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Maintenance treatment of capecitabine in patient with HER 2-positive and triple negative breast cancer: a randomized, open label, blank controlled, multicenter trial

Maintenance treatment of capecitabine in patient with HER 2-positive and triple negative breast cancer: a randomized, open label, blank controlled, multicenter trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019987
Enrollment
Unknown
Registered
2018-12-11
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

breast cancer

Interventions

Treatment group:Capecitabine
Observation group:None

Sponsors

Suining Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female aged from 18 to 70 years old; 2. ECOG score: 0 to 2; 3. Diagnosed as invasive breast cancer by pathological method; 4. Clinical or pathological stage of II or III; 5. Accepted surgical procedure with or without a neoadjuvant chemotherapy; 6. The status is disease-free after the standard adjuvant treatment; 7. Breast cancer subtypes are HER-2 positive or triple negative breast cancer, and not accept the anti-target therapy; 8. Recurrence risk is midrange or high; 9. Patient has the desire to participate in this study, and signed inform consent form.

Exclusion criteria

Exclusion criteria: 1) Patients are in period of pregnancy and breast-feeding, or have a desire of pregnancy; 2) With any severe underlying diseases, can't sustain the chemotherapy; 3) With any malignant tumor simultaneous or heterochronic; 4) Already in any other clinical trial; 5) With a psychiatric disorder or can't comply with the treatment; 6) Having the contraindication to capecitabine; 7) Unable to cooperate the data collection with researcher.

Design outcomes

Primary

MeasureTime frame
Disease-free survival;Safety index;

Secondary

MeasureTime frame
Overall survival;Local recurrence-free survival;Distance disease-free survival;Breast cancer specific survival;

Countries

China

Contacts

Public ContactHongwei Yang

Suining Central Hospital

yhw.sn@163.com+86 18008258079

Outcome results

None listed

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