Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer

Hospital Affiliated to Military Medical Science, Beijing

Status: Unknown

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01732939

307BCNeo-01

Details and patient eligibility

About

The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.

Full description

The investigators hope to get preliminary results for the breast cancer patients who are given different neoadjuvant chemothetapy regimens. The patients are randomized two chemotherapy regimens. One is anthracyclines plus taxanes for 6-8 cycles,the other is anthracyclines plus taxanes for 3-4 cycles ,then switch tovinorelbine plus cisplatinum for 3-4 cycles.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of invasive ductal or lobular breast cancer.

• Previously untreated (no chemotherapy or hormonal therapy or radiation therapy) invasive breast cancer.

• no anti-Her2 therapy if HER2 positive ( defined as 3+ IHC or FISH positive)

• Performance Status ECOG <2

• Age > 18 years

• Tumor > 2.0 cm by MRI and/or sonographic or clinical exam measurements.or Karnofsky >50%

• Lab test :

  • Absolute neutrophil count > 1,500/mm3

    • Total Bilirubin ≤ 2×ULN
    • AST and ALT ≤ 2.5×ULN

  • serum creatinine ≤ 1.5×ULN

Exclusion criteria

• Pregnant or breast feeding patients are excluded
• stage Ⅳ breast cancer
• History of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon,melanoma in situ, and basal cell and squamous cell carcinomas of the skin
• uncontrolled cardiac disease
• Active infection or chronic infection requiring chronic suppressive antibiotics
• History of hypersensitivity reaction to investigating drugs

Trial design

60 participants in 2 patient groups

AT

Description:

Docetaxel 75 mg/m2, day 1 or paclitaxel 175mg/m2 day 1 plus Epirubicin 75 mg/m2, day 1 or doxorubicine 50mg/m2 day 1 for 6-8 cycles

AT-NP

Description:

docetaxel 75mg/m2,day 1 or paclitaxel 175mg/m2,day 1 plus doxorubicine 50mg/m2,day 1 or epirubicin 75mg/m2, day 1,for3-4 cycles then switch to vinorelbine 25mg/m2, day 1 and day 8 plus cisplatinum 75mg/m2, day 1 for 3-4 cycles