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Multicenter, Randomized, Open-label Phase II Study to Compare the Efficacy and Safety of Trastuzumab and Paclitaxel Based Regimen Plus Carboplatin or Epirubicin as Neoadjuvant Therapy in HER2-positive Breast Cancer Patients

Phase 2
18 Years
69 Years
Open (Enrolling)
HER-2 Positive Breast Cancer

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Trial Information

Multicenter, Randomized, Open-label Phase II Study to Compare the Efficacy and Safety of Trastuzumab and Paclitaxel Based Regimen Plus Carboplatin or Epirubicin as Neoadjuvant Therapy in HER2-positive Breast Cancer Patients

With the increased awareness and development of the diagnosis of breast cancer, more and
more breast cancer is diagnosed at early. Amplification or overexpression, or both, of human
epidermal growth factor receptor-2 (HER2, also known as ERBB2), a transmembrane receptor
tyrosine kinase, is present in around 22% of early breast cancers, 35% of locally advanced
and metastatic tumors, and 40% of inflammatory breast cancers, and is associated with
aggressive disease and poor prognosis. The significant efficacy and good safety profile of
Trastuzumab targeting HER 2 combination with chemotherapy as adjuvant treatment on EBC are
accepted. Currently Trastuzumab has moved to Neoadjuvant treatment combined with
chemotherapy based on many publications, among them pCR is accepted as primary endpoint to
evaluate the efficacy of neoadjuvant therapy.

In the investigators study, Trastuzumab was concomitantly administered with different
chemotherapies after randomization to determine the effect of this approach on the
pathologic CR rates. 100 patients from multicenter would be randomly assigned into two
treatment arms and receive neoadjuvant chemotherapy followed by operation and adjuvant
treatment. Pathological complete response rate (pCR), disease free survival (DFS), response
rates (RR), percentage of conserving breast surgery and adverse events including Serious AEs
and non-serious AEs would be compared. The follow up time for each patients would be 3 years
at most.

Inclusion Criteria:

1. Female patients, presenting for the first time with invasive breast cancer, who have
not received any previous treatment for an invasive malignancy

2. Aged ≥18 years and < 70 years with life expectancy > 12 months

3. Histologically confirmed invasive breast cancer (excluding inflammatory breast
cancer) by core needle biopsy, staged II-III according to TNM Classification System,
with no evidence of metastasis and tumor size ≥3 cm

4. HER2 positive confirmed by IHC 2+ and FISH positivity or IHC 3+

5. At least one measurable lesion according to RECIST criteria 1.1

6. Patients with a left ventricular ejection fraction(LVEF)≥55% by MUGA scan or

7. ECOG PS 0-1

8. Willing to take biopsy before surgery and during chemotherapy and willing to take
pre-operative chemotherapy and related treatment

9. Signed written informed consent; Able to comply with the protocol

Exclusion Criteria:

1. Patient is pregnant or lactating.

2. Women of child-bearing potential must have a negative pregnancy test (urine or serum)
within 7 days of drug administration and agree to take an adequate contraceptive

3. Previous treatment with chemotherapy or hormonal therapy or any prior therapy with an
anti-HER2 therapy for any malignancy.

4. History of congestive heart failure, uncontrolled or symptomatic angina pectoris,
arrhythmia or myocardial infarction

5. Other invasive malignancy (including second primary breast cancer) which could affect
compliance with the protocol or interpretation of results. Patients who have been
curatively treated and free of malignant disease for greater than 5 years are
generally eligible

6. Inadequate bone marrow, hepatic and renal functions as evidenced by the following:

- Neutrophil count of <1500/uL,

- Platelet count of <100,000/uL.

- Haemoglobin <10 g/dL.

- Serum total bilirubin > 1.5*ULN (upper limit of normal),

- ALT or AST > 2.5*ULN,

- Alkaline phosphatase > 2.5*ULN,

- Serum creatinine > 1.5*ULN.

7. Other serious illness or medical condition including:

- Congestive heart failure (NYHA class II, III, IV) or history of documented
congestive heart failure, unstable angina pectoris, myocardial infarction in the
last 6 months, clinically significant valvular heart disease, or high-risk
uncontrolled arrhythmias.

- Patients with dyspnoea at rest due to malignant or other disease (e.g. pulmonary
metastases with lymphangitis) or who require supportive oxygen therapy.

- Active serious uncontrolled infections.

- Poorly controlled diabetes mellitus.

8. Not willing to take pre-operative biopsy or neo-adjuvant therapy

9. Patients with psychiatric disorder or other disease leading to incompliance to the

10. Known hypersensitivity to any ingredient of the regimen

11. Treatment with any investigational drug within 30 days before the beginning of
treatment with study drug.

Type of Study:


Study Design:

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

Outcome Measure:

pathologic complete response rate

Outcome Description:

Percentage of complete pathological response, e.g. no microscopic evidence of residual invasive tumor cells in any resected specimens of the breast and/or axillary nodes.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Zhi-Ming Shao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

August 2011

Completion Date:

February 2015

Related Keywords:

  • HER-2 Positive Breast Cancer
  • HER2
  • Breast cancer
  • neoadjuvant chemotherapy
  • efficacy
  • safety
  • Breast Neoplasms