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To study the therapeutic effect of oral vinorelbine soft capsule combined with capecitabine on HER2 negative advanced breast cancer.

To study the therapeutic effect of oral vinorelbine soft capsule combined with capecitabine on HER2 negative advanced breast cancer.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023851
Enrollment
Unknown
Registered
2019-06-14
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-06-17

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

Conditions

breast cancer

Interventions

experimental group :vinorelbine soft capsule combined with capecitabine

Sponsors

Hubei Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged =18 years and =70 years; 2. Breast cancer patients confirmed by pathology and conforming to the clinical diagnostic criteria for advanced breast cancer; At least one measurable target lesion (according to RECIST V1.1 standard); 3. HER expression was negative. 4. There are no contraindications to chemotherapy, patients who have received anthracyclines and paclitaxel adjuvant therapy before and have not used capecitabine and/or vinorelbine. 5. Physical condition (KPS) score =70 points; 6. The expected survival time is more than 3 months. 7.The patient (legal representative *) can understand the purpose of treatment, voluntarily accept the treatment plan and agree to follow-up at the later stage, have good compliance and can sign the informed consent form for chemotherapy (including clinical observation tips); 8.The treatment plan should at least include vinorelbine soft capsules.

Exclusion criteria

Exclusion criteria: 1. Patients generally have poor condition and cannot tolerate chemotherapy. 2. The toxicity of previous anti-tumor therapy has not yet recovered to CT CAE (version 4.03) grade 0-1; 3. Positive patients have systemic diseases without stable control, including severe diabetes, hypertension, lung diseases and liver diseases, etc. 4. Is suffering from active infection requiring systematic treatment; 5. Active tuberculosis history, active hepatitis B or hepatitis C patients (HBsAg positive and HBV DNA copy number positive; HBcAb positive) and HIV positive; 6. Patients who are transferred to hospital or give up treatment during treatment; 7. Patients taking other drugs that may affect the effect of chemotherapy during treatment; 8. Pregnant or lactating women patients; Women of childbearing age refuse to accept contraceptive measures; 9. Researchers think that it is not suitable for the group.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
DCR;OS;

Countries

China

Contacts

Public ContactZhong Wei

Hubei Cancer Hospital

18627135966@163.com+86 18971449155

Outcome results

None listed

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