Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer

NCT01732939 | Unknown

• 1 other identifier: 307BCNeo-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• pathological complete response rate

  one year

Secondary Outcomes (1)

• clinical response rate, safety

  one year

Study Arms (2)

AT

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

diaganosis of invasive breast cancer, tumor size \> 2.0cm by MRI or ultrasound or clinical examination.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Affiliated to Military Medical Science, Beijing: lead

Study Sites (1)

Hospital affiliated academy military medical science

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zefei Jiang, MD

  Hospital Affiliated Military Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: November 26, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

CN (1)