Advanced Breast Cancer
Conditions
Brief 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.
Interventions
DRUGXC
Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days
DRUGTPC
Any physician's choice as maintenance therapy (except for XC regimen)
Sponsors
Wenjin Yin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* during pregnancy and lactation * Patients with central nervous system metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | From the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)] | Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0. |
Countries
China
Contacts
Primary ContactWenjin Yin, M.D.
Outcome results
None listed