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Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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.

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

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

pathological complete response rate

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Zefei Jiang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Affiliated Military Medical Science


China: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

May 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms