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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-07-01

Brief Summary

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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).

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Detailed Description

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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

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Metastatic Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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MCT Group

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.

Capecitabine

Intervention Type DRUG

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

Liposomal doxorubicin

Intervention Type DRUG

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

Gemcitabine

Intervention Type DRUG

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

MET Group

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.

Fulvestrant

Intervention Type DRUG

500mg IH Days 0, 14, 28, then every 28 days

Anastrozole

Intervention Type DRUG

1mg PO qd

Letrozole

Intervention Type DRUG

2.5mg PO qd

Observation Group

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

No interventions assigned to this group

Interventions

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Capecitabine

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

Intervention Type DRUG

Liposomal doxorubicin

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

Intervention Type DRUG

Gemcitabine

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

Intervention Type DRUG

Fulvestrant

500mg IH Days 0, 14, 28, then every 28 days

Intervention Type DRUG

Anastrozole

1mg PO qd

Intervention Type DRUG

Letrozole

2.5mg PO qd

Intervention Type DRUG

Other Intervention Names

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Maintenance Chemotherapy Maintenance Chemotherapy Maintenance Chemotherapy Maintenance Endocrine Therapy Maintenance Endocrine Therapy Maintenance Endocrine Therapy

Eligibility Criteria

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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.