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The clinical trial of adjuvant chemotherapy for old breast cancer female

The clinical trial of adjuvant chemotherapy for old breast cancer female

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001670
Enrollment
Unknown
Registered
2011-10-31
Start date
2012-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

the breast cancer

Interventions

B:postoperation chemotherapy(TC:docetaxel 75 mg/m2 IV d1. cyclophosphamidum 600 mg/m2 IV d1. 21d is a cycle and totally 6 cycles
A:without postoperation

Sponsors

The Breast and Thyroid Department of West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
70 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Femal, age >=70 years old when get into inpatient firstly, the exepcted duration survival>= 6months; 2. Has invasive breast cancer (inflammatory breast cancer or DCIS with microinvasive excluded) confirmed by core needle biopsy (CNB) and pathologic analysis; 3. The ER, PR and HER-2 all were negative confirmed by postoperation pathology, or the HER-2 was positive but the patients refused the threatment of herceptin; 4. The metastasis of axillary lymph node>=1 (micrometasasis excluded); 5. without history of other neoplasms (except nonmelanoma skin cancer or curatively treated carcinoma-in-situ of the cervix); 6. adequate bone marrow, normal CBC(neutrophils >=2.5*10^9/L, platelets>=100*10^9/L, Hb>= 100g/L), without blood coagulation disorder; 7. adequate renal (serum creatinine=55%; 10. agreed to accept the postoperative chemotherapy and other necessary treatment; 11. signed a Patient Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. Has had previous systemic chemotherapy or local treatment for this breast cancer (topical application excluded); 2. Has any evidence of distant metastasis at diagnosis of breast cancer; 3. Has a serious uncontrolled intercurrent medical illness, including serious viral (including clinically defined AIDS), bacterial or fungal infection; or history of uncontrolled peptic ulcers, or diabetes, or blood coagulation disorders, or autoimmune diseases, or bone marrow suppression, etc. deemed by the treating physician to be clinically impossible to tolerate the chemotherapy; 4. heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or uncontrolled hypertension (systolic pressure>180mmHg or diastolic pressure>100mmHg); 5. Unwilling to undergo the postoperation chemotherapy; 6. Has history of psychiatric disorders and other unidentified medical problems resulting in poor compliance to the treatment; 7. Has a history of severe hypersensitivity reaction to preparations pertaining to the chemotherapy.

Design outcomes

Primary

MeasureTime frame
disease free survival(DSF);overall survival(OS);

Countries

China

Contacts

Public ContactChen Jie
chenjiedoctor@126.com+86 13980923773

Outcome results

None listed

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