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The value of circulating tumor DNA monitoring in the management of the endocrine therapy of fluvistam in estrogen receptor positive breast cancer patients

The value of circulating tumor DNA monitoring in the management of the endocrine therapy of fluvistam in estrogen receptor positive breast cancer patients

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000033307
Enrollment
Unknown
Registered
2020-05-27
Start date
2020-05-20
Completion date
Unknown
Last updated
2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Estrogen receptor positive breast cancer

Interventions

case series:Fulvestrant

Sponsors

Cancer Hospital Affiliated to Chongqing University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who voluntarily participated in the trial and signed the informed consent; 2. Patients aged 18-75 (including border), female; 3. Patients with locally advanced or metastatic postmenopausal breast cancer confirmed by pathology; 4. Patients with ECoG score of 0-2; 5. HR positive patients were detected by IHC, HER2 was not amplified; 6. The patients who want to receive the endocrine therapy of fluvastatin; 7. Patients with sufficient organ and bone marrow functions (results within 14 days before screening are acceptable) are defined as follows: bone marrow: platelets >= 90 x 10 ^ 9 / L, hemoglobin >= 90g / L, leukocytes >= 3.0 x 10 ^ 9 / L, neutrophils >= 1.5 x 10 ^ 9 / L; liver: total bilirubin = 28g / L; kidney: serum creatinine = 50ml / min; other important organs without severe organic diseases; 8. Patients with expected survival time > 6 months.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with clinically diagnosed other malignant tumors; 3. Patients with skin, musculoskeletal, heart, cardio cerebrovascular, blood system, liver, kidney, digestive tract, immune system, endocrine system, nervous system, respiratory system, mental and metabolic diseases, who are not suitable for the study; 4. Patients with uncontrolled active infection (such as active hepatitis, HIV, syphilis and other infections requiring systemic treatment); 5. Subjects with research conflict diseases: mental illness or drug abuse, etc; 6. Patients who apply other anti-tumor measures before and at the same time of the trial or who plan to participate in other clinical trials; 7. Subjects may not be able to complete the study for other reasons, or the researchers think it should not be included.

Design outcomes

Primary

MeasureTime frame
ctDNA;Mutation feature of tissue;Progress-free survival;

Countries

China

Contacts

Public ContactWeiqi Nian

Cancer Hospital Affiliated to Chongqing University

nwqone@126.com+ 86 13883652913

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026