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Neoadjuvant Chemotherapy For Breast Cancer

Neoadjuvant Chemotherapy For Breast Cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001043
Enrollment
Unknown
Registered
2014-09-21
Start date
2009-09-01
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

1:weekly paclitaxel-epirubicin (PE)
2:triweekly 5-uorouracil(5-FU)-epirubicin-cyclophos

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: A woman will be eligible for inclusion in this study if she meets all of the following criteria: 1. Aged >=18 to =3cm or LABC(stage III) without distant metastasis; 4. Has at least one clinically measurable focus; 5. Has had no prior chemotherapy; 6. Has had no history of other neoplasms (except nonmelanoma skin cancer or curatively treated carcinoma-in-situ of the cervix); 7. Has adequate bone marrow, normal CBC(neutrophils >=2.5*10^9/L, platelets>=100*10^9/L, Hb>= 100g/L), without blood coagulation disorder; 8. Has adequate renal (serum creatinine=55%; 11. If fertile, patient has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study; female patients of childbearing have agreed to terminate the pregnancy; 12. Has signed a Patient Informed Consent Form and agreed to accept the preoperative chemotherapy, aspiration biopsy and other necessary treatment.

Exclusion criteria

Exclusion criteria: A woman will be excluded from this study if she meets any of the following 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. Has ever had a myocardial infarction (MI) or has a history of congestive heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or uncontrolled hypertension (systolic pressure>180mmHg or diastolic pressure>100mmHg). 5. Is pregnant and unwilling to terminate the pregnancy. 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
Breast Conservation Therapy (BCT) Rate;Pathologic Complete Response (pCR);

Countries

China

Contacts

Public ContactQing Lv
lqlq1963@163.com+86 18980601465

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 10, 2026