Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy
ConditionTriple Negative Breast Neoplasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorHunan Cancer Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- UTD1
Treatment groups
53 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov