NCT04258163

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 760 (actual)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	1000-1250 mg/m 2 PO twice daily days 1-14, cycled every 28 days
DRUG	Liposomal doxorubicin	50 mg/m 2 IV day 1, cycled every 28 days
DRUG	Gemcitabine	800-1200 mg/m 2 IV days 1, 8, and 15, cycled every 28 days
DRUG	Fulvestrant	500mg IH Days 0, 14, 28, then every 28 days
DRUG	Anastrozole	1mg PO qd
DRUG	Letrozole	2.5mg PO qd

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-06-01
• Completion: 2019-07-01
• First posted: 2020-02-06
• Last updated: 2020-02-10

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated drug study