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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • UTD1

    Drug

    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.

Treatment groups

53 Participants
are divided into 1 treatment group
Group A: UTD1 in combination with capecitabineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

Overall Survival (OS)

OS was calculated for each patient based on time of enrollment to time of death.

Time frame
Up to 2 years (from date of enrollment to the date of death).
2

Disease Free Survival (DFS)

DFS was measured from surgery to the time of recurrence or metastasis.

Time frame
Up to 2 years (from date of surgery to the date of recurrence / metastasis).
3

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).

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.
4

Distant Disease-free Survival (DDFS)

DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.

Time frame
From the date of surgery to distant recurrence, or death due to any cause (up to 2 years).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hunan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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