Advanced Breast CancerNCT05876065
Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer
A study testing XC and TPC in people with Advanced Breast Cancer, run by Wenjin Yin at 1 site in China.
Trial summary
To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- XC and TPC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to Feb 2028
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, age≥18 years old
- ECOG≤2
- Pathologically confirmed primary breast cancer, with pathologically or radiologically confirmed recurrent or metastatic lesions
- HR+/HER2+ or HR-/HER2+ or HR-/HER2-
- At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
- Disease control (complete response + partial response + stable disease) after salvage treatment
- Expected survival ≥6 months
- Adequate organ function
Who cannot join
- during pregnancy and lactation
- Patients with central nervous system metastasis
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
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127
Wenjin Yin, 86(21)68385569, yinwenjin@renji.com
About this study
Official title: Efficacy and Safety of Capecitabine and Cyclophosphamide (XC) Versus Physician's Choice as Maintenance Therapy for Advanced Breast Cancer: a Randomized, Controlled, Open-label Clinical Trial
To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.
- Conditions
- Advanced Breast Cancer
- Being tested
- XC, TPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XCDrug
Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days
TPCDrug
Any physician's choice as maintenance therapy (except for XC regimen)
| Study group | Role | What they receive |
|---|---|---|
| capecitabine and cyclophosphamide (XC) | Experimental | capecitabine and cyclophosphamide as maintenance therapy every 3 weeks Receives: Drug: XC |
| physician's choice | Active comparator | Any physician's choice as maintenance therapy (except for XC regimen). Receives: Drug: TPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.
Measured: From the date of starting maintenance therapy to the date of first documentation of disease progression or death from any cause (up to approximately 1 year)
Secondary outcomes (1)
Adverse events
Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.
Measured: From the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Jun 2023
- Primary completionJun 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenjin Yin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenjin Yin, RenJi Hospital
- Investigators
- Wenjin Yin, M.D., Principal investigator, Renji Hospital,School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876065
- Sponsor's protocol ID
- LY2023-073-A
- Status last verified
- Aug 2026
- First submitted
- 14 May 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Capecitabine and Cyclophosphamide (XC) Versus Physician's Choice as Maintenance Therapy for Advanced Breast Cancer: a Randomized, Controlled, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT05876065
- Acronym / sponsor ID
- LY2023-073-A
- Conditions
- Advanced Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Wenjin YinUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 25 May 2023 (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.
To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| capecitabine and cyclophosphamide (XC) | Experimental | Drug: XCcapecitabine and cyclophosphamide as maintenance therapy every 3 weeks |
| physician's choice | Active comparator | Drug: TPCAny physician's choice as maintenance therapy (except for XC regimen). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female, age≥18 years old
- ECOG≤2
- Pathologically confirmed primary breast cancer, with pathologically or radiologically confirmed recurrent or metastatic lesions
- HR+/HER2+ or HR-/HER2+ or HR-/HER2-
- At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
Key exclusion criteria (2 listed)
- during pregnancy and lactation
- Patients with central nervous system metastasis
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 |
|---|---|---|
| XCCapecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days | Drug | capecitabine and cyclophosphamide (XC) |
| TPCAny physician's choice as maintenance therapy (except for XC regimen) | Drug | physician's choice |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From the date of starting maintenance therapy to the date of first documentation of disease progression or death from any cause (up to approximately 1 year)
PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.
1 secondary outcome
Adverse events
Time frame: From the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)]
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 19 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Wenjin Yin, M.D. principal investigator
Renji Hospital,School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XC and TPC in people with Advanced Breast Cancer, run by Wenjin Yin 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 8 inclusion and 2 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 19 Aug 2026. 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.
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 Wenjin Yin, M.D. (86(21)68385569, yinwenjin@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From the date of starting maintenance therapy to the date of first documentation of disease progression or death from any cause (up to approximately 1 year)). 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 19 Aug 2026.