Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer

NCT ID: NCT03786575

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2021-12-31

Brief Summary

To determine the landscape of gene mutation before and after endocrine therapy, to search for molecular markers of endocrine therapy efficacy, and to explore the clinical value of using NGS detection of ctDNA to guide precise endocrine therapy in patients with advanced breast cancer. The primary endpoints were progression-free survival (PFS), and the secondary endpoints included overall survival time (OS), adverse events (AE), and severe adverse events (SAE).

Detailed Description

Before treatment, the patients in the study group underwent NGS detection of ctDNA and formulated treatment plan according to the test results: 1) those with ESR1 mutation and who did not use fulvestrant before, preferred fulvestrant; 2) those with abnormal activation of PI3K/Akt/mTOR pathway signal, preferred mTOR inhibitor combined with endocrine therapy; 3) those with HER-2 sensitive point mutation, preferred anti-HER-2 therapy combined with endocrine therapy; 4) PDGFR mutation, preferential use of PDGFR inhibitors combined with endocrine therapy; 5) no significant gene mutation, making endocrine therapy plan according to the actual clinical situation. After 2 months of endocrine therapy, all patients underwent NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard. If the efficacy evaluation is effective, continue the current treatment and re-evaluate the efficacy every two months; if the efficacy evaluation is ineffective (progress), then withdraw from this study. The vital signs, blood routine, liver and kidney functions and imaging examinations were examined at least every two months in the patients in the study group, and the curative effect was evaluated according to RECIST v1.1 standard.

Conditions

Breast Neoplasm Female; Therapeutics; Mutation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NGS detection group

Before treatment, the patients in the study group underwent NGS detection of ctDNA and formulated endocrine treatment plan according to the test results. After 2 months of endocrine therapy, all patients underwent NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard.

Group Type: EXPERIMENTAL

Next Generation Sequencing (NGS) detection

Intervention Type: DIAGNOSTIC_TEST

The NGS detection panel is designed by our team and covers genes that are clinically useful and have definite guiding significance for endocrine therapy

Interventions

Next Generation Sequencing (NGS) detection

The NGS detection panel is designed by our team and covers genes that are clinically useful and have definite guiding significance for endocrine therapy

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years, female；

2. Pathologically and immunohistochemically confirmed ER-positive/HER-2-negative patients with advanced breast cancer；

3. According to RECIST standard, lesions can be measured (primary lesion length > 1.0 cm or lymph node diameter > 1.5 cm)；

4. Previous endocrine therapy resistance, preparation for second-or-above-line endocrine therapy；

5. No visceral crisis；

6. ECOG PS score: 0-2 points;

7. Laboratory criteria:

① white blood cells were more than 4 x 109 /L, and neutrophil count (ANC) was more than 1.5 x 109 /L.

② platelet (>100 *109/L); hemoglobin (>10g/dL); serum creatinine (<1.5 *normal value) upper limit (ULN); aspartate aminotransferase (AST) (<2.5 *ULN); alanine aminotransferase (ALT) (<2.5 *ULN); total bilirubin (<1.5 *ULN); serum creatinine (<1.5 *ULN);

8. the volunteers voluntarily joined the study, signed informed consent, and had good compliance and follow-up.

Exclusion Criteria

1. Pregnant or lactation woman

2. With mental disease

3. With severe infection or active gastrointestinal ulcers

4. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes

5. taking part or participating in other clinical trials within one month.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College

OTHER

Sponsor Role: lead

Responsible Party

Fei Ma

Deputy Director of Oncology Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Fei Ma, Dr.

Role: CONTACT

drmafei@126.com

+86-13910217780

Facility Contacts

Fei Ma, Dr.

Role: primary

Other Identifiers

NCC1787

Identifier Type: -

Identifier Source: org_study_id