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

February 6, 2020 updated by: Herui Yao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

760

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Foshan, Guangdong, China
        • First People's Hospital of Foshan
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This is a multi-center real world study to compare maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and observation in patients with HR-positive MBC who achieved disease control after first-line chemotherapy. Patients were retrospectively enrolled from 3 different medical center.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Capecitabine
1000-1250 mg/m 2 PO twice daily days 1-14, cycled every 28 days
Other Names:
  • Maintenance Chemotherapy
Drug: Liposomal doxorubicin
50 mg/m 2 IV day 1, cycled every 28 days
Other Names:
  • Maintenance Chemotherapy
Drug: Gemcitabine
800-1200 mg/m 2 IV days 1, 8, and 15, cycled every 28 days
Other Names:
  • Maintenance Chemotherapy
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.
Drug: Fulvestrant
500mg IH Days 0, 14, 28, then every 28 days
Other Names:
  • Maintenance Endocrine Therapy
Drug: Anastrozole
1mg PO qd
Other Names:
  • Maintenance Endocrine Therapy
Drug: Letrozole
2.5mg PO qd
Other Names:
  • Maintenance Endocrine Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Estimated 36 months
From enrollment to death (for any reason)
Estimated 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: Estimated 18 months
From enrollment to progression or death (for any reason)
Estimated 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborators

Sun Yat-sen University
First People's Hospital of Foshan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSEC-KY-KS-2019-099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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