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Phase 3
18 Years
40 Years
Open (Enrolling)
Female
Breast Neoplasms

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Trial Information


Inclusion Criteria:



- Female patients, age 18~40

- Unilateral, operable, histologically confirmed adenocarcinoma of the breast

- Stage I-III

- Primary surgery with clear margins plus axillary dissection

- Able to start protocol Rx within 4 weeks of surgery

- HER-2 positive (IHC 3+ OR FISH+) and sequential use of trastuzumab followed by
chemotherapy

- Occult breast cancer with histologically confirmed primary invasive carcinoma or DICS
with microinvasion in the ipsilateral breast after surgery

- ECOG performance status 0-1

- Adequate cardiac, renal, hepatic and hematologic function

Exclusion Criteria:

- Metastatic disease

- Bilateral breast cancer (synchronous or metachronous)

- Prior radiation therapy, hormonal therapy and chemotherapy for breast cancer

- Previous cancer (except treated basal cell and squamous cell carcinoma of the skin or
cancer of the uterine cervix)

- HER-2 positive (IHC 3+ OR FISH+) and concurrence use of adjuvant chemotherapy and
trastuzumab

- Documented history of cardiac disease contradiction anthracyclines

- Concurrent serious illness

- Peripheral neuropathy of CTC grade>1

- History of hypersensitivity to drugs formulated in Cremophor EL polyoxyethylated
castor oil), the vehicle used for commercial paclitaxel formulations

- Pregnancy or lactation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease-free survival

Outcome Time Frame:

every one year

Safety Issue:

Yes

Principal Investigator

Zhimin Shao

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital, Fudan University

Authority:

China: Ethics Committee

Study ID:

SHBCC09007

NCT ID:

NCT01026116

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

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