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Completed

NCT Number: NCT04258163

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

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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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

First People's Hospital of Foshan, Foshan, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Capecitabine

Drug

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

Other names: Maintenance Chemotherapy

Liposomal Doxorubicin

Drug

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

Other names: Maintenance Chemotherapy

Gemcitabine

Drug

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

Other names: Maintenance Chemotherapy

Fulvestrant

Drug

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

Other names: Maintenance Endocrine Therapy

Anastrozole

Drug

1mg PO qd

Other names: Maintenance Endocrine Therapy

letrozole

Drug

2.5mg PO qd

Other names: Maintenance Endocrine Therapy

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Estimated 36 months

    From enrollment to death (for any reason)

Secondary outcomes

  1. Progression free survival (PFS)

    Time frame: Estimated 18 months

    From enrollment to progression or death (for any reason)

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2020
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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