Actively Recruiting
Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy
Led by Hunan Cancer Hospital · Updated on 2024-04-26
53
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Female aged 18 years or older
- Pathologically confirmed breast cancer that is triple-negative (ER-negative, PR-negative, HER2-negative)
- Completed full neoadjuvant chemotherapy before surgery without achieving complete remission or with positive lymph nodes
- Neoadjuvant chemotherapy included anthracycline and/or taxane
- Radiotherapy to breast, chest wall, or regional lymph nodes if clinically needed before or after study treatment
- All side effects from prior cancer treatment recovered to Grade 1 (except hair loss)
- Normal blood counts and organ function within 1 week before enrollment
- ECOG performance status of 0 or 1
You will not qualify if you...
- Metastatic breast cancer at diagnosis
- Incomplete breast cancer surgery
- History of other cancers within 5 years except certain in situ carcinomas and skin cancers
- Any serious non-cancer systemic disease interfering with treatment or follow-up
- Symptomatic heart failure, uncontrolled arrhythmia, congenital long QT syndrome, or prolonged QTc
- History of interstitial pneumonia or active pneumonia requiring steroids
- Active autoimmune disease requiring systemic treatment in past 2 years
- Known HIV infection
- Active infections requiring systemic treatment
- Use of hormonal medications like raloxifene or tamoxifen for osteoporosis or breast cancer prevention unless discontinued before enrollment
- Prior use of capecitabine or utidelone before surgery
- Pregnant or breastfeeding
- Known allergy to study drugs or excipients
- Use of corticosteroids prohibited
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Quchang Ouyang
Changsha, Hunan, China, 410083
Actively Recruiting
Research Team
Q
Quchang Ouyang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here