the operation, and they will be evaluated pre-operatively for clinical remission according to RECIST 1.1. For patients unsuitable for surgery, they will receive other treatments according to the clinical practice at each site. Safety evaluation will be performed 28 days after the last dose, and patients will be followed up for at least 3 years for disease recurrence. | Drug | The treatment group-Utidelone in combination with AC |
| Docetaxel Injection in combination with ACThe control group will be treated with Docetaxel Injection at 75 mg/m2, Doxorubicin Injection at 50 mg/m2, and Cyclophosphamide Injection at 500mg/m2, administered intravenously once on day 1 of each cycle. One cycle has 21 days, and there are 6 cycles in total. After the neoadjuvant therapy, all patients suitable for surgery will have the operation, and they will be evaluated pre-operatively for clinical remission according to RECIST 1.1. For patients unsuitable for surgery, they will receive other treatments according to the clinical practice at each site. Safety evaluation will be performed 28 days after the last dose, and patients will be followed up for at least 3 years for disease recurrence. | Drug | The control group-Docetaxel in combination with AC |
Primary outcome
Total Pathologic Complete Response
Time frame: 24 months
tpCR (ypT0/is, ypN0), percentage of patients with absence of invasive neoplastic cells in ipsilateral lymph nodes and the breast
3 secondary outcomes
Breast Pathologic Complete Response
Time frame: 24 months
Objective Response Rate
Time frame: 24 months
3-year Event Free Survival
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Zhimin Shao, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Utidelone Injection in combination with AC and Docetaxel Injection in combination with AC in people with Breast Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd. 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 22 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 8 Nov 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RONGGUO QIU, PhD (01186-56315388, rqiu2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pathologic Complete Response (time frame: 24 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 8 Nov 2023.