Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer

NCT ID: NCT01732939

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-05-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Affiliated to Military Medical Science, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zefei Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Affiliated Military Medical Science

Locations

Hospital affiliated academy military medical science

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Tao Wang, MD

Role: primary

8610-66947430

Shaohua ZHANG, MD

Role: backup

8610-66947173

Other Identifiers

307BCNeo-01

Identifier Type: -

Identifier Source: org_study_id