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

Sun Yat-sen University

Status: Completed

Conditions: Metastatic Breast Cancer

Treatments: Drug: Gemcitabine; Drug: Letrozole; Drug: Capecitabine; Drug: Fulvestrant; Drug: Liposomal doxorubicin; Drug: Anastrozole

Study type: Observational

Funder types: Other

Identifiers

NCT04258163

SYSEC-KY-KS-2019-099

Details and patient eligibility

About

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).

Full 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.

Enrollment: 760 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

760 participants in 3 patient groups

MCT Group

Description:

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.

Treatment:

Drug: Liposomal doxorubicin

Drug: Capecitabine

Drug: Gemcitabine

MET Group

Description:

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.

Treatment:

Drug: Anastrozole

Drug: Fulvestrant

Drug: Letrozole

Observation Group

Description:

People who didn't receive any maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks.