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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04258163
• Other study ID #: SYSEC-KY-KS-2019-099
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: February 2020
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 760
• Est. completion date: July 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Capecitabine
1000-1250 mg/m 2 PO twice daily days 1-14, cycled every 28 days
• Liposomal doxorubicin
50 mg/m 2 IV day 1, cycled every 28 days
• Gemcitabine
800-1200 mg/m 2 IV days 1, 8, and 15, cycled every 28 days
• Fulvestrant
500mg IH Days 0, 14, 28, then every 28 days
• Anastrozole
1mg PO qd
• Letrozole
2.5mg PO qd

Locations

Country	Name	City	State
China	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

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	First People's Hospital of Foshan, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	From enrollment to death (for any reason)	Estimated 36 months
Secondary	Progression free survival (PFS)	From enrollment to progression or death (for any reason)	Estimated 18 months