Breast NeoplasmsPhase 3NCT05172518

Utidelone Plus Capecitabine Versus Taxane Plus Capecitabine in HER2-negative Locally Advanced or Metastatic Breast Cancer

A Phase 3 study testing Taxane plus Intermittent Capecitabine, Utidelone plus Intermittent Capecitabine and Taxane plus Metronomic Capecitabine in people with Breast Neoplasms and Locally Advanced or Metastatic Breast Cancer, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

It is a phase III trial to explore the efficacy and safety of utidelone plus capecitabine versus taxane plus capecitabine in HER2-negative locally advanced or metastatic breast cancer and the differences of metronomic capecitabine and intermittent capecitabine in combination chemotherapy. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer
What is being tested?: Taxane plus Intermittent Capecitabine, Utidelone plus Intermittent Capecitabine and Taxane plus Metronomic Capecitabine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 512 participants
Where: 1 siteChina
Study dates: 1 Mar 2022to 1 Mar 2030
Phase: Phase 3

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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed Informed Consent Form;
Women aged ≥ 18 years;
Patients with locally advanced or metastatic, histologically or cytologically documented breast cancer;
The primary tumor and metastases (if aspirated) are both HER2-negative;
Eastern Cooperative Oncology Group (ECOG) score [0-2] points;
Measurable disease according to RECIST version 1.1;

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Previous chemotherapy with taxane for early breast cancer (eBC; neoadjuvant or adjuvant setting) is permitted if completed ≥12 months before randomisation;
No more than one prior chemotherapy regimen for inoperable locally advanced or metastatic HER2-negative breast cancer;
Hormone receptor positive patients are allowed no more than two lines of prior endocrine therapy for metastatic disease (including CDK4/6 inhibitors, chidamide and PI3K inhibitors, etc.);
Patients must have recovered to ≤ Grade 1 (CTCAE v5.0) from all toxicities related to prior antineoplastic therapy. However, patients with any grade of alopecia are allowed ;
Patients with asymptomatic CNS metastases may be enrolled, if:
Intracranial lesions are evaluable and eligible for systemic therapy only in the absence of extracranial evaluable lesions, or
Patients with stable intracranial lesions after local treatment while there are extracranial evaluable lesions ;
Adequate hematological, hepatic and renal function;
Women of child bearing potential must agree to use a contraceptive method during the treatment period and for at least 90 days after the last dose of experiment treatment;
Life expectancy of at least 12 weeks;
Patients must be able to participate and comply with treatment and follow-up.

Who cannot join

HER-2 positive (IHC + + +, or FISH positive);
Other malignancies (including primary brain or leptomeninges-related tumors) within the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;
Patients who have received anti-tumor therapy within 4 weeks prior to the start of study treatment, including chemotherapy, radical radiotherapy, hormone therapy, biological therapy, immunotherapy or anti-tumor Chinese medicine therapy;
Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before the first dose of treatment, or anticipating for a major surgical procedure during the study;
Symptomatic peripheral neuropathy or CTCAE 5.0 grade ≥ 2;
Experienced grade 3 or above nervous system-related adverse events after treatment with anti-microtubule drugs;

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Received taxane and/or capecitabine-containing adjuvant/neoadjuvant chemotherapy within 1 year prior to the first study treatment;
Received prior first-line chemotherapy containing a taxane or capecitabine;
Symptomatic central nervous system metastases;
Inability to take or absorb oral medications;
Pregnant or lactating women;
Known or suspected hypersensitivity to any of the study drugs or excipients;
Any other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that precludes study treatment implementation or follow-up ；
Any other condition that the investigator considers inappropriate to participate in this trial .
Use of corticosteroids is prohibited.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shusen Wang, MD contact

+86-13926168469

wangshs@sysucc.org.cn

China1 site

Shusen Wang
Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Utidelone Plus Capecitabine Versus Taxane Plus Capecitabine in HER2-negative Locally Advanced or Metastatic Breast Cancer : A Phase III, Open-label, Randomized Controlled Trial

Conditions: Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer
Being tested: Taxane plus Intermittent Capecitabine, Utidelone plus Intermittent Capecitabine, Taxane plus Metronomic Capecitabine, Utidelone plus Metronomic Capecitabine
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Taxane plus Intermittent CapecitabineDrug
Eligible patients will receive treatment with taxane (paclitaxel, nab-paclitaxel or docetaxel , the dosage reference to related prescribing information or clinical practice by investigators) plus capecitabine (1000 mg/ m2 twice daily D1-14 Q3W) for 6 ~8 cycles(for the the patients with SD, PR or CR after 6~8 cycles treatment could choose to receive continuous combination therapy or capecitabine maintenance mono therapy ), or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.
Utidelone plus Intermittent CapecitabineDrug
Eligible patients will receive treatment with utidelone (30 mg/ m2 /day D1-5 Q3W) plus capecitabine (1000 mg/ m2 twice daily D1-14 Q3W) for 6 ~8 cycles(for the the patients with SD, PR or CR after 6~8 cycles treatment could choose to receive continuous combination therapy or capecitabine maintenance mono therapy), or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.
Taxane plus Metronomic CapecitabineDrug
Eligible patients will receive treatment with taxane (paclitaxel, nab-paclitaxel or docetaxel , the dosage reference to related prescribing information or clinical practice by investigators) plus capecitabine ( 500 mg three times daily on days 1-21 Q3W) for 6 ~8 cycles(For the the patients with SD, PR or CR after 6~8 cycles treatment could choose to receive continuous combination therapy or capecitabine maintenance mono therapy), or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.
Utidelone plus Metronomic CapecitabineDrug
Eligible patients will receive treatment with utidelone (30 mg/ m2 /day D1-5 Q3W) plus capecitabine (500 mg three times daily on days 1-21 Q3W) for 6 ~8 cycles(for the the patients with SD, PR or CR after 6~8 cycles treatment could choose to receive continuous combination therapy or capecitabine maintenance mono therapy ), or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.

Study groups in NCT05172518
Study group	Role	What they receive
Arm A	Active comparator	Taxane plus Intermittent Capecitabine Receives: Drug: Taxane plus Intermittent Capecitabine
Arm B	Experimental	Utidelone plus Intermittent Capecitabine Receives: Drug: Utidelone plus Intermittent Capecitabine
Arm C	Active comparator	Taxane plus Metronomic Capecitabine Receives: Drug: Taxane plus Metronomic Capecitabine
Arm D	Experimental	Utidelone plus Metronomic Capecitabine Receives: Drug: Utidelone plus Metronomic Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS)
Time from randomization to progression or death (whichever occurred first).
Measured: up to 60 months

Secondary outcomes (4)

Objective response rate (ORR)
The proportion of patients with a best response of CR or PR, according to RECIST 1.1 criteria.
Measured: up to 60 months
Time to response (TTR)
the time from randomization to the first documentation of disease response (CR or PR).
Measured: up to 60 months
Duration of response (DOR)
the time from the first evaluation that criteria for CR or PR are met until PD or death is observed, whichever occurs first, calculated only for patients whose best response is evaluated as CR or PR.
Measured: up to 60 months
Overall survival (OS)
Time from randomization to death Time from randomization to death Time from randomization to death Time from randomization to death.
Measured: up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20221 Mar 2030

First posted29 Dec 2021
Study start1 Mar 2022 (estimated)
Primary completion1 Mar 2027 (estimated)
Study completion1 Mar 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 512 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05172518
Sponsor's protocol ID: SYSU-2021-UCAN
Status last verified: Dec 2021
First submitted: 27 Dec 2021
Last updated: 29 Dec 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Shusen Wang, MD

+86-13926168469

wangshs@sysucc.org.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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