Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01732939

Enrollment

Registered

2012-11-26

Start date

2012-05-31

Completion date

2014-05-31

Last updated

2014-02-19

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

Conditions

Breast Cancer

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
pathological complete response rate	one year

Secondary

Measure	Time frame
clinical response rate, safety	one year

Countries

China

Outcome results