Breast CancerPhase 2NCT05983094
Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer
A Phase 2 study testing Utidelone, Carboplatin and Epirubicin in people with Breast Cancer and Neoadjuvant Therapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone based regimen as neoadjuvant treatment With High-risk 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, Neoadjuvant Therapy
- What is being tested?
- Utidelone, Carboplatin and Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Sep 2027
- Phase
- Phase 2
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients who will receive initial treatment, 18-70 years of age；
- Newly diagnosed high-risk early stage (T1c-2, N1; T2, N0) and locally advanced (T1c-2, N2-3; T3-4, N0-3) breast cancer (tumor stage II, III), in which HR+/HER2- T2, N0 patients need to be accompanied by high-risk factors (histological grade 3 or Ki67 ≥ 20%). Triple negative breast cancer(TNBC), HER2 positive (Immunohistochemical(IHC)3+; IHC 2+, FISH amplification) breast cancer, HR negative HER2 IHC 2+ and undetermined result of FISH, HR positive HER2 negative (IHC 0,1+; 2+, FISH amplification) breast cancer confirmed by pathological test.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1
- The blood routine examination was basically normal (CTCAE ≤ 1) within one week before enrollment (based on the normal values of each research center laboratory). No Human Granulocyte Colony Stimulating Factor(rhGCSF) or blood transfusion/erythropoietin(EPO) or other drugs were used within 14 days prior to enrollment.
- White blood cell count (WBC) ≥ 4 x109 / L; Neutrophil count (ANC) > 1.5x109 / L; Platelet count (PLT) ≥ 100×109/L Hemoglobin(Hb) ≥ 100g/L.
- The blood biochemistry examination was basically normal (CTCAE ≤ 1) within one week before enrollment (based on the normal values of each research center laboratory) Serum total bilirubin ≤ Upper limit of normal value(ULN)； Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 1.5×ULN； Alkaline phosphatase ≤ 2.5×ULN； Serum creatinine ≤ 1.5×ULN.
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- Color Doppler echocardiography left ventricular Ejection fraction (LVEF) ≥ 55%
- Female patients with fertility must agree to use effective contraceptive methods during the study period and within 6 months of the last study medication. The Pregnancy test (urine or serum) must be negative
- Be willing and able to provide written informed consent/assent for the trial.
Who cannot join
- Primary stage IV breast cancer；
- Inflammatory breast cancer;
- Bilateral primary breast cancer (including invasive cancer and carcinoma in situ)；
- Previous anti-cancer treatment or radiotherapy for any malignant tumor, excluding cured cervical Carcinoma in situ, skin Basal-cell carcinoma and squamous cell carcinoma.
- Receive any sex hormone treatment (such as contraceptives, ovarian hormone replacement therapy, etc.), except for Ovarian function suppression（OFS）fertility protection, or any hormone drugs (such as Raloxifene, tamoxifen, or other selective estrogen receptor modulators) to treat osteoporosis or prevent breast cancer；
- The patient has undergone major surgery unrelated to breast cancer within 4 weeks before treatment or has not yet fully recovered;
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- Symptomatic peripheral neuropathy CTCAE 5.0 grade ≥ 2
- Serious cardio cerebral Vascular disease, including but not limited to the followings:
- History of congestive heart failure or systolic dysfunction (LVEF<50%);
- Angina pectoris requiring anti angina drugs;
- High risk uncontrolled arrhythmias or severe conduction abnormalities, such as ventricular arrhythmias that require clinical intervention, II-III degree atrioventricular block, etc; Under resting state, the average corrected Q-T interval(QTcF) of three 12 lead electrocardiogram examinations is>470ms;
- Clinically significant heart valve disease with cardiac dysfunction;
- Hypertension that cannot be controlled;
- History of myocardial infarction
- Allergic to any component of any drug in this protocol.
- Those who are not suitable for using Corticosteroid.
- Individuals with active infections who currently require systematic anti infection treatment.
- History of immune deficiency disease, including positive of HIV/AIDS, or other acquired or congenital immune deficiency diseases, or having a history of organ transplantation.
- Who had participated in other drug intervention clinical trials within the 28 days of randomization, or who is participating in another clinical trial or is using other investigational treatments.
- Individuals in pregnancy (positive Pregnancy test) and lactation.
- Any other comorbidities that interfere with the implementation of the treatment plan, or the researcher evaluate that the subject has a history of other serious systemic diseases, or other reasons lead to the patients is unsuitable to participate in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone based regimen as neoadjuvant treatment With High-risk Early-stage or Locally Advanced Breast Cancer.
Read the detailed description
This is a single arm, multi-center study,three-cohort, prospective phase II study which will enroll 181 high-risk early-stage or locally advanced breast cancer patients.
- Conditions
- Breast Cancer, Neoadjuvant Therapy
- Being tested
- Utidelone, Carboplatin, Epirubicin, Trastuzumab, Pertuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UtideloneDrug
Utidelone injection 30mg/m2, on days 1-5 of each cycle
CarboplatinDrug
Carboplatin Area under curve(AUC)6, iv, was administered on day 1
EpirubicinDrug
Epirubicin 75mg/m2 was administered on day 1
TrastuzumabDrug
Trastuzumab 8mg/kg iv in first cycle on day 1, then 6mg/kg in the rest cycles
PertuzumabDrug
Pertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 Triple-negative breast cancer | Experimental | Hormone Receptor(HR) negative, Human Epidermal Growth Factor Receptor 2(HER2 )negative breast cancer Drug: Utidelone in combination with carboplatin Utidelone injection 30mg/m2, on days 1-5 of each cycle; Carboplatin ,Area Under Curve(AUC)6, iv, was administered on day 1; One treatment cycle is 21 days, and there are 6 cycles in total. Receives: Drug: Utidelone; Drug: Carboplatin |
| cohort 2 HR positive, HER2 negative breast cancer | Experimental | HR positive, HER2 negative, Immunohistochemical(IHC)0,1+; 2+, Fluorescence in situ hybridization(FISH)non-amplification breast cancer Drug: Utidelone in combination with Epirubicin Utidelone injection 30mg/m2, on days 1-5 of each cycle; Epirubicin 75mg/m2 was administered on day 1; One treatment cycle is 21 days, and there are 6 cycles in total. Receives: Drug: Utidelone; Drug: Epirubicin |
| cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer | Experimental | Drug: Utidelone in combination with carboplatin, trastuzumab and pertuzumab Utidelone injection 30mg/m2, on days 1-5 of each cycle; Carboplatin Area Under Curve(AUC)6, iv, was administered on day 1; One treatment cycle is 21 days, and there are 6 cycles in total. Trastuzumab 8mg/kg iv in first cycle on day 1, then 8mg/kg in the rest cycles; pertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles.
One treatment cycle is 21 days, and there are 6 cycles in total. Receives: Drug: Utidelone; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pathological complete response (etpCR, Pathologic staging after neoadjuvant therapy(yp)T0/is, (yp)N0)
Percentage of patients with absence of invasive neoplastic cells in ipsilateral lymph nodes and breast
Measured: 24 months
Secondary outcomes (5)
Breast Pathologic Complete Response ((bpCR, Pathologic staging after neoadjuvant therapy(yp)T0/is)
Percentage of patients whose pathological evaluation of hematoxylin and eosin-stained breast samples do not show any residual invasive carcinoma
Measured: 24 months
Event Free Survival(EFS) of 2 years
Time from the first dose of study intervention administration to any of the following events: progression of disease that precludes surgery, local or distant recurrence after surgery, second primary malignancy (breast or other invasive cancers), or death due to any cause.
Measured: 24 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Graded according to the Common Terminology Criteria for Adverse Event (CTCAE) grade and changes in CTCAE grade
Measured: Through study completion，an average of 1 year
Patient reported outcome (PRO)
National Cancer Center of China-Breast Cancer-A 1.0 (NCC-BC-A 1.0) during the study was used to assess the quality of life；The minimum to maximum values: 0 , 100 Meaning: the higher scores mean a better outcome.
Measured: Through study completion，an average of 1 year
Patient reported outcome (PRO)
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-chemotherapy-induced peripheral neuropathy(CIPN) twenty-item scale (QLQ-CIPN20) was used to assess the quality of life.
Measured: Through study completion，an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (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.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Study of Utidelone based neoadjuvant treatment on early high-risk or locally advanced breast cancer
- Masking
- None (open label)
- Enrolment
- 181 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, First Hospital of China Medical University
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983094
- Sponsor's protocol ID
- NCC4047
- Status last verified
- Aug 2023
- First submitted
- 18 Jul 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05983094
- Acronym / sponsor ID
- NCC4047
- Conditions
- Breast Cancer, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 181 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, First Hospital of China Medical University
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 Aug 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 based regimen as neoadjuvant treatment With High-risk Early-stage or Locally Advanced Breast Cancer.
Detailed description
This is a single arm, multi-center study,three-cohort, prospective phase II study which will enroll 181 high-risk early-stage or locally advanced breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Study of Utidelone based neoadjuvant treatment on early high-risk or locally advanced breast cancer
| Arm | Type | Receives |
|---|---|---|
| cohort 1 Triple-negative breast cancer | Experimental | Drug: Utidelone, Drug: CarboplatinHormone Receptor(HR) negative, Human Epidermal Growth Factor Receptor 2(HER2 )negative breast cancer Drug: Utidelone in combination with carboplatin Utidelone injection 30mg/m2, on days 1-5 of each cycle; Carboplatin ,Area Under Curve(AUC)6, iv, was administered on day 1; One treatment cycle is 21 days, and there are 6 cycles in total. |
| cohort 2 HR positive, HER2 negative breast cancer | Experimental | Drug: Utidelone, Drug: EpirubicinHR positive, HER2 negative, Immunohistochemical(IHC)0,1+; 2+, Fluorescence in situ hybridization(FISH)non-amplification breast cancer Drug: Utidelone in combination with Epirubicin Utidelone injection 30mg/m2, on days 1-5 of each cycle; Epirubicin 75mg/m2 was administered on day 1; One treatment cycle is 21 days, and there are 6 cycles in total. |
| cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer | Experimental | Drug: Utidelone, Drug: Carboplatin, Drug: Trastuzumab, Drug: PertuzumabDrug: Utidelone in combination with carboplatin, trastuzumab and pertuzumab Utidelone injection 30mg/m2, on days 1-5 of each cycle; Carboplatin Area Under Curve(AUC)6, iv, was administered on day 1; One treatment cycle is 21 days, and there are 6 cycles in total. Trastuzumab 8mg/kg iv in first cycle on day 1, then 8mg/kg in the rest cycles; pertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles. One treatment cycle is 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 (9 listed)
- Female patients who will receive initial treatment, 18-70 years of age；
- Newly diagnosed high-risk early stage (T1c-2, N1; T2, N0) and locally advanced (T1c-2, N2-3; T3-4, N0-3) breast cancer (tumor stage II, III), in which HR+/HER2- T2, N0 patients need to be accompanied by high-risk factors (histological grade 3 or Ki67 ≥ 20%). Triple negative breast cancer(TNBC), HER2 positive (Immunohistochemical(IHC)3+; IHC 2+, FISH amplification) breast cancer, HR negative HER2 IHC 2+ and undetermined result of FISH, HR positive HER2 negative (IHC 0,1+; 2+, FISH amplification) breast cancer confirmed by pathological test.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1
- The blood routine examination was basically normal (CTCAE ≤ 1) within one week before enrollment (based on the normal values of each research center laboratory). No Human Granulocyte Colony Stimulating Factor(rhGCSF) or blood transfusion/erythropoietin(EPO) or other drugs were used within 14 days prior to enrollment.
- White blood cell count (WBC) ≥ 4 x109 / L; Neutrophil count (ANC) > 1.5x109 / L; Platelet count (PLT) ≥ 100×109/L Hemoglobin(Hb) ≥ 100g/L.
Key exclusion criteria (21 listed)
- Primary stage IV breast cancer；
- Inflammatory breast cancer;
- Bilateral primary breast cancer (including invasive cancer and carcinoma in situ)；
- Previous anti-cancer treatment or radiotherapy for any malignant tumor, excluding cured cervical Carcinoma in situ, skin Basal-cell carcinoma and squamous cell carcinoma.
- Receive any sex hormone treatment (such as contraceptives, ovarian hormone replacement therapy, etc.), except for Ovarian function suppression（OFS）fertility protection, or any hormone drugs (such as Raloxifene, tamoxifen, or other selective estrogen receptor modulators) to treat osteoporosis or prevent breast cancer；
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 |
|---|---|---|
| UtideloneUtidelone injection 30mg/m2, on days 1-5 of each cycle | Drug | cohort 1 Triple-negative breast cancer, cohort 2 HR positive, HER2 negative breast cancer, cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer |
| CarboplatinCarboplatin Area under curve(AUC)6, iv, was administered on day 1 | Drug | cohort 1 Triple-negative breast cancer, cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer |
| EpirubicinEpirubicin 75mg/m2 was administered on day 1 | Drug | cohort 2 HR positive, HER2 negative breast cancer |
| TrastuzumabTrastuzumab 8mg/kg iv in first cycle on day 1, then 6mg/kg in the rest cycles | Drug | cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer |
| PertuzumabPertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles | Drug | cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer |
Primary outcome
Total pathological complete response (etpCR, Pathologic staging after neoadjuvant therapy(yp)T0/is, (yp)N0)
Time frame: 24 months
Percentage of patients with absence of invasive neoplastic cells in ipsilateral lymph nodes and breast
5 secondary outcomes
Breast Pathologic Complete Response ((bpCR, Pathologic staging after neoadjuvant therapy(yp)T0/is)
Time frame: 24 months
Event Free Survival(EFS) of 2 years
Time frame: 24 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Through study completion，an average of 1 year
Patient reported outcome (PRO)
Time frame: Through study completion，an average of 1 year
Patient reported outcome (PRO)
Time frame: Through study completion，an average of 1 year
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 9 Aug 2023.
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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.
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 Phase 2 study testing Utidelone, Carboplatin and Epirubicin in people with Breast Cancer and Neoadjuvant Therapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 9 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: opening soon, as of the sponsor's last update on 9 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total pathological complete response (etpCR, Pathologic staging after neoadjuvant therapy(yp)T0/is, (yp)N0) (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 9 Aug 2023.