Treatment of HER-2 negative breast cancer by neoadjuvant chemotherapy combined with WTPA

A double-blind, randomized, placebo-controlled, clinical trial of neoadjuvant chemotherapy combined with WTPA for HER-2 negative locally advanced breast cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10000794

Enrollment

Unknown

Registered

2010-03-11

Start date

2010-03-01

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

HER-2 negative locally advanced breast cancer

Interventions

A:Neoadjuvant chemotherapy (Paclitaxel 80 mg/m2, IV, d1, d8, d15, plus Carboplatin AUC=2, IV, d1, d8, d15, every 28 days for 4 cycles) + WTPA (1 ml, sc, qod, from the start of chemotherapy until 3 day

B:Neoadjuvant chemotherapy (Paclitaxel 80 mg/m2, IV, d1, d8, d15, plus Carboplatin AUC=2, IV, d1, d8, d15, every 28 days for 4 cycles) + Placebo (1 ml, sc, qod, from the start of chemotherapy until 3

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female, aged 18-70 years; 2. Histologically confirmed primary, operable, invasive breast cancer. No evidence of distant metastases by CT, type-B ultrasonic and whole body bone scan, clinical stage IIA~IIIB (T2-3, N0-2, M0); 3. HER-2 negative confirmed by IHC (negative or 1+) or FISH (negative); 4. No previous treatment including surgery (except for core biopsy), chemotherapy, endocrine therapy and local radiotherapy; 5. Karnofsky performance status>=70%; Eastern Cooperative Oncology Group (ECOG) performance status 0~2; 6. Adequate cardiac, hepatic, renal and hematologic function; 7. Laboratory test: WBC>=4*10^9/L, Hb>=90 g/L, plt>=100*10^9/L; 8. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation; 2. Any concurrent malignancy other than breast cancer; 3. Participated in other clinical trial in the recent past two months; 4. Severe uncontrolled internal medicine diseases and active infection; 5. Any evidence of sense or motor nerve disorders; 6. History of drug allergy to WTPA or others; 7. Can not understand the purpose of this clinical study or do not agree with study requirements.

Design outcomes

Primary

Measure	Time frame
Pathological complete responses (pCR);	—

Secondary

Measure	Time frame
Clinical complete responses (cCR), Clinical stage, Safety, Tumor metastasis-related indicators, Immune factors, DFS, OS;	—

Contacts

Public ContactZhi-Min Shao

zhimingshao@yahoo.com+86 021 64175590-8807

Outcome results

None listed

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