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

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Capecitabine; Drug: Fulvestrant; Drug: Liposomal doxorubicin; Drug: Anastrozole; Drug: Gemcitabine; Drug: Letrozole

• Registration Number: NCT04258163
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-07-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 760

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MCT Group	Liposomal doxorubicin	People who received chemotherapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
MCT Group	Gemcitabine	People who received chemotherapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
MCT Group	Capecitabine	People who received chemotherapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
MET Group	Fulvestrant	People who received endocrine therapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
MET Group	Anastrozole	People who received endocrine therapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
MET Group	Letrozole	People who received endocrine therapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Estimated 36 months	From enrollment to death (for any reason)

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	Estimated 18 months	From enrollment to progression or death (for any reason)

Trial Locations

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