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A Randomized, Open, Controlled Phase III Observation of Curative Effect Clinical Study On Locally Advanced Beast Cancer Patients who Switch to GP Regimen NC After Receiving Poor Effect from TAC Regimen NC

A Randomized, Open, Controlled Phase III Observation of Curative Effect Clinical Study On Locally Advanced Beast Cancer Patients who Switch to GP Regimen NC After Receiving Poor Effect from TAC Regimen NC

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021887
Enrollment
Unknown
Registered
2019-03-15
Start date
2019-03-18
Completion date
Unknown
Last updated
2019-03-18

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

Conditions

Locally advanced breast cancer

Interventions

1:Cisplatin plus gemcitabine
2:Vinorelbine bitartrate plus Cisplatin
3:TAC

Sponsors

Affliated Tumor Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Nonpregnant female aged 18-70 years; 2) Physical score between 1-2 according to Eastern Cancer Cooperative Group(ECOG); 3) Inoperable or locally advanced beast cancer patients(non-inflammatory breast cancer,including phase IIB,IIIA,IIIB) confirmed by auxiliary inspections(pathology and CT,etc); 4) At least 1 measurable lesion(lesion diameter=20mm by CT or MRI,lesion diameter=10mm by spiral CT); 5) Without dysfunctions of major organs(with normal blood routine, liver function, renal function, heart function,electrolyte); WBC=4.0×10^9/L, N=1.5×10^9/L,PLT=100×10^9/L, HGB=95g/L, serum bilirubin=1.5 times normal upper limit, ALT & AST=2 times normal upper limit, serum creatinine =1.5mg/dl; with nornal result of chest film, abdominal B ultrasound, contralateral mammography,bone scan; 6) Have the ability of understanding this study and signing informed consent; 7) Efficacy evaluated as SD after 2 cycles of TAC neoadjuvant chemotherapy.

Exclusion criteria

Exclusion criteria: 1) Her-2 (3+) or FISH (+); 2) Allergic to all of the chemotherapy drugs before; 3) Currently receiving other anticancer treatment; 4) Without measurable lesions; 5) Others, including any situation of the following: with uncontrolled central nervous system metastases; with major organ dyfunction and severe heart disease including congestive heart failure, uncontrollable arrhythmia, angina requiring long-term medical treatment, heart valve disease,myocardial infarction and refractory hypertension; pregnant or breast-feeding women; with protracted infectious wound; with past history of mental illness which is not easy to control.

Design outcomes

Primary

MeasureTime frame
pCR;

Countries

China

Contacts

Public ContactBinlin Ma, Xun Li

Affliated Tumor Hospital of Xinjiang Medical University

smxlx@sina.com+86 13809951599, +86 13579818166

Outcome results

None listed

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