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

NCT04258163 | Completed DMC FDA Drug

• 1 other identifier: SYSEC-KY-KS-2019-099
• Study Type: observational
• Target: 760
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; Maintenance Chemotherapy; Maintenance Endocrine Therapy; Overall Survival; Safety

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  From enrollment to death (for any reason)

  Estimated 36 months

Secondary Outcomes (1)

• Progression free survival (PFS)

  Estimated 18 months

Study Arms (3)

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; Drug: Liposomal doxorubicin; Drug: Gemcitabine

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; Drug: Anastrozole; Drug: Letrozole

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.

Interventions

Capecitabine DRUG

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

Also known as: Maintenance Chemotherapy

MCT Group

Liposomal doxorubicin DRUG

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

Also known as: Maintenance Chemotherapy

MCT Group

Gemcitabine DRUG

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

Also known as: Maintenance Chemotherapy

MCT Group

Fulvestrant DRUG

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

Also known as: Maintenance Endocrine Therapy

MET Group

Anastrozole DRUG

1mg PO qd

Also known as: Maintenance Endocrine Therapy

MET Group

Letrozole DRUG

2.5mg PO qd

Also known as: Maintenance Endocrine Therapy

MET Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Unmeasurable metastatic lesion according to RECIST 1.1 evaluation criteria.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Sun Yat-sen University: collaborator
• First People's Hospital of Foshan: collaborator

Study Sites (3)

First People's Hospital of Foshan

Foshan, Guangdong, China

Location

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• Ren W, Yu Y, Hong H, Wang Y, Gao Q, Chen Y, Chen P, Zhao J, Ou Q, Lin D, Fu T, Tan Y, Li C, Xie X, Ye G, Tang J, Yao H. Clinical Evidence of Chemotherapy or Endocrine Therapy Maintenance in Patients with Metastatic Breast Cancer: Meta-Analysis of Randomized Clinical Trials and Propensity Score Matching of Multicenter Cohort Study. Cancer Res Treat. 2022 Oct;54(4):1038-1052. doi: 10.4143/crt.2021.698. Epub 2022 Feb 4.

  PMID: 35130417 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Maintenance Chemotherapy; liposomal doxorubicin; Gemcitabine; Fulvestrant; Anastrozole; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Therapy; Therapeutics; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles

Study Officials

• Herui Yao, PhD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: January 1, 2019
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)