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A Multi-Center, Randomized Study of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Neoadjuvant Treatment of Triple-Negative or Her2 Positive Breast Cancer


Phase 3
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Multi-Center, Randomized Study of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Neoadjuvant Treatment of Triple-Negative or Her2 Positive Breast Cancer


Breast cancer is the leading cause of cancer in women in China. Neoadjuvant chemotherapy for
treatment of locally advanced breast cancer has become a standard therapy. Results from
neoadjuvant trials have shown that pathological complete response (pCR) is an independent
predictor of outcome. Docetaxel was introduced into clinical practice in the early 1990s and
has demonstrated good activity in the adjuvant and metastatic settings. Both TC and TAC are
effective regimens in the adjuvant setting. The most optimal regimen in the neoadjuvant
treatment is however unknown. This is especially true in triple-negative or HER2 positive
breast cancer. This study will evaluate the pCR rate of TAC and TC as neoadjuvant treatment
for triple-negative or HER2 positive breast cancer.


Inclusion Criteria:



- Women aged ≥ 18 years and < 70 years

- Karnofsky performance status (KPS) ≥ 70

- At least one measurable disease according to the RECIST. histologically confirmed
invasive breast cancer (excluding inflammatory breast cancer), T2N1 or locally
advanced breast cancer (T3-4N0-3 or T0-4N2-3)

- Biopsy specimens are available for ER, PgR and Her2 detection, patients should be
with triple negative or Her2 positive breast cancer, Her2 positivity is defined as
FISH/CISH Her2 positive or IHC Her2 3+, Triple-negative disease defined as negativity
for ER, PgR and Her2

- Adequate bone marrow function: Neutrophil ≥ 1.5*109/L; Hb ≥ 100g/L; PLT ≥ 100*109/L

- An estimated life expectancy of at least 12 months

- Willing to take biopsy before neoadjuvant chemotherapy and patients must be
accessible for treatment and follow-up

- Women with potential child-bearing must have a negative pregnancy test (urine or
serum) within 7 days of drug administration and agree to use an acceptable method of
birth control to avoid pregnancy for the duration of the study

- Written informed consent according to the GCP

Exclusion Criteria:

- Prior systemic or loco-regional treatment of breast cancer, including chemotherapy

- Metastatic breast cancer

- With a history of malignant tumor except uterine cervix cancer in situ or skin basal
cell carcinoma

- Patients with medical conditions that indicate intolerant to neoadjuvant therapy and
related treatment, including uncontrolled pulmonary disease, diabetes mellitis,
severe infection, active peptic ulcer, coagulation disorder, connective tissue
disease or myelo-suppressive disease

- inadequate liver function (bilirubin > 1.0 times upper normal limit [UNL] and ALT
and/or AST> 1.5 UNL associated with alkaline phosphatase > 2.5 UNL; inadequate renal
function (creatinine > 1.0 times UNL and in case of limit value, Creatinine
clearance < 60 ml/min)

- Contraindication for using dexamethasone

- History of congestive heart failure, uncontrolled or symptomatic angina pectoris,
arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP >
180 mmHg or diastolic BP > 100 mmHg)

- Has peripheral neuropathy ≥ grade 1

- Patient is pregnant or breast feeding

- Known severe hypersensitivity to any drugs in this study

- Treatment with any investigational drugs within 30 days before the beginning of study
treatment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

pathological complete remission (pCR) rate

Outcome Time Frame:

after 6 cycles of neoadjuvant therapy

Safety Issue:

No

Principal Investigator

Kunwei Shen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai Jiao Tong University School of Medicine

Authority:

China: Ethics Committee

Study ID:

NATT

NCT ID:

NCT00912444

Start Date:

July 2009

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • Neoadjuvant
  • Chemotherapy
  • Docetaxel
  • Cyclophosphamide
  • Anthracycline
  • Breast Neoplasms

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