Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University760 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

760

Conditions

Metastatic Breast Cancer

Interventions

CapecitabineDRUG

1000-1250 mg/m 2 PO twice daily days 1-14, cycled every 28 days

Liposomal doxorubicinDRUG

50 mg/m 2 IV day 1, cycled every 28 days

GemcitabineDRUG

800-1200 mg/m 2 IV days 1, 8, and 15, cycled every 28 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (3)

First People's Hospital of Foshan

Foshan, Guangdong, China

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Overall Survival (OS)

From enrollment to death (for any reason)

Time frame: Estimated 36 months

Secondary Outcomes

Progression free survival (PFS)

From enrollment to progression or death (for any reason)

Time frame: Estimated 18 months

Data from ClinicalTrials.gov

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