Triple Negative Breast NeoplasmsPhase 2NCT06385990
Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy
A Phase 2 study testing UTD1 in people with Triple Negative Breast Neoplasms, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Neoplasms
- What is being tested?
- UTD1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2024to 29 Mar 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
- Signed informed consent;
- 18 Years and older;
- Female;
- Breast cancer confirmed by pathological histology, ER-negative (<1% positive), PR-negative (<1% positive), and HER2-negative (IHC: HER2 (0), HER2 (1+), or HER2 (2+) and FISH non-amplification;
- Patients must receive full course of neoadjuvant chemotherapy before surgery and did not achieve pathological complete response (i. e., pathologically confirmed residual lesion, maximum diameter of 1cm) or / lymph node positive (ypN+);
- Previous neoadjuvant chemotherapy regimen included anthracycline, taxane, or a combination of both.
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- Patients who clinically require radiotherapy of the affected breast or chest wall and regional lymph node area should receive radiotherapy before or after study medication;
- All toxicities related to previous antitumor therapy must return to Grade 1 (CTCAE v5.0), except alopecia;
- Within 1 week before enrollment, the blood routine examination was basically normal (taking the normal value of each study center as the standard): 1) Blood routine: hemoglobin (Hb) > 90g / L, White blood cell count (WBC) > 3.5*10^9 / L, Number of neutrophils (ANC) * 1.5*10^9 / L, Platelet count (PLT)* 100*10^9 / L; 2) Renal function: upper limit of normal serum creatinine value; 3) Liver function: for patients without liver metastasis: glutamulate aminotransferase (AST), glutamate aminotransferase (ALT), alkaline phosphatase (ALP) are less than 2.5 times of the upper limit of normal value, and totle bilirubin is less than 1.25 times of the upper limit of normal value; for patients with liver metastasis, AST, ALT, ALP, ALT, ALP, are less than 5 times of the upper limit of normal value, and totle bilirubin is less than 1.25 times of the upper limit of normal value;
- The ECOG physical status score for patients must be 0 or 1;
Who cannot join
- Metastatic breast cancer at diagnosis;
- Breast cancer patients who did not completed surgery;
- History of other malignancies within 5 years prior to randomization, but patients with the following tumors may participate in the study: carcinoma of the cervix in situ, colon in situ, melanoma in situ and basal cell carcinoma of the skin and squamous cell carcinoma;
- Any other non-malignant systemic disease (cardiovascular, renal, liver, etc.) that hinders the implementation or follow-up of the treatment program;
- Symptomatic congestive heart failure (New York Heart Association Grade II-IV), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome or corrected QTc> 500ms at screening, history of uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy;
- History of interstitial pneumonia, Need for steroids or evidence of active pneumonia;
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- Suffering from an active autoimmune disease, and required systemic treatment in the past 2 years (i. e., use of disease regulators, corticosteroids, or immunosuppressive drugs);
- Patients with a known infection with human immunodeficiency virus (HIV);
- Patients with active infections requiring systemic treatment;
- Any hormonal medication (such as raloxifene, tamoxifen, or other selective oestrogen receptor modulators) for osteoporosis or breast cancer prophylaxis (only patients who have discontinued these drugs before randomization may participate in the study);
- The patient received either capecitabine or utiderone before surgery;
- Pregnant or lactating women;
- Known or suspected allergy to any study drug or excipients;
- Prohibition of corticosteroids;
- Any other condition the investigator considers inappropriate to participate in the 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, 1 recruiting
- Recruiting
Quchang Ouyang
Changsha, Hunan, 410083
Quchang Ouyang, 8673189762161, oyqc1969@126.com
About this study
Official title: Clinical Study of the Efficacy and Safety of Utidelone (UTD1) Combined With Capecitabine as Adjuvant Therapy in Non-pCR Triple-negative Breast Cancer Patients After Neoadjuvant Therapy
This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug.
Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles.
- Conditions
- Triple Negative Breast Neoplasms
- Being tested
- UTD1
- Keywords
- adjuvant chemotherapy, non-pCR
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UTD1Drug
Also called capecitabine
UTD1: 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| UTD1 in combination with capecitabine | Experimental | UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles. Receives: Drug: UTD1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year disease-free survival (DFS)
2-year DFS will be defined as the percentage of patients alive without recurrence or metastasis of disease at 2 years measured from the date of enrollment.
Measured: 2 years
Secondary outcomes (4)
Overall Survival (OS)
OS was calculated for each patient based on time of enrollment to time of death.
Measured: Up to 2 years (from date of enrollment to the date of death).
Disease Free Survival (DFS)
DFS was measured from surgery to the time of recurrence or metastasis.
Measured: Up to 2 years (from date of surgery to the date of recurrence / metastasis).
Invasive Disease free survival (iDFS)
iDFS was measured from surgery to the time of invasive local, axillary or distant recurrence, invasive contralateral breast cancer or death from any cause (whichever occurs first).
Measured: From the date of surgery to the time of invasive local, axillary or distant recurrence, invasive contralateral breast cancer or death from any cause (whichever occurs first)., up to 2 years.
Distant Disease-free Survival (DDFS)
DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.
Measured: From the date of surgery to distant recurrence, or death due to any cause (up to 2 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start29 Mar 2024
- Primary completion29 Mar 2025 (estimated)
- Study completion29 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385990
- Sponsor's protocol ID
- 2024ks01
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 26 Apr 2024
- 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 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Efficacy and Safety of Utidelone (UTD1) Combined With Capecitabine as Adjuvant Therapy in Non-pCR Triple-negative Breast Cancer Patients After Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT06385990
- Acronym / sponsor ID
- 2024ks01
- Conditions
- Triple Negative Breast Neoplasms
- Keywords
- adjuvant chemotherapy, non-pCR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 29 Mar 2025 (estimated)
- Study completion
- 29 Mar 2027 (estimated)
- First posted
- 26 Apr 2024 (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.
This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug.
Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UTD1 in combination with capecitabine | Experimental | Drug: UTD1UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent;
- 18 Years and older;
- Female;
- Breast cancer confirmed by pathological histology, ER-negative (<1% positive), PR-negative (<1% positive), and HER2-negative (IHC: HER2 (0), HER2 (1+), or HER2 (2+) and FISH non-amplification;
- Patients must receive full course of neoadjuvant chemotherapy before surgery and did not achieve pathological complete response (i. e., pathologically confirmed residual lesion, maximum diameter of 1cm) or / lymph node positive (ypN+);
Key exclusion criteria (15 listed)
- Metastatic breast cancer at diagnosis;
- Breast cancer patients who did not completed surgery;
- History of other malignancies within 5 years prior to randomization, but patients with the following tumors may participate in the study: carcinoma of the cervix in situ, colon in situ, melanoma in situ and basal cell carcinoma of the skin and squamous cell carcinoma;
- Any other non-malignant systemic disease (cardiovascular, renal, liver, etc.) that hinders the implementation or follow-up of the treatment program;
- Symptomatic congestive heart failure (New York Heart Association Grade II-IV), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome or corrected QTc> 500ms at screening, history of uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy;
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 |
|---|---|---|
| UTD1Also: capecitabineUTD1: 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles. | Drug | UTD1 in combination with capecitabine |
Primary outcome
2-year disease-free survival (DFS)
Time frame: 2 years
2-year DFS will be defined as the percentage of patients alive without recurrence or metastasis of disease at 2 years measured from the date of enrollment.
4 secondary outcomes
Overall Survival (OS)
Time frame: Up to 2 years (from date of enrollment to the date of death).
Disease Free Survival (DFS)
Time frame: Up to 2 years (from date of surgery to the date of recurrence / metastasis).
Invasive Disease free survival (iDFS)
Time frame: From the date of surgery to the time of invasive local, axillary or distant recurrence, invasive contralateral breast cancer or death from any cause (whichever occurs first)., up to 2 years.
Distant Disease-free Survival (DDFS)
Time frame: From the date of surgery to distant recurrence, or death due to any cause (up to 2 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 26 Apr 2024.
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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.
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 UTD1 in people with Triple Negative Breast Neoplasms, run by Hunan Cancer 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 15 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: looking for participants now, as of the sponsor's last update on 26 Apr 2024. 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?
Contact Quchang Ouyang (8673189762161, oyqc1969@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year disease-free survival (DFS) (time frame: 2 years). 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 26 Apr 2024.