Metastatic Breast Cancer
Conditions
Keywords
Metastatic Breast Cancer, Maintenance Chemotherapy, Maintenance Endocrine Therapy, Overall Survival, Safety
Brief summary
To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic breast cancer (MBC).
Detailed description
There are several options for MBC patients who are responding to chemotherapy, to continue treatment with a fix number of cycles or until disease progression which also known as maintenance chemotherapy (MCT), to stop chemotherapy and take a watch and wait strategy, or to stop chemotherapy and start the maintenance endocrine therapy (MET) for hormone receptor (HR) positive patients. Since the role of maintenance therapy in prolonging the overall survival (OS) and progression-free survival (PFS) of MBC was controversial in previous studies, the investigators performed a systematic review of randomized controlled trials to detect the association of survival with maintenance therapy in patients with MBC after first-line chemotherapy. And the investigators further performed a multi-center retrospective real-world study to evaluate these two maintenance modalities.
Interventions
DRUGCapecitabine
1000-1250 mg/m 2 PO twice daily days 1-14, cycled every 28 days
DRUGLiposomal doxorubicin
50 mg/m 2 IV day 1, cycled every 28 days
DRUGGemcitabine
800-1200 mg/m 2 IV days 1, 8, and 15, cycled every 28 days
DRUGFulvestrant
500mg IH Days 0, 14, 28, then every 28 days
DRUGAnastrozole
1mg PO qd
DRUGLetrozole
2.5mg PO qd
Sponsors
Sun Yat-sen University
First People's Hospital of Foshan
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with pathologically clear invasive breast cancer between 2003 and 2018; * Female,18-75 years old; * Measurable metastatic lesion according to RECIST 1.1 evaluation criteria; * The first-line chemotherapy regimen is a breast cancer combination or single-agent chemotherapy regimen recommended by the NCCN guidelines; * First-line chemotherapy is effective (according to RECIST1.1 evaluation criteria, the efficacy is evaluated as complete response (CR), partial response (PR), or steady state (SD)); * After the last cycle of first-line chemotherapy, patients should still be in a state of no progress for at least 4 weeks; * Patients' Karnofsky performance status (KPS) scores were ≥70.
Exclusion criteria
* Unmeasurable metastatic lesion according to RECIST 1.1 evaluation criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Estimated 36 months | From enrollment to death (for any reason) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | Estimated 18 months | From enrollment to progression or death (for any reason) |
Countries
China
Outcome results
None listed